Science.gov

Sample records for medical imaging devices

  1. Use of mobile devices for medical imaging.

    PubMed

    Hirschorn, David S; Choudhri, Asim F; Shih, George; Kim, Woojin

    2014-12-01

    Mobile devices have fundamentally changed personal computing, with many people forgoing the desktop and even laptop computer altogether in favor of a smaller, lighter, and cheaper device with a touch screen. Doctors and patients are beginning to expect medical images to be available on these devices for consultative viewing, if not actual diagnosis. However, this raises serious concerns with regard to the ability of existing mobile devices and networks to quickly and securely move these images. Medical images often come in large sets, which can bog down a network if not conveyed in an intelligent manner, and downloaded data on a mobile device are highly vulnerable to a breach of patient confidentiality should that device become lost or stolen. Some degree of regulation is needed to ensure that the software used to view these images allows all relevant medical information to be visible and manipulated in a clinically acceptable manner. There also needs to be a quality control mechanism to ensure that a device's display accurately conveys the image content without loss of contrast detail. Furthermore, not all mobile displays are appropriate for all types of images. The smaller displays of smart phones, for example, are not well suited for viewing entire chest radiographs, no matter how small and numerous the pixels of the display may be. All of these factors should be taken into account when deciding where, when, and how to use mobile devices for the display of medical images. Copyright © 2014 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  2. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image hardcopy device. 892.2040 Section 892.2040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device....

  3. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image hardcopy device. 892.2040 Section 892.2040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device....

  4. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image storage device. 892.2010 Section 892.2010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device....

  5. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image storage device. 892.2010 Section 892.2010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device....

  6. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image storage device. 892.2010 Section 892.2010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device....

  7. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image hardcopy device. 892.2040 Section 892.2040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device....

  8. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image hardcopy device. 892.2040 Section 892.2040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device....

  9. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image storage device. 892.2010 Section 892.2010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device....

  10. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image hardcopy device. 892.2040 Section 892.2040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device....

  11. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image communications device. 892.2020 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image...

  12. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image communications device. 892.2020 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image...

  13. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image communications device. 892.2020 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image...

  14. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image communications device. 892.2020 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image...

  15. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image communications device. 892.2020 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image...

  16. Image Quality Characteristics of Handheld Display Devices for Medical Imaging

    PubMed Central

    Yamazaki, Asumi; Liu, Peter; Cheng, Wei-Chung; Badano, Aldo

    2013-01-01

    Handheld devices such as mobile phones and tablet computers have become widespread with thousands of available software applications. Recently, handhelds are being proposed as part of medical imaging solutions, especially in emergency medicine, where immediate consultation is required. However, handheld devices differ significantly from medical workstation displays in terms of display characteristics. Moreover, the characteristics vary significantly among device types. We investigate the image quality characteristics of various handheld devices with respect to luminance response, spatial resolution, spatial noise, and reflectance. We show that the luminance characteristics of the handheld displays are different from those of workstation displays complying with grayscale standard target response suggesting that luminance calibration might be needed. Our results also demonstrate that the spatial characteristics of handhelds can surpass those of medical workstation displays particularly for recent generation devices. While a 5 mega-pixel monochrome workstation display has horizontal and vertical modulation transfer factors of 0.52 and 0.47 at the Nyquist frequency, the handheld displays released after 2011 can have values higher than 0.63 at the respective Nyquist frequencies. The noise power spectra for workstation displays are higher than 1.2×10−5 mm2 at 1 mm−1, while handheld displays have values lower than 3.7×10−6 mm2. Reflectance measurements on some of the handheld displays are consistent with measurements for workstation displays with, in some cases, low specular and diffuse reflectance coefficients. The variability of the characterization results among devices due to the different technological features indicates that image quality varies greatly among handheld display devices. PMID:24236113

  17. [Study on the image file conformance to DICOM standard about medical imaging device].

    PubMed

    Qiu, Minghui

    2013-09-01

    The format of medical image file conformance to DICOM standard have important influence on users of the PACS. This paper summarized the results of the writer's study on the image file conformance to DICOM standard about medical imaging device for many years. The questions of medical image file no conformance to DICOM standard are pointed in detail and the questions resulted from the troubled image files are analyzed. Finally, the methods of avoiding image file no conformance to DICOM standard are presented.

  18. Monitoring biofilm attachment on medical devices surfaces using hyperspectral imaging

    NASA Astrophysics Data System (ADS)

    Le, Hanh N. D.; Hitchins, Victoria M.; Ilev, Ilko K.; Kim, Do-Hyun

    2014-02-01

    Microbial biofilm is a colony of single bacteria cells (planktonic) that attached to surfaces, attract other microorganisms to attach and grow, and together they build an extracellular matrix composed of polysaccharides, protein, and DNA. Eventually, some cells will detach and spread to other surface. Biofilm on medical devices can cause severe infection to all age ranges from infant to adult. Therefore, it is important to detect biofilm in a fast and efficient manner. Hyperspectral imaging was utilized for distinguishing wide area of biofilm coverage on various materials and on different textures of stainless steeltest coupons. Not only is the coverage of biofilm important, but also the shear stress of biofilm on the attached surfaces is significant. This study investigates the effects of shear stress on the adhesion of biofilms on common medical device surfaces such as glass, polycarbonate, polytetrafluoroethylene, and stainless steel with different textures. Biofilm was grown using Ps. aeruginosa and growth was monitored after 24 and 48 hours at 37° C. The coupons covered with biofilm were tilted at 45 degrees and 90 degrees for 30 seconds to induce shear stress and Hyperspectral images were taken. We hypothesize that stronger attachment on rough surface would be able to withstand greater shear stress compared to smooth surface.

  19. Image quality assessment for teledermatology: from consumer devices to a dedicated medical device

    NASA Astrophysics Data System (ADS)

    Amouroux, Marine; Le Cunff, Sébastien; Haudrechy, Alexandre; Blondel, Walter

    2017-03-01

    Aging population as well as growing incidence of type 2 diabetes induce a growing incidence of chronic skin disorders. In the meantime, chronic shortage of dermatologists leaves some areas underserved. Remote triage and assistance to homecare nurses (known as "teledermatology") appear to be promising solutions to provide dermatological valuation in a decent time to patients wherever they live. Nowadays, teledermatology is often based on consumer devices (digital tablets, smartphones, webcams) whose photobiological and electrical safety levels do not match with medical devices' levels. The American Telemedicine Association (ATA) has published recommendations on quality standards for teledermatology. This "quick guide" does not address the issue of image quality which is critical in domestic environments where lighting is rarely reproducible. Standardized approaches of image quality would allow clinical trial comparison, calibration, manufacturing quality control and quality insurance during clinical use. Therefore, we defined several critical metrics using calibration charts (color and resolution charts) in order to assess image quality such as resolution, lighting uniformity, color repeatability and discrimination of key couples of colors. Using such metrics, we compared quality of images produced by several medical devices (handheld and video-dermoscopes) as well as by consumer devices (digital tablet and cameras) widely spread among dermatologists practice. Since diagnosis accuracy may be impaired by "low quality-images", this study highlights that, from an optical point of view, teledermatology should only be performed using medical devices. Furthermore, a dedicated medical device should probably be developed for the time follow-up of skin lesions often managed in teledermatology such as chronic wounds that require i) noncontact imaging of ii) large areas of skin surfaces, both criteria that cannot be matched using dermoscopes.

  20. Fiber bundle probes for interconnecting miniaturized medical imaging devices

    NASA Astrophysics Data System (ADS)

    Zamora, Vanessa; Hofmann, Jens; Marx, Sebastian; Herter, Jonas; Nguyen, Dennis; Arndt-Staufenbiel, Norbert; Schröder, Henning

    2017-02-01

    Miniaturization of medical imaging devices will significantly improve the workflow of physicians in hospitals. Photonic integrated circuit (PIC) technologies offer a high level of miniaturization. However, they need fiber optic interconnection solutions for their functional integration. As part of European funded project (InSPECT) we investigate fiber bundle probes (FBPs) to be used as multi-mode (MM) to single-mode (SM) interconnections for PIC modules. The FBP consists of a set of four or seven SM fibers hexagonally distributed and assembled into a holder that defines a multicore connection. Such a connection can be used to connect MM fibers, while each SM fiber is attached to the PIC module. The manufacturing of these probes is explored by using well-established fiber fusion, epoxy adhesive, innovative adhesive and polishing techniques in order to achieve reliable, low-cost and reproducible samples. An innovative hydrofluoric acid-free fiber etching technology has been recently investigated. The preliminary results show that the reduction of the fiber diameter shows a linear behavior as a function of etching time. Different etch rate values from 0.55 μm/min to 2.3 μm/min were found. Several FBPs with three different type of fibers have been optically interrogated at wavelengths of 630nm and 1550nm. Optical losses are found of approx. 35dB at 1550nm for FBPs composed by 80μm fibers. Although FBPs present moderate optical losses, they might be integrated using different optical fibers, covering a broad spectral range required for imaging applications. Finally, we show the use of FBPs as promising MM-to-SM interconnects for real-world interfacing to PIC's.

  1. Monitoring of biofilm formation on different material surfaces of medical devices using hyperspectral imaging method

    NASA Astrophysics Data System (ADS)

    Kim, Do-Hyun; Kim, Moon S.; Hwang, Jeeseong

    2012-03-01

    Contamination of the inner surface of indwelling (implanted) medical devices by microbial biofilm is a serious problem. Some microbial bacteria such as Escherichia coli form biofilms that lead to potentially lifethreatening infections. Other types of medical devices such as bronchoscopes and duodenoscopes account for the highest number of reported endoscopic infections where microbial biofilm is one of the major causes for these infections. We applied a hyperspectral imaging method to detect biofilm contamination on the surface of several common materials used for medical devices. Such materials include stainless steel, titanium, and stainless-steeltitanium alloy. Potential uses of hyperspectral imaging technique to monitor biofilm attachment to different material surfaces are discussed.

  2. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., and digital memory. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9. ...

  3. Globus MEDICUS - federation of DICOM medical imaging devices into healthcare Grids.

    PubMed

    Erberich, Stephan G; Silverstein, Jonathan C; Chervenak, Ann; Schuler, Robert; Nelson, Marvin D; Kesselman, Carl

    2007-01-01

    The Digital Imaging and Communications in Medicine (DICOM) standard defines Radiology medical device interoperability and image data exchange between modalities, image databases - Picture Archiving and Communication Systems (PACS) - and image review end-points. However the scope of DICOM and PACS technology is currently limited to the trusted and static environment of the hospital. In order to meet the demand for ad-hoc tele-radiology and image guided medical procedures within the global healthcare enterprise, a new technology must provide mobility, security, flexible scale of operations, and rapid responsiveness for DICOM medical devices and subsequently medical image data. Grid technology, an informatics approach to securely federate independently operated computing, storage, and data management resources at the global scale over public networks, meets these core requirements. Here we present an approach to federate DICOM and PACS devices for large-scale medical image workflows within a global healthcare enterprise. The Globus MEDICUS (Medical Imaging and Computing for Unified Information Sharing) project uses the standards-based Globus Toolkit Grid infrastructure to vertically integrate a new service for DICOM devices - the DICOM Grid Interface Service (DGIS). This new service translates between DICOM and Grid operations and thus transparently extends DICOM to Globus based Grid infrastructure. This Grid image workflow paradigm has been designed to provide not only solutions for global image communication, but fault-tolerance and disaster recovery using Grid data replication technology. Actual use-case of 40 MEDICUS Grid connected international hospitals of the Childerns Oncology Group and the Neuroblastoma Cancer Foundation and further clinical applications are discussed. The open-source Globus MEDICU http://dev.globus.org/wiki/Incubator/MEDICUS.

  4. A service protocol for post-processing of medical images on the mobile device

    NASA Astrophysics Data System (ADS)

    He, Longjun; Ming, Xing; Xu, Lang; Liu, Qian

    2014-03-01

    With computing capability and display size growing, the mobile device has been used as a tool to help clinicians view patient information and medical images anywhere and anytime. It is uneasy and time-consuming for transferring medical images with large data size from picture archiving and communication system to mobile client, since the wireless network is unstable and limited by bandwidth. Besides, limited by computing capability, memory and power endurance, it is hard to provide a satisfactory quality of experience for radiologists to handle some complex post-processing of medical images on the mobile device, such as real-time direct interactive three-dimensional visualization. In this work, remote rendering technology is employed to implement the post-processing of medical images instead of local rendering, and a service protocol is developed to standardize the communication between the render server and mobile client. In order to make mobile devices with different platforms be able to access post-processing of medical images, the Extensible Markup Language is taken to describe this protocol, which contains four main parts: user authentication, medical image query/ retrieval, 2D post-processing (e.g. window leveling, pixel values obtained) and 3D post-processing (e.g. maximum intensity projection, multi-planar reconstruction, curved planar reformation and direct volume rendering). And then an instance is implemented to verify the protocol. This instance can support the mobile device access post-processing of medical image services on the render server via a client application or on the web page.

  5. Introduction: feature issue on phantoms for the performance evaluation and validation of optical medical imaging devices.

    PubMed

    Hwang, Jeeseong; Ramella-Roman, Jessica C; Nordstrom, Robert

    2012-06-01

    The editors introduce the Biomedical Optics Express feature issue on "Phantoms for the Performance Evaluation and Validation of Optical Medical Imaging Devices." This topic was the focus of a technical workshop that was held on November 7-8, 2011, in Washington, D.C. The feature issue includes 13 contributions from workshop attendees.

  6. Medical Device Safety

    MedlinePlus

    ... More Medical Device Recalls Recent Medical Device Safety Communications FDA analyses and recommendations for patients and health ... about ongoing medical device safety issues. FDA Safety Communication Date FDA Warns Of Potentially Contaminated SPS-1 ...

  7. Real-time volume rendering of digital medical images on an iOS device

    NASA Astrophysics Data System (ADS)

    Noon, Christian; Holub, Joseph; Winer, Eliot

    2013-03-01

    Performing high quality 3D visualizations on mobile devices, while tantalizingly close in many areas, is still a quite difficult task. This is especially true for 3D volume rendering of digital medical images. Allowing this would empower medical personnel a powerful tool to diagnose and treat patients and train the next generation of physicians. This research focuses on performing real time volume rendering of digital medical images on iOS devices using custom developed GPU shaders for orthogonal texture slicing. An interactive volume renderer was designed and developed with several new features including dynamic modification of render resolutions, an incremental render loop, a shader-based clipping algorithm to support OpenGL ES 2.0, and an internal backface culling algorithm for properly sorting rendered geometry with alpha blending. The application was developed using several application programming interfaces (APIs) such as OpenSceneGraph (OSG) as the primary graphics renderer coupled with iOS Cocoa Touch for user interaction, and DCMTK for DICOM I/O. The developed application rendered volume datasets over 450 slices up to 50-60 frames per second, depending on the specific model of the iOS device. All rendering is done locally on the device so no Internet connection is required.

  8. Medical Device Safety

    MedlinePlus

    A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They range ... may need one in a hospital. To use medical devices safely Know how your device works. Keep instructions ...

  9. Terahertz Imaging System for Medical Applications and Related High Efficiency Terahertz Devices

    NASA Astrophysics Data System (ADS)

    Ouchi, Toshihiko; Kajiki, Kousuke; Koizumi, Takayuki; Itsuji, Takeaki; Koyama, Yasushi; Sekiguchi, Ryota; Kubota, Oichi; Kawase, Kodo

    2013-07-01

    A terahertz (THz) imaging system and high efficient terahertz sources and detectors for medical applications were developed. A fiber laser based compact time domain terahertz tomography system was developed with a high depth resolution of less than 20 μm. Three-dimensional images of porcine skin were obtained including some physical properties such as applied skin creams. The discrimination between healthy human tissue and tumor tissue has been achieved using reflection spectra. To improve the THz imaging system, a ridge waveguide LiNbO3 based nonlinear terahertz generator was studied to achieve high output power. A ridge waveguide with 5-7 μm width was designed for high efficiency emission from the LiNbO3 crystal by the electro-optic Cherenkov effect. Terahertz electronic sources and detectors were also realized for future imaging systems. As electronic source devices, resonant tunneling diode (RTD) oscillators with a patch antenna were fabricated using an InGaAs/InAlAs/AlAs triple barrier structure. On the other side, Schottky barrier diode (SBD) detectors with a log-periodic antenna were fabricated by thin-film technology on a Si substrate. Both devices operate above 1 THz at room temperature. This electronic THz device set could provide a future high performance imaging system.

  10. Medical devices: US medical device regulation.

    PubMed

    Jarow, Jonathan P; Baxley, John H

    2015-03-01

    Medical devices are regulated by the US Food and Drug Administration (FDA) within the Center for Devices and Radiological Health. Center for Devices and Radiological Health is responsible for protecting and promoting the public health by ensuring the safety, effectiveness, and quality of medical devices, ensuring the safety of radiation-emitting products, fostering innovation, and providing the public with accurate, science-based information about the products we oversee, throughout the total product life cycle. The FDA was granted the authority to regulate the manufacturing and marketing of medical devices in 1976. It does not regulate the practice of medicine. Devices are classified based on complexity and level of risk, and "pre-1976" devices were allowed to remain on the market after being classified without FDA review. Post-1976 devices of lower complexity and risk that are substantially equivalent to a marketed "predicate" device may be cleared through the 510(k) premarket notification process. Clinical data are typically not needed for 510(k) clearance. In contrast, higher-risk devices typically require premarket approval. Premarket approval applications must contain data demonstrating reasonable assurance of safety and efficacy, and this information typically includes clinical data. For novel devices that are not high risk, the de novo process allows FDA to simultaneously review and classify new devices. Devices that are not legally marketed are permitted to be used for clinical investigation purposes in the United States under the Investigational Device Exemptions regulation.

  11. An average enumeration method of hyperspectral imaging data for quantitative evaluation of medical device surface contamination

    PubMed Central

    Le, Hanh N. D.; Kim, Moon S.; Hwang, Jeeseong; Yang, Yi; Thainual, Paweena U; Kang, Jin U.; Kim, Do-Hyun

    2014-01-01

    We propose a quantification method called Mapped Average Principal component analysis Score (MAPS) to enumerate the contamination coverage on common medical device surfaces. The method was adapted from conventional Principal Component Analysis (PCA) on non-overlapped regions of a full frame hyperspectral image to resolve the percentage of contamination from the substrate. The concept was proven by using a controlled contamination sample with artificial test soil and color simulating organic mixture, and was further validated using a bacterial system including biofilm on stainless steel surface. We also validate the results of MAPS with other statistical spectral analysis including Spectral Angle Mapper (SAM). The proposed method provides an alternative quantification method for hyperspectral imaging data, which can be easily implemented by basic PCA analysis. PMID:25360377

  12. Monitoring of biofilm formation on different material surfaces of medical devices using hyperspectral imaging method

    USDA-ARS?s Scientific Manuscript database

    Contamination of the inner surface of indwelling (implanted) medical devices by microbial biofilm is a serious problem. Some microbial bacteria such as Escherichia coli form biofilms that lead to potentially life-threatening infections. Other types of medical devices such as bronchoscopes and duod...

  13. Medical Imaging.

    ERIC Educational Resources Information Center

    Barker, M. C. J.

    1996-01-01

    Discusses four main types of medical imaging (x-ray, radionuclide, ultrasound, and magnetic resonance) and considers their relative merits. Describes important recent and possible future developments in image processing. (Author/MKR)

  14. Implantable Medical Devices

    MedlinePlus

    ... a Heart Attack Treatment of a Heart Attack Life After a Heart Attack Heart Failure About Heart Failure ... Attack Introduction Medications Surgical Procedures Implantable Medical Devices • Life After a Heart Attack • Heart Attack Tools & Resources • Support ...

  15. [New Medical Device Evaluation].

    PubMed

    Ikeda, Koji

    2016-01-01

    In this presentation, as a member of the Harmonization by Doing (HBD) project, I discuss the significance of regulatory science in global medical device development and our experience in the international collaboration process for medical devices. In Japan, most innovative medical therapeutic devices were previously developed and exported by foreign-based companies. Due to this device lag, Japanese had minimal opportunities for receiving treatment with innovative medical devices. To address this issue, the Japanese government has actively accepted foreign clinical trial results and promoted global clinical trials in projects such as HBD. HBD is a project with stakeholders from academia, regulatory authorities, and industry in the US and Japan to promote global clinical trials and reduce device lags. When the project started, medical device clinical trials were not actively conducted in Japan at not just hospitals but also at medical device companies. We started to identify issues under the concept of HBD. After 10 years, we have now become key members in global clinical trials and able to obtain approvals without delay. Recently, HBD has started promoting international convergence. Physicians and regulatory authorities play central roles in compiling guidelines for the clinical evaluation of medical device development, which will be a more active field in the near future. The guidelines compiled will be confirmed with members of academia and regulatory authorities in the United Sates.

  16. Opportunities for Fluorochlorozirconate and Other Glass-Ceramic Detectors in Medical Imaging Devices

    PubMed Central

    Johnson, Jacqueline A.; Leonard, Russell L.; Lubinsky, AR; Schweizer, Stefan

    2017-01-01

    This article gives an overview of fluorochlorozirconate glass-ceramic scintillators and storage phosphor materials: how they are synthesized, what their properties are, and how they can be used in medical imaging. Such materials can enhance imaging in x-ray radiography, especially mammography and dental imaging, computed tomography, and positron emission tomography. Although focusing on fluorochlorozirconate materials, the reader will find the discussion is relevant to other luminescent glass and glass-ceramic systems.

  17. An average enumeration method of hyperspectral imaging data for quantitative evaluation of medical device surface contamination

    USDA-ARS?s Scientific Manuscript database

    We propose a quantification method called Mapped Average Principal Component Analysis Score (MAPS) to enumerate the contamination coverage on common medical device surfaces. The method was adapted from conventional Principal Component Analysis (PCA) on non-overlapped regions on a full frame hyperspe...

  18. An implementation of wireless medical image transmission system on mobile devices.

    PubMed

    Lee, SangBock; Lee, Taesoo; Jin, Gyehwan; Hong, Juhyun

    2008-12-01

    The advanced technology of computing system was followed by the rapid improvement of medical instrumentation and patient record management system. The typical examples are hospital information system (HIS) and picture archiving and communication system (PACS), which computerized the management procedure of medical records and images in hospital. Because these systems were built and used in hospitals, doctors out of hospital have problems to access them immediately on emergent cases. To solve these problems, this paper addressed the realization of system that could transmit the images acquired by medical imaging systems in hospital to the remote doctors' handheld PDA's using CDMA cellular phone network. The system consists of server and PDA. The server was developed to manage the accounts of doctors and patients and allocate the patient images to each doctor. The PDA was developed to display patient images through remote server connection. To authenticate the personal user, remote data access (RDA) method was used in PDA accessing the server database and file transfer protocol (FTP) was used to download patient images from the remove server. In laboratory experiments, it was calculated to take ninety seconds to transmit thirty images with 832 x 488 resolution and 24 bit depth and 0.37 Mb size. This result showed that the developed system has no problems for remote doctors to receive and review the patient images immediately on emergent cases.

  19. Medical imaging

    NASA Astrophysics Data System (ADS)

    Elliott, Alex

    2005-07-01

    Diagnostic medical imaging is a fundamental part of the practice of modern medicine and is responsible for the expenditure of considerable amounts of capital and revenue monies in healthcare systems around the world. Much research and development work is carried out, both by commercial companies and the academic community. This paper reviews briefly each of the major diagnostic medical imaging techniques—X-ray (planar and CT), ultrasound, nuclear medicine (planar, SPECT and PET) and magnetic resonance. The technical challenges facing each are highlighted, with some of the most recent developments. In terms of the future, interventional/peri-operative imaging, the advancement of molecular medicine and gene therapy are identified as potential areas of expansion.

  20. Optomechanical medical devices (instruments)

    NASA Astrophysics Data System (ADS)

    Reiss, Roger S.

    2004-03-01

    Optomechanical Medical Devices (Instruments) use lightwaves (UV, Visible, IR) for one or more of the following functions; to observe, to measure, to record, to test (align) and or to cut/repair. The evolution of Optomechanical Medical Devices probably started when the first torch or candle or petrochemical lamp used a polished reflector (possibly with a concave configuration) to examine a part of a patient's body (possibly a wound).Once the glass lens was invented, light sources of any type could be forcussed to increase illuminating power on a selected area. Medical Devices have come a great distance since these early items. Skipping across time to three rather significant inventions and advancements, we are well into the era of Laser and Fiber Optics and Advanced Photodetectors, all being integrated into Medical Devices. The most notable fields have been Ophthalmology, Dermatology, and Surgery. All three fields have been able to incorporate both the use of the Laser and the use of Fiber Optics (and at times the use of Photodetectors), into a single device (instrument). Historical: Philipp Bozzini (a Doctor, maybe) in the early 1800's used a hollow tube (tube material not identified) to project the light of a candle through the tube to view a patient's 'what ever'. Only Philipp, the patient and G-d knows what was being viewed. This ws the first recorded information on what could be considered the very first 'Endoscope examination'

  1. In vivo evaluation of medical device-associated inflammation using a macrophage-specific Positron Emission Tomography (PET) imaging probe

    PubMed Central

    Zhou, Jun; Hao, Guiyang; Weng, Hong; Tsai, Yi-Ting; Baker, David W.; Sun, Xiankai; Tang, Liping

    2013-01-01

    To image implant-surrounding activated macrophages, a macrophage-specific PET probe was prepared by conjugating folic acid (FA) and 2,2′,2″,2‴-(1,4,7,10-tetraazacyclododecane-1,4,7,10-tetrayl) tetracetic acid (DOTA) to polyethylene glycol (PEG) and then labeling the conjugate with Ga-68. In vivo PET imaging evaluations demonstrate that the probe is able to detect foreign body reactions, and more importantly, quantify the degree of inflammatory responses to an implanted medical device. These results were further validated by histological analysis. PMID:23481649

  2. Medical device regulation for manufacturers.

    PubMed

    McAllister, P; Jeswiet, J

    2003-01-01

    Manufacturers of medical devices are held to a higher standard than manufacturers of many other products due to the potential severity of the consequences of introducing inferior or unsafe products to the market-place. In Canada, the medical device industry is regulated by Health Canada under the Medical Device Regulations of the Food and Drug Act. The Medical Device Regulations define requirements of medical device design, development and manufacture to ensure that products reaching the public are safe and effective. Health Canada also requires that medical device manufacturers maintain distribution records to ensure that devices can be traced to the source and consumers can be contacted successfully in the event that a device is recalled. Medical devices exported from Canada must be compliant with the regulations of the country of import. The Canadian Medical Device Regulations were based on the Medical Device Directives of the European Union thus facilitating approval of Canadian devices for the European market. The United States Food and Drug Administration has separate and distinct requirements for safety and quality of medical devices. While effort has been made to facilitate approval and trade of Canadian medical devices in the United States and the European Union, obtaining approval from multiple regulatory bodies can result in increased device development time and cost. The Global Harmonization Task Force is an organization composed of members from Japanese, Australian, European, Canadian and American medical device regulatory bodies. This organization was formed with the objective of harmonizing medical device regulations in an effort to facilitate international trade and standardize the quality of medical devices available to all countries. This paper discusses the requirements that must be met by manufacturers when designing and manufacturing medical devices.

  3. 76 FR 8637 - Medical Devices; Medical Device Data Systems

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-15

    ...The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions......

  4. Device for wavelength-selective imaging

    SciTech Connect

    Frangioni, John V.

    2010-09-14

    An imaging device captures both a visible light image and a diagnostic image, the diagnostic image corresponding to emissions from an imaging medium within the object. The visible light image (which may be color or grayscale) and the diagnostic image may be superimposed to display regions of diagnostic significance within a visible light image. A number of imaging media may be used according to an intended application for the imaging device, and an imaging medium may have wavelengths above, below, or within the visible light spectrum. The devices described herein may be advantageously packaged within a single integrated device or other solid state device, and/or employed in an integrated, single-camera medical imaging system, as well as many non-medical imaging systems that would benefit from simultaneous capture of visible-light wavelength images along with images at other wavelengths.

  5. Medical imaging.

    PubMed Central

    Kreel, L.

    1991-01-01

    There is now a wide choice of medical imaging to show both focal and diffuse pathologies in various organs. Conventional radiology with plain films, fluoroscopy and contrast medium have many advantages, being readily available with low-cost apparatus and a familiarity that almost leads to contempt. The use of plain films in chest disease and in trauma does not need emphasizing, yet there are still too many occasions when the answer obtainable from a plain radiograph has not been available. The film may have been mislaid, or the examination was not requested, or the radiograph had been misinterpreted. The converse is also quite common. Examinations are performed that add nothing to patient management, such as skull films when CT will in any case be requested or views of the internal auditory meatus and heal pad thickness in acromegaly, to quote some examples. Other issues are more complicated. Should the patient who clinically has gall-bladder disease have more than a plain film that shows gall-stones? If the answer is yes, then why request a plain film if sonography will in any case be required to 'exclude' other pathologies especially of the liver or pancreas? But then should cholecystography, CT or scintigraphy be added for confirmation? Quite clearly there will be individual circumstances to indicate further imaging after sonography but in the vast majority of patients little or no extra information will be added. Statistics on accuracy and specificity will, in the case of gall-bladder pathology, vary widely if adenomyomatosis is considered by some to be a cause of symptoms or if sonographic examinations 'after fatty meals' are performed. The arguments for or against routine contrast urography rather than sonography are similar but the possibility of contrast reactions and the need to limit ionizing radiation must be borne in mind. These diagnostic strategies are also being influenced by their cost and availability; purely pragmatic considerations are not

  6. Medical imaging

    SciTech Connect

    Schneider, R.H.; Dwyer, S.J.

    1987-01-01

    This book contains papers from 26 sessions. Some of the session titles are: Tomographic Reconstruction, Radiography, Fluoro/Angio, Imaging Performance Measures, Perception, Image Processing, 3-D Display, and Printers, Displays, and Digitizers.

  7. Medical device alarms.

    PubMed

    Borowski, Matthias; Görges, Matthias; Fried, Roland; Such, Olaf; Wrede, Christian; Imhoff, Michael

    2011-04-01

    The high number of false positive alarms has long been known to be a serious problem in critical care medicine - yet it remains unresolved. At the same time, threats to patient safety due to missing or suppressed alarms are being reported. The purpose of this paper is to present results from a workshop titled "Too many alarms? Too few alarms?" organized by the Section Patient Monitoring and the Workgroup Alarms of the German Association of Biomedical Engineering of the Association for Electrical, Electronic and Information Technologies. The current situation regarding alarms and their problems in intensive care, such as lack of clinical relevance, alarm fatigue, workload increases due to clinically irrelevant alarms, usability problems in alarm systems, problems with manuals and training, and missing alarms due to operator error are outlined, followed by a discussion of solutions and strategies to improve the current situation. Finally, the need for more research and development, focusing on signal quality considerations, networking of medical devices at the bedside, diagnostic alarms and predictive warnings, usability of alarm systems, education of healthcare providers, creation of annotated clinical databases for testing, standardization efforts, and patient monitoring in the regular ward, are called for.

  8. Imaging medical imaging

    NASA Astrophysics Data System (ADS)

    Journeau, P.

    2015-03-01

    This paper presents progress on imaging the research field of Imaging Informatics, mapped as the clustering of its communities together with their main results by applying a process to produce a dynamical image of the interactions between their results and their common object(s) of research. The basic side draws from a fundamental research on the concept of dimensions and projective space spanning several streams of research about three-dimensional perceptivity and re-cognition and on their relation and reduction to spatial dimensionality. The application results in an N-dimensional mapping in Bio-Medical Imaging, with dimensions such as inflammatory activity, MRI acquisition sequencing, spatial resolution (voxel size), spatiotemporal dimension inferred, toxicity, depth penetration, sensitivity, temporal resolution, wave length, imaging duration, etc. Each field is represented through the projection of papers' and projects' `discriminating' quantitative results onto the specific N-dimensional hypercube of relevant measurement axes, such as listed above and before reduction. Past published differentiating results are represented as red stars, achieved unpublished results as purple spots and projects at diverse progress advancement levels as blue pie slices. The goal of the mapping is to show the dynamics of the trajectories of the field in its own experimental frame and their direction, speed and other characteristics. We conclude with an invitation to participate and show a sample mapping of the dynamics of the community and a tentative predictive model from community contribution.

  9. Medical Imaging.

    ERIC Educational Resources Information Center

    Jaffe, C. Carl

    1982-01-01

    Describes principle imaging techniques, their applications, and their limitations in terms of diagnostic capability and possible adverse biological effects. Techniques include film radiography, computed tomography, nuclear medicine, positron emission tomography (PET), ultrasonography, nuclear magnetic resonance, and digital radiography. PET has…

  10. Medical Imaging.

    ERIC Educational Resources Information Center

    Jaffe, C. Carl

    1982-01-01

    Describes principle imaging techniques, their applications, and their limitations in terms of diagnostic capability and possible adverse biological effects. Techniques include film radiography, computed tomography, nuclear medicine, positron emission tomography (PET), ultrasonography, nuclear magnetic resonance, and digital radiography. PET has…

  11. Clinical applications of image-based airway computational fluid dynamics: assessment of inhalation medication and endobronchial devices

    NASA Astrophysics Data System (ADS)

    De Backer, Jan W.; Vos, Wim G.; Germonpré, Paul; Salgado, Rodrigo; Parizel, Paul M.; De Backer, Wilfried

    2009-02-01

    Computational fluid dynamics (CFD) is a technique that is used increasingly in the biomedical field. Solving the flow equations numerically provides a convenient way to assess the efficiency of therapies and devices, ranging from cardiovascular stents and heart valves to hemodialysis workflows. Also in the respiratory field CFD has gained increasing interest, especially through the combination of three dimensional image reconstruction which results in highend patient-specific models. This paper provides an overview of clinical applications of CFD through image based modeling, resulting from recent studies performed in our center. We focused on two applications: assessment of the efficiency of inhalation medication and analysis of endobronchial valve placement. In the first application we assessed the mode of action of a novel bronchodilator in 10 treated patients and 4 controls. We assessed the local volume increase and resistance change based on the combination of imaging and CFD. We found a good correlation between the changes in volume and resistance coming from the CFD results and the clinical tests. In the second application we assessed the placement and effect of one way endobronchial valves on respiratory function in 6 patients. We found a strong patientspecific result of the therapy where in some patients the therapy resulted in complete atelectasis of the target lobe while in others the lobe remained inflated. We concluded from these applications that CFD can provide a better insight into clinically relevant therapies.

  12. Assurance Cases for Medical Devices

    DTIC Science & Technology

    2011-04-28

    SEI’s  Research,  Technology,  and  System   Solu2ons  program.  With  his  colleague  John   Goodenough ,  Weinstock...contact The SEI and Medical Devices *Charles B. Weinstock and John B. Goodenough , Towards an Assurance Case Practice for Medical Devices, CMU/SEI-2009-TN

  13. Using medical imaging for the detection of adverse events ("incidents") during the utilization of left ventricular assist devices in adult patients with advanced heart failure.

    PubMed

    Kaufmann, Friedrich; Krabatsch, Thomas

    2016-05-01

    Ventricular assist devices (VAD) are used for mechanical support of the terminally failing heart. Failure of these life supporting systems can be fatal. Early and reliable detection of any upcoming problems is mandatory and is crucial for the outcome. Medical imaging methods are described within this review, which are not only essential for diagnosis of typically VAD-related complications but also for the detection or verification of technical issues. Within this review the utilization of medical imaging equipment for the diagnosis of technical malfunctions or damages of implanted system components is discussed. A newly developed specialized acoustic imaging method for pump thrombosis detection will also be described along with the most common VAD-related medical complications and their respective imaging methods and the limitations induced by the use of the VAD-system.

  14. Mobile medical image retrieval

    NASA Astrophysics Data System (ADS)

    Duc, Samuel; Depeursinge, Adrien; Eggel, Ivan; Müller, Henning

    2011-03-01

    Images are an integral part of medical practice for diagnosis, treatment planning and teaching. Image retrieval has gained in importance mainly as a research domain over the past 20 years. Both textual and visual retrieval of images are essential. In the process of mobile devices becoming reliable and having a functionality equaling that of formerly desktop clients, mobile computing has gained ground and many applications have been explored. This creates a new field of mobile information search & access and in this context images can play an important role as they often allow understanding complex scenarios much quicker and easier than free text. Mobile information retrieval in general has skyrocketed over the past year with many new applications and tools being developed and all sorts of interfaces being adapted to mobile clients. This article describes constraints of an information retrieval system including visual and textual information retrieval from the medical literature of BioMedCentral and of the RSNA journals Radiology and Radiographics. Solutions for mobile data access with an example on an iPhone in a web-based environment are presented as iPhones are frequently used and the operating system is bound to become the most frequent smartphone operating system in 2011. A web-based scenario was chosen to allow for a use by other smart phone platforms such as Android as well. Constraints of small screens and navigation with touch screens are taken into account in the development of the application. A hybrid choice had to be taken to allow for taking pictures with the cell phone camera and upload them for visual similarity search as most producers of smart phones block this functionality to web applications. Mobile information access and in particular access to images can be surprisingly efficient and effective on smaller screens. Images can be read on screen much faster and relevance of documents can be identified quickly through the use of images contained in

  15. Scintillator requirements for medical imaging

    SciTech Connect

    Moses, William W.

    1999-09-01

    Scintillating materials are used in a variety of medical imaging devices. This paper presents a description of four medical imaging modalities that make extensive use of scintillators: planar x-ray imaging, x-ray computed tomography (x-ray CT), SPECT (single photon emission computed tomography) and PET (positron emission tomography). The discussion concentrates on a description of the underlying physical principles by which the four modalities operate. The scintillator requirements for these systems are enumerated and the compromises that are made in order to maximize imaging performance utilizing existing scintillating materials are discussed, as is the potential for improving imaging performance by improving scintillator properties.

  16. Medical device market in China.

    PubMed

    Boyer, Philip; Morshed, Bashir I; Mussivand, Tofy

    2015-06-01

    With China's growing old-age population and economic presence on the international stage, it has become important to evaluate its domestic and foreign market contribution to medical devices. Medical devices are instruments or apparatuses used in the prevention, rehabilitation, treatment, or knowledge generation with respect to disease or other abnormal conditions. This article provides information drawn from recent publications to describe the current state of the Chinese domestic market for medical devices and to define opportunities for foreign investment potential therein. Recent healthcare reforms implemented to meet rising demand due to an aging and migrating population are having a positive effect on market growth-a global market with a projected growth of 15% per year over the next decade.

  17. Price transparency for medical devices.

    PubMed

    Pauly, Mark V; Burns, Lawton R

    2008-01-01

    Hospital buyers of medical devices contract with manufacturers with market power that sell differentiated products. The medical staff strongly influences hospitals' choice of devices. Sellers have sought to limit disclosure of transaction prices. Policy-makers have proposed legislation mandating disclosure, in the interest of greater transparency. We discuss why a manufacturer might charge different prices to different hospitals, the role that secrecy plays, and the consequences of secrecy versus disclosure. We argue that hospital-physician relationships are key to understanding what manufacturers gain from price discrimination. Price disclosure can catalyze a restructuring of those relationships, which, in turn, can improve hospital bargaining.

  18. Medical Imaging System

    NASA Technical Reports Server (NTRS)

    1991-01-01

    The MD Image System, a true-color image processing system that serves as a diagnostic aid and tool for storage and distribution of images, was developed by Medical Image Management Systems, Huntsville, AL, as a "spinoff from a spinoff." The original spinoff, Geostar 8800, developed by Crystal Image Technologies, Huntsville, incorporates advanced UNIX versions of ELAS (developed by NASA's Earth Resources Laboratory for analysis of Landsat images) for general purpose image processing. The MD Image System is an application of this technology to a medical system that aids in the diagnosis of cancer, and can accept, store and analyze images from other sources such as Magnetic Resonance Imaging.

  19. Recent medical devices for tonsillectomy.

    PubMed

    Sayin, I; Cingi, C

    2012-01-01

    The most frequent and probably the earliest described surgical intervention of ENT field is tonsillectomy. Various methods were described and devices were invented up to now in order to increase safety and decrease time consumption and complications. All new created devices promises lower intraoperative blood loss, intraoperative time, postoperative pain and bleeding. But with their widely use it is seen that they cannot fulfill what they promise. Debate also continues as to which technique yields the best outcome. This study reports a summary for common medical devices which were previously used in tonsillectomy.

  20. Ethics of medical device safety.

    PubMed

    Kriewall, Timothy J

    2008-01-01

    How safe is safe? The design intent of a medical device is to off er maximum flexibility, and low-cost and fail-safe features. Easily said, these requirements are difficult to deliver in a litigious society where performance standards are uncommon. Medical device manufacturers face challenges as they strive to offer the ultimate in product safety and keep the price affordable for the technology deployed, while making the usability of typically complex products common sense for the operator. As microprocessors are able to assist designers in providing intelligent, multifunctional systems, care must be taken during the design process to balance technological ability with intuitive use. The medical device development process requires rigor that is not often taught to biomedical engineers. Ethical product development requires a process that will be described in this paper using as an example the development of a recent cardiopulmonary perfusion system. However, the same techniques are germane to implantable devices such as cochlear implants. All engineering product development requires trade-off decisions considering how much is too much and how much is too little. Biomedical engineering faculty need to present this ethical dilemma to their students and give them the tools to help decide. However, in the final analysis, the operator of any medical product or installer of any medical device holds the primary responsibility for understanding how to use the system or install the implant in normal use as well as emergent or special situations; the technology is his or her backup in performing the medical professionals primary job.

  1. NASA Technology Finds Uses in Medical Imaging

    NASA Image and Video Library

    NASA software has been incorporated into a new medical imaging device that could one day aid in the interpretation of mammograms, ultrasounds, and other medical imagery. The new MED-SEG system, dev...

  2. 78 FR 18233 - Medical Devices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ... procedure, Confidential business information, Medical devices, Medical research, Reporting and recordkeeping..., 876, 878, 880, 882, 884, 886, 888, 890, and 892 Medical Devices; Technical Amendment AGENCY: Food and... Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code...

  3. [Consideration of Mobile Medical Device Regulation].

    PubMed

    Peng, Liang; Yang, Pengfei; He, Weigang

    2015-07-01

    The regulation of mobile medical devices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medical devices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medical devices in China needs to adopt the risk-based method.

  4. Medical Image Databases

    PubMed Central

    Tagare, Hemant D.; Jaffe, C. Carl; Duncan, James

    1997-01-01

    Abstract Information contained in medical images differs considerably from that residing in alphanumeric format. The difference can be attributed to four characteristics: (1) the semantics of medical knowledge extractable from images is imprecise; (2) image information contains form and spatial data, which are not expressible in conventional language; (3) a large part of image information is geometric; (4) diagnostic inferences derived from images rest on an incomplete, continuously evolving model of normality. This paper explores the differentiating characteristics of text versus images and their impact on design of a medical image database intended to allow content-based indexing and retrieval. One strategy for implementing medical image databases is presented, which employs object-oriented iconic queries, semantics by association with prototypes, and a generic schema. PMID:9147338

  5. Image Compression Devices

    NASA Technical Reports Server (NTRS)

    1994-01-01

    The Rice algorithm is a "lossless" compression algorithm; it takes an image or other data that has been broken down into short strings of digital data, then processes each string mathematically to reduce the amount of memory required to store or transmit them. It is particularly useful in medical, scientific or engineering applications where all data must be preserved. Originally developed at Jet Propulsion Laboratory, the technology is marketed by Advanced Hardware Architectures, a company started by a former employee of the NASA Microelectronics Research Center.

  6. [Medical image enhancement: Sharpening].

    PubMed

    Kats, L; Vered, M

    2015-04-01

    Most digital imaging systems provide opportunities for image enhancement operations. These are applied to improve the original image and to make the image more appealing visually. One possible means of enhancing digital radiographic image is sharpening. The purpose of sharpening filters is to improve image quality by removing noise or edge enhancement. Sharpening filters may make the radiographic images subjectively more appealing. But during this process, important radiographic features may disappear while artifacts that simulate pathological process might be generated. Therefore, it is of utmost importance for dentists to be familiar with and aware of the use of image enhancement operations, provided by medical digital imaging programs.

  7. Reducing Risks Associated with Medical Device Misconnections

    MedlinePlus

    ... partners, professional societies, advocacy groups, patients and other stakeholders to reduce the chance of medical device misconnections. ... medical device misconnections; Communicating with patients and other stakeholders to understand the impact of new connector designs. ...

  8. [International progress of unique device identification for medical devices].

    PubMed

    Yang, Wanjuan; Li, Jun; Li, Jingli

    2014-09-01

    Unique Device Identification (UDI) is a hot spot research area in the medical device administration. It comes a breakthrough from International Medical Device Regulators Forum (IMDRF) and government implementation recently. The article reviewed the advancement of IMDRF UDI program, discussed the framework for UDI system, analyzed the implementation of UDI in other countries, put forward some suggestions on the development of medical device coding system in our country.

  9. Feasibility and Diagnostic Accuracy of Point-of-Care Abdominal Sonography by Pocket-Sized Imaging Devices, Performed by Medical Residents.

    PubMed

    Kjesbu, Ingunn E; Laursen, Christian B; Graven, Torbjørn; Holden, Hans Martin; Rømo, Bjørnar; Newton Andersen, Garrett; Mjølstad, Ole Christian; Lassen, Annmarie; Dalen, Håvard

    2017-06-01

    We aimed to study the feasibility and diagnostic performance of bedside ultrasound by examination of the liver, gallbladder, kidneys, and abdominal aorta performed by medical residents with limited experience in ultrasound, on emergency admissions using pocket-sized imaging devices (PSIDs). A total of 199 patients admitted acutely to the medical department at the non-university Levanger Hospital, Norway, during the period from April 4 to June 23, 2011, were consecutively included. Six medical residents, selected by drawing, examined these patients with a PSID at admission. Reference imaging was performed and/or judged at the Department of Radiology. Each resident performed a median of 28 examinations (interquartile range 24-46). Imaging of the kidneys and liver were feasible in 85 and 82% of the cases, and the corresponding values for the gallbladder and abdominal aorta were 79 and 50%, respectively. The sensitivity of medical residents to detect organ pathology with the aid of PSID, ranged between 54% (95% confidence interval [CI]: 29-77%) and 74% (95% CI: 51-88%). Assessment of the aortic dimension showed moderate correlation, with r = 0.38. Examination by PSID by inexperienced residents may allow for early detection of abdominal pathology, but do not appear to be accurate enough to rule out pathology in the abdominal organs. © 2017 by the American Institute of Ultrasound in Medicine.

  10. Medical imaging systems

    DOEpatents

    Frangioni, John V

    2013-06-25

    A medical imaging system provides simultaneous rendering of visible light and diagnostic or functional images. The system may be portable, and may include adapters for connecting various light sources and cameras in open surgical environments or laparascopic or endoscopic environments. A user interface provides control over the functionality of the integrated imaging system. In one embodiment, the system provides a tool for surgical pathology.

  11. Multiregional medical device development: regulatory perspective.

    PubMed

    Tamura, Atsushi; Kutsumi, Hiromu

    2014-04-01

    There are difficulties in conducting worldwide medical device development simultaneously because each country and/or region has their own medical device regulations. However, to aid globalization of the medical device market, and to quickly provide innovative medical devices to patients, attempts have been made to encourage harmonization and convergence of medical device regulations. 'Harmonization by doing' is a bilateral effort from the United States and Japan to develop global clinical trials and address regulatory barriers that may be impediments to timely device approval. The Global Harmonization Task Force (GHTF) was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems. Since 2012, the GHTF has been replaced by the International Medical Device Regulators Forum.

  12. Metrological Reliability of Medical Devices

    NASA Astrophysics Data System (ADS)

    Costa Monteiro, E.; Leon, L. F.

    2015-02-01

    The prominent development of health technologies of the 20th century triggered demands for metrological reliability of physiological measurements comprising physical, chemical and biological quantities, essential to ensure accurate and comparable results of clinical measurements. In the present work, aspects concerning metrological reliability in premarket and postmarket assessments of medical devices are discussed, pointing out challenges to be overcome. In addition, considering the social relevance of the biomeasurements results, Biometrological Principles to be pursued by research and innovation aimed at biomedical applications are proposed, along with the analysis of their contributions to guarantee the innovative health technologies compliance with the main ethical pillars of Bioethics.

  13. [Medical Devices Law for pain therapists].

    PubMed

    Regner, M; Sabatowski, R

    2016-08-01

    Medical Devices Law is a relatively new legal system, which has replaced the Medical Devices Regulations still well-known in Germany. German Medical Devices Law is based on European directives, which are, in turn, incorporated into national law by the Medical Devices Act. The Medical Devices Act is a framework law and covers a number of regulations that address specific topics within Medical Devices Law. In turn, in individual regulations, reference is made to guidelines, recommendations, etc. from other sources that provide detailed technical information on specific topics. Medical Devices Law is a very complex legal system, which needs to be permanently observed due to constant updating and adjustment. In the current article, the design and the structure of the system will be described, but special emphasis will be laid on important problem areas that need to be considered when applying and operating medical products, in this case by pain therapists in particular.

  14. 21 CFR 892.2030 - Medical image digitizer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image digitizer. 892.2030 Section 892.2030 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2030 Medical image digitizer....

  15. 21 CFR 892.2030 - Medical image digitizer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image digitizer. 892.2030 Section 892.2030 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2030 Medical image digitizer....

  16. 21 CFR 892.2030 - Medical image digitizer.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image digitizer. 892.2030 Section 892.2030 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2030 Medical image digitizer....

  17. 21 CFR 892.2030 - Medical image digitizer.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image digitizer. 892.2030 Section 892.2030 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2030 Medical image digitizer....

  18. Characterization of Therapeutic Coatings on Medical Devices

    NASA Astrophysics Data System (ADS)

    Wormuth, Klaus

    Therapeutic coatings on medical devices such as catheters, guide wires, and stents improve biocompatibility by favorably altering the chemical nature of the device/tissue or device/blood interface. Such coatings often minimize tissue damage (reduce friction), decrease chances for blood clot formation (prevent platelet adsorption), and improve the healing response (deliver drugs). Confocal Raman microscopy provides valuable information about biomedical coatings by, for example, facilitating the measurement of the thickness and swelling of frictionreducing hydrogel coatings on catheters and by determining the distribution of drug within a polymer-based drug-eluting coatings on stents. This chapter explores the application of Raman microscopy to the imaging of thin coatings of cross-linked poly(vinyl pyrrolidone) gels, parylene films, mixtures of dexamethasone with various polymethacrylates, and mixtures of rapamycin with hydrolysable (biodegradable) poly(lactide-co-glycolide) polymers. Raman microscopy measures the thickness and swelling of coatings, reveals the degree of mixing of drug and polymer, senses the hydrolysis of biodegradable polymers, and determines the polymorphic forms of drug present within thin therapeutic coatings on medical devices.

  19. 3D medical thermography device

    NASA Astrophysics Data System (ADS)

    Moghadam, Peyman

    2015-05-01

    In this paper, a novel handheld 3D medical thermography system is introduced. The proposed system consists of a thermal-infrared camera, a color camera and a depth camera rigidly attached in close proximity and mounted on an ergonomic handle. As a practitioner holding the device smoothly moves it around the human body parts, the proposed system generates and builds up a precise 3D thermogram model by incorporating information from each new measurement in real-time. The data is acquired in motion, thus it provides multiple points of view. When processed, these multiple points of view are adaptively combined by taking into account the reliability of each individual measurement which can vary due to a variety of factors such as angle of incidence, distance between the device and the subject and environmental sensor data or other factors influencing a confidence of the thermal-infrared data when captured. Finally, several case studies are presented to support the usability and performance of the proposed system.

  20. Handheld ultrasound array imaging device

    NASA Astrophysics Data System (ADS)

    Hwang, Juin-Jet; Quistgaard, Jens

    1999-06-01

    A handheld ultrasound imaging device, one that weighs less than five pounds, has been developed for diagnosing trauma in the combat battlefield as well as a variety of commercial mobile diagnostic applications. This handheld device consists of four component ASICs, each is designed using the state of the art microelectronics technologies. These ASICs are integrated with a convex array transducer to allow high quality imaging of soft tissues and blood flow in real time. The device is designed to be battery driven or ac powered with built-in image storage and cineloop playback capability. Design methodologies of a handheld device are fundamentally different to those of a cart-based system. As system architecture, signal and image processing algorithm as well as image control circuit and software in this device is deigned suitably for large-scale integration, the image performance of this device is designed to be adequate to the intent applications. To elongate the battery life, low power design rules and power management circuits are incorporated in the design of each component ASIC. The performance of the prototype device is currently being evaluated for various applications such as a primary image screening tool, fetal imaging in Obstetrics, foreign object detection and wound assessment for emergency care, etc.

  1. The Universal Medical Device Nomenclature System.

    PubMed

    Gaev, J A

    1996-01-01

    To facilitate access to medical information, ECRI has developed and promulgated a hierarchical medical device nomenclature system containing over 4,800 valid terms and 3,100 cross-references. The Universal Medical Device Nomenclature System (UMDNS) is appropriate for a wide range of applications. It is used world-wide and is available in 5 languages (7 additional translations are in progress).

  2. 78 FR 15877 - Taxable Medical Devices; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... Internal Revenue Service 26 CFR Part 48 RIN 1545-BJ44 Taxable Medical Devices; Correction AGENCY: Internal... certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010 in..., under the paragraph heading ``A. Proposed Regulations'', line 6, the language ``of taxable medical...

  3. 75 FR 16351 - Medical Devices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ..., and 1050 Medical Devices; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending certain medical.... 360hh- 360ss). The Safe Medical Devices Act of 1990 (SMDA) (Public Law 101- 629), transferred the...

  4. The economic evaluation of medical devices: challenges.

    PubMed

    Kingkaew, Pritaporn; Teerawattananon, Yot

    2014-05-01

    While many of the principles that guide the economic evaluation of medical devices are somewhat similar to those that guide the evaluation of other health technologies, most outline a methodology that focuses on pharmaceutical products rather providing specific guidance for medical devices. Given that medical devices use a wide range of technologies and can be used for many purposes, conducting an economic analysis for medical devices is not straightforward. The cost and effectiveness of a given technology may depend on a number of factors. The objective of this paper is to provide a summary of issues that need to be addressed before undertaking an economic evaluation of medical devices and to outline a number of suggested approaches for undertaking an economic evaluation of medical devices.

  5. Intrauterine device (image)

    MedlinePlus

    ... uses copper as the active contraceptive, others use progesterone in a plastic device. IUDs are very effective ... less than 2% chance per year for the progesterone IUD, less than 1% chance per year for ...

  6. Medical device software: defining key terms.

    PubMed

    Pashkov, Vitalii; Gutorova, Nataliya; Harkusha, Andrii

    one of the areas of significant growth in medical devices has been the role of software - as an integral component of a medical device, as a standalone device and more recently as applications on mobile devices. The risk related to a malfunction of the standalone software used within healthcare is in itself not a criterion for its qualification or not as a medical device. It is therefore, necessary to clarify some criteria for the qualification of stand-alone software as medical devices Materials and methods: Ukrainian, European Union, United States of America legislation, Guidelines developed by European Commission and Food and Drug Administration's, recommendations represented by international voluntary group and scientific works. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. the legal regulation of software which is used for medical purpose in Ukraine limited to one definition. In European Union and United States of America were developed and applying special guidelines that help developers, manufactures and end users to difference software on types standing on medical purpose criteria. Software becomes more and more incorporated into medical devices. Developers and manufacturers may not have initially appreciated potential risks to patients and users such situation could have dangerous results for patients or users. It is necessary to develop and adopt the legislation that will intend to define the criteria for the qualification of medical device software and the application of the classification criteria to such software, provide some illustrative examples and step by step recommendations to qualify software as medical device.

  7. [Software version and medical device software supervision].

    PubMed

    Peng, Liang; Liu, Xiaoyan

    2015-01-01

    The importance of software version in the medical device software supervision does not cause enough attention at present. First of all, the effect of software version in the medical device software supervision is discussed, and then the necessity of software version in the medical device software supervision is analyzed based on the discussion of the misunderstanding of software version. Finally the concrete suggestions on software version naming rules, software version supervision for the software in medical devices, and software version supervision scheme are proposed.

  8. Medical Imaging and Infertility.

    PubMed

    Peterson, Rebecca

    2016-11-01

    Infertility affects many couples, and medical imaging plays a vital role in its diagnosis and treatment. Radiologic technologists benefit from having a broad understanding of infertility risk factors and causes. This article describes the typical structure and function of the male and female reproductive systems, as well as congenital and acquired conditions that could lead to a couple's inability to conceive. Medical imaging procedures performed for infertility diagnosis are discussed, as well as common interventional options available to patients. © 2016 American Society of Radiologic Technologists.

  9. Making digital phantoms with spectral and spatial light modulators for quantitative applications of hyperspectral optical medical imaging devices

    NASA Astrophysics Data System (ADS)

    Chon, Bonghwan; Tokumasu, Fuyuki; Lee, Ji Youn; Allen, David W.; Rice, Joseph P.; Hwang, Jeeseong

    2015-03-01

    We present a procedure to generate digital phantoms with a hyperspectral image projector (HIP) consisting of two liquid crystal on silicon (LCoS) spatial light modulators (SLMs). The digital phantoms are 3D image data cubes of the spatial distribution of spectrally resolved abundances of intracellular light-absorbing oxy-hemoglobin molecules in single erythrocytes. Spectrally and spatially resolved image data indistinguishable from the real scene may be used as standards to calibrate image sensors and validate image analysis algorithms for their measurement quality, performance consistency, and inter-laboratory comparisons for quantitative biomedical imaging applications.

  10. Medical device labeling and advertising: an overview.

    PubMed

    Basile, E M; Armentrout, E; Reeves, K N

    1999-01-01

    The Food and Drug Administration (FDA) has the authority under the Federal Food, Drug, and Cosmetic Act (FDCA) to regulate the labeling of all medical devices. This statement, however, is not as simple as it appears. The regulation of medical device labels and labeling, closely linked to the advertisement of medical devices, is a dynamic area, and FDA is struggling to address the new issues that arise daily in this area. This article seeks to: 1) provide the background necessary to understand the current law and FDA's regulation of medical devices; 2) summarize the law and regulations governing medical devices; 3) define "intended use" and explain its importance; and 4) discuss several areas that are of particular interest to FDA, including promotion of uncleared or unapproved devices and uses, Internet promotion, press releases, and comparative claims.

  11. Medical devices and patient safety.

    PubMed

    Mattox, Elizabeth

    2012-08-01

    Errors related to health care devices are not well understood. Nurses in intensive care and progressive care environments can benefit from understanding manufacturer-related error and device-use error, the principles of human factors engineering, and the steps that can be taken to reduce risk of errors related to health care devices.

  12. MEDICAL DEVICE PRICES IN ECONOMIC EVALUATIONS.

    PubMed

    Akpinar, Ilke; Jacobs, Philip; Husereau, Don

    2015-01-01

    Economic evaluations, although not formally used in purchasing decisions for medical devices in Canada, are still being conducted and published. The aim of this study was to examine the way that prices have been included in Canadian economic evaluations of medical devices. We conducted a review of the economic concepts and implications of methods used for economic evaluations of the eleven most implanted medical devices from the Canadian perspective. We found Canadian economic studies for five of the eleven medical devices and identified nineteen Canadian studies. Overall, the device costs were important components of total procedure cost, with an average ratio of 44.1 %. Observational estimates of the device costs were obtained from buyers or sellers in 13 of the 19 studies. Although most of the devices last more than 1 year, standard costing methods for capital equipment was never used. In addition, only eight studies included a sensitivity analysis for the device cost. None of the sensitivity analyses were based on actual price distributions. Economic evaluations are potentially important for policy making, but although they are being conducted, there is no standardized approach for incorporating medical device prices in economic analyses. Our review provides suggestions for improvements in how the prices are incorporated for economic evaluations of medical devices.

  13. 77 FR 72924 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ...This document contains final regulations that provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010 in conjunction with the Patient Protection and Affordable Care Act. The final regulations affect manufacturers, importers, and producers of taxable medical devices.

  14. Imaging and Analytics: The changing face of Medical Imaging

    NASA Astrophysics Data System (ADS)

    Foo, Thomas

    There have been significant technological advances in imaging capability over the past 40 years. Medical imaging capabilities have developed rapidly, along with technology development in computational processing speed and miniaturization. Moving to all-digital, the number of images that are acquired in a routine clinical examination has increased dramatically from under 50 images in the early days of CT and MRI to more than 500-1000 images today. The staggering number of images that are routinely acquired poses significant challenges for clinicians to interpret the data and to correctly identify the clinical problem. Although the time provided to render a clinical finding has not substantially changed, the amount of data available for interpretation has grown exponentially. In addition, the image quality (spatial resolution) and information content (physiologically-dependent image contrast) has also increased significantly with advances in medical imaging technology. On its current trajectory, medical imaging in the traditional sense is unsustainable. To assist in filtering and extracting the most relevant data elements from medical imaging, image analytics will have a much larger role. Automated image segmentation, generation of parametric image maps, and clinical decision support tools will be needed and developed apace to allow the clinician to manage, extract and utilize only the information that will help improve diagnostic accuracy and sensitivity. As medical imaging devices continue to improve in spatial resolution, functional and anatomical information content, image/data analytics will be more ubiquitous and integral to medical imaging capability.

  15. Anti-malware software and medical devices.

    PubMed

    2010-10-01

    Just as much as healthcare information systems, medical devices need protection against cybersecurity threats. Anti-malware software can help safeguard the devices in your facility-but it has limitations and even risks. Find out what steps you can take to manage anti-malware applications in your devices.

  16. Privacy Challenges for Wireless Medical Devices

    SciTech Connect

    Lagesse, Brent J

    2010-01-01

    Implantable medical devices are becoming more pervasive as new technologies increase their reliability and safety. Furthermore, these devices are becoming increasingly reliant on wireless communication for interaction with the device. Such technologies have the potential to leak information that could be utilized by an attacker to threaten the lives of patients. Privacy of patient information is essential; however, this information is not the only privacy issue that must be considered. In this paper, we discuss why information privacy is insufficient for protecting patients from some attacks and how information regarding the presence of individual devices can leak vulnerabilities. Furthermore, we examine existing privacy enhancing algorithms and discuss their applicability to implantable medical devices.

  17. [Information safety test of digital medical device].

    PubMed

    Liu, Jiong

    2014-07-01

    According to the background of the age of big data, the medical devices are informatized, we analyze the safety and efficiency for the information and data of digital medical devices or medical systems, also discussed some test methods. Lack of a suitable standard system of digital medical devices is a big problem both for domain standard and international standard. GB25000.51 is too ambiguous and free for testing, also not very operational. So this paper suggested some test advices and some prospective method. These test methods are helpful for finding the problem and performing the standards. What's more, these methods are famous in the world and used widely in the 3C region but just start in the medical region, which can promote the development of the medical devices.

  18. Medical imaging systems

    SciTech Connect

    Frangioni, John V

    2012-07-24

    A medical imaging system provides simultaneous rendering of visible light and fluorescent images. The system may employ dyes in a small-molecule form that remains in a subject's blood stream for several minutes, allowing real-time imaging of the subject's circulatory system superimposed upon a conventional, visible light image of the subject. The system may also employ dyes or other fluorescent substances associated with antibodies, antibody fragments, or ligands that accumulate within a region of diagnostic significance. In one embodiment, the system provides an excitation light source to excite the fluorescent substance and a visible light source for general illumination within the same optical guide that is used to capture images. In another embodiment, the system is configured for use in open surgical procedures by providing an operating area that is closed to ambient light. More broadly, the systems described herein may be used in imaging applications where a visible light image may be usefully supplemented by an image formed from fluorescent emissions from a fluorescent substance that marks areas of functional interest.

  19. [Comments and suggestions on the medical device standardization system from the view point of medical devices test].

    PubMed

    Yang, Xiaofang; Wang, Chunren; Yang, Zhaopeng; Li, Deyu

    2013-06-01

    Medical device test is a very important step of medical device registration processes and is also a procedure to confirm whether the medical devices comply with applicable standards. The standardization system is imperfect yet in China due to the complexity of medical devices and the specialty of medical device industry. In this circumstance, the medical device standard is not only the important criteria for the medical devices registration, but also an important practical procedure of the medical device registration. This paper reviews the existing questions and also gives some comments and suggestions on the medical device standardization system from the view point of medical device test.

  20. Multimode imaging device

    DOEpatents

    Mihailescu, Lucian; Vetter, Kai M

    2013-08-27

    Apparatus for detecting and locating a source of gamma rays of energies ranging from 10-20 keV to several MeV's includes plural gamma ray detectors arranged in a generally closed extended array so as to provide Compton scattering imaging and coded aperture imaging simultaneously. First detectors are arranged in a spaced manner about a surface defining the closed extended array which may be in the form a circle, a sphere, a square, a pentagon or higher order polygon. Some of the gamma rays are absorbed by the first detectors closest to the gamma source in Compton scattering, while the photons that go unabsorbed by passing through gaps disposed between adjacent first detectors are incident upon second detectors disposed on the side farthest from the gamma ray source, where the first spaced detectors form a coded aperture array for two or three dimensional gamma ray source detection.

  1. 21 CFR 892.2030 - Medical image digitizer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital...-coupled devices. (b) Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.)....

  2. 77 FR 69488 - Medical Devices; Custom Devices; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Devices; Custom Devices; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug...

  3. Digital diagnosis of medical images

    NASA Astrophysics Data System (ADS)

    Heinonen, Tomi; Kuismin, Raimo; Jormalainen, Raimo; Dastidar, Prasun; Frey, Harry; Eskola, Hannu

    2001-08-01

    The popularity of digital imaging devices and PACS installations has increased during the last years. Still, images are analyzed and diagnosed using conventional techniques. Our research group begun to study the requirements for digital image diagnostic methods to be applied together with PACS systems. The research was focused on various image analysis procedures (e.g., segmentation, volumetry, 3D visualization, image fusion, anatomic atlas, etc.) that could be useful in medical diagnosis. We have developed Image Analysis software (www.medimag.net) to enable several image-processing applications in medical diagnosis, such as volumetry, multimodal visualization, and 3D visualizations. We have also developed a commercial scalable image archive system (ActaServer, supports DICOM) based on component technology (www.acta.fi), and several telemedicine applications. All the software and systems operate in NT environment and are in clinical use in several hospitals. The analysis software have been applied in clinical work and utilized in numerous patient cases (500 patients). This method has been used in the diagnosis, therapy and follow-up in various diseases of the central nervous system (CNS), respiratory system (RS) and human reproductive system (HRS). In many of these diseases e.g. Systemic Lupus Erythematosus (CNS), nasal airways diseases (RS) and ovarian tumors (HRS), these methods have been used for the first time in clinical work. According to our results, digital diagnosis improves diagnostic capabilities, and together with PACS installations it will become standard tool during the next decade by enabling more accurate diagnosis and patient follow-up.

  4. Wavelets in medical imaging

    SciTech Connect

    Zahra, Noor e; Sevindir, Huliya A.; Aslan, Zafar; Siddiqi, A. H.

    2012-07-17

    The aim of this study is to provide emerging applications of wavelet methods to medical signals and images, such as electrocardiogram, electroencephalogram, functional magnetic resonance imaging, computer tomography, X-ray and mammography. Interpretation of these signals and images are quite important. Nowadays wavelet methods have a significant impact on the science of medical imaging and the diagnosis of disease and screening protocols. Based on our initial investigations, future directions include neurosurgical planning and improved assessment of risk for individual patients, improved assessment and strategies for the treatment of chronic pain, improved seizure localization, and improved understanding of the physiology of neurological disorders. We look ahead to these and other emerging applications as the benefits of this technology become incorporated into current and future patient care. In this chapter by applying Fourier transform and wavelet transform, analysis and denoising of one of the important biomedical signals like EEG is carried out. The presence of rhythm, template matching, and correlation is discussed by various method. Energy of EEG signal is used to detect seizure in an epileptic patient. We have also performed denoising of EEG signals by SWT.

  5. Wavelets in medical imaging

    NASA Astrophysics Data System (ADS)

    Zahra, Noor e.; Sevindir, Hulya Kodal; Aslan, Zafer; Siddiqi, A. H.

    2012-07-01

    The aim of this study is to provide emerging applications of wavelet methods to medical signals and images, such as electrocardiogram, electroencephalogram, functional magnetic resonance imaging, computer tomography, X-ray and mammography. Interpretation of these signals and images are quite important. Nowadays wavelet methods have a significant impact on the science of medical imaging and the diagnosis of disease and screening protocols. Based on our initial investigations, future directions include neurosurgical planning and improved assessment of risk for individual patients, improved assessment and strategies for the treatment of chronic pain, improved seizure localization, and improved understanding of the physiology of neurological disorders. We look ahead to these and other emerging applications as the benefits of this technology become incorporated into current and future patient care. In this chapter by applying Fourier transform and wavelet transform, analysis and denoising of one of the important biomedical signals like EEG is carried out. The presence of rhythm, template matching, and correlation is discussed by various method. Energy of EEG signal is used to detect seizure in an epileptic patient. We have also performed denoising of EEG signals by SWT.

  6. Anti-thrombotic technologies for medical devices.

    PubMed

    Lavery, Karen S; Rhodes, Candace; Mcgraw, Adam; Eppihimer, Michael J

    2016-08-03

    Thrombosis associated with medical devices may lead to dramatic increases in morbidity, mortality and increased health care costs. Innovative strategies are being developed to reduce this complication and provide a safe biocompatible interface between device and blood. This article aims to describe the biological phenomena underlying device-associated thrombosis, and surveys the literature describing current and developing technologies designed to overcome this challenge. To reduce thrombosis, biomaterials with varying topographical properties and incorporating anti-thrombogenic substances on their surface have demonstrated potential. Overall, there is extensive literature describing technical solutions to reduce thrombosis associated with medical devices, but clinical results are required to demonstrate significant long-term benefits.

  7. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical device data system. 880.6310 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system...

  8. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical device data system. 880.6310 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system...

  9. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical device data system. 880.6310 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system...

  10. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical device data system. 880.6310 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

  11. Medical batteries for external medical devices

    NASA Astrophysics Data System (ADS)

    Passerini, Stefano; Owens, Boone B.

    A miniature 10 mAh, 3.75 V Li-ion battery (button cell) has been developed for external medical application. The miniature cells (0.2 cm 3) show excellent performance in terms of cycle life, energy and power. Life tests have exceeded 2700 cycles at 60% DOD and discharge rates of 1-3 mA. Full discharge tests (100% DOD) have shown very good performance with more than 90% of the capacity delivered at the C-rate. Pulse discharge tests indicated excellent pulse capabilities of up to 100 mA over low-level background currents of 10-100 μA.

  12. Mobile medical device connectivity: real world solutions.

    PubMed

    Pettus, Dan

    2004-01-01

    Mobile medical devices, such as infusion pumps, provide an important therapeutic function. They are also valuable sources of information about treatment patterns at the point of care. However, these mobile devices have been independent islands of valuable information, unable to share the data they gather with other hospital information resources on a real time basis. Although data from these devices can provide significant improvements for medical safety and vital information needed for clinical best practice development, gathering that data poses significant challenges when interfacing with hospital information systems. Mobile medical devices move from place to place as independent actors, raising a series of security and identification issues when they need to be disconnected and reconnected using traditional tethered cable connections. The continuing lack of accepted communications protocol standards, in spite of the concentrated efforts of organizations like the IEEE and the Medical Information Bus (IEEE 1073) to establish them, has made integration into the hospital information system a complex and non-standard task. The rapid spread in availability and adoption of high-speed 802.11 wireless systems in hospitals offers a realistic connectivity solution for mobile medical devices. Inspite of this, the 802.11 standard is still evolving, and current security methods designed for user-based products like PDAs and laptop computers are not ideal for unmanned mobile medical devices because they assume the availability of a human operator to authenticate a wireless session. In the absence of accepted standards, manufacturers have created practical and innovative solutions to support the collection of clinical data from mobile medical devices and the integration of that data with hospital information systems. This paper will explore the potential benefits of integrating mobile medical devices into the hospital information system, and describe the challenges in

  13. Cloud computing in medical imaging.

    PubMed

    Kagadis, George C; Kloukinas, Christos; Moore, Kevin; Philbin, Jim; Papadimitroulas, Panagiotis; Alexakos, Christos; Nagy, Paul G; Visvikis, Dimitris; Hendee, William R

    2013-07-01

    Over the past century technology has played a decisive role in defining, driving, and reinventing procedures, devices, and pharmaceuticals in healthcare. Cloud computing has been introduced only recently but is already one of the major topics of discussion in research and clinical settings. The provision of extensive, easily accessible, and reconfigurable resources such as virtual systems, platforms, and applications with low service cost has caught the attention of many researchers and clinicians. Healthcare researchers are moving their efforts to the cloud, because they need adequate resources to process, store, exchange, and use large quantities of medical data. This Vision 20/20 paper addresses major questions related to the applicability of advanced cloud computing in medical imaging. The paper also considers security and ethical issues that accompany cloud computing.

  14. Using Zigbee to integrate medical devices.

    PubMed

    Frehill, Paul; Chambers, Desmond; Rotariu, Cosmin

    2007-01-01

    Wirelessly enabling Medical Devices such as Vital Signs Monitors, Ventilators and Infusion Pumps allows central data collection. This paper discusses how data from these types of devices can be integrated into hospital systems using wireless sensor networking technology. By integrating devices you are protecting investment and opening up the possibility of networking with similar devices. In this context we present how Zigbee meets our requirements for bandwidth, power, security and mobility. We have examined the data throughputs for various medical devices, the requirement of data frequency, security of patient data and the logistics of moving patients while connected to devices. The paper describes a new tested architecture that allows this data to be seamlessly integrated into a User Interface or Healthcare Information System (HIS). The design supports the dynamic addition of new medical devices to the system that were previously unsupported by the system. To achieve this, the hardware design is kept generic and the software interface for different types of medical devices is well defined. These devices can also share the wireless resources with other types of sensors being developed in conjunction on this project such as wireless ECG (Electrocardiogram) and Pulse-Oximetry sensors.

  15. 78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... Device Single Audit Program International Coalition Pilot Program; Availability AGENCY: Food and Drug... in the Medical Device Single Audit Program International Coalition Pilot Program. The Medical Device Single Audit Program (MDSAP) was designed and developed to ensure a single audit will provide...

  16. [Maintenance and obsolescence of medical devices].

    PubMed

    Ancellin, J

    1999-02-01

    Maintenance of medical devices is either curative, in case of a failure of the device, or preventive. Preventive maintenance (PM) is undertaken either at constant time intervals or when a given parameter crosses a specified limit. The aim of PM is to amend wear from intensive use as well as from ageing. Normally, the modalities of PM are defined by the manufacturer who must anticipate the possible deficiencies of the device. Some manufacturers tend to recommend exaggerated maintenance procedures. Obsolescence of a medical device is defined by one of the following criteria: a) loss of its initial performances; b) development of medical techniques requiring a wider spectrum of performances; c) presence of new devices with improved securities.

  17. Medical devices for the anesthetist: current perspectives

    PubMed Central

    Ingrande, Jerry; Lemmens, Hendrikus JM

    2014-01-01

    Anesthesiologists are unique among most physicians in that they routinely use technology and medical devices to carry out their daily activities. Recently, there have been significant advances in medical technology. These advances have increased the number and utility of medical devices available to the anesthesiologist. There is little doubt that these new tools have improved the practice of anesthesia. Monitoring has become more comprehensive and less invasive, airway management has become easier, and placement of central venous catheters and regional nerve blockade has become faster and safer. This review focuses on key medical devices such as cardiovascular monitors, airway equipment, neuromonitoring tools, ultrasound, and target controlled drug delivery software and hardware. This review demonstrates how advances in these areas have improved the safety and efficacy of anesthesia and facilitate its administration. When applicable, indications and contraindications to the use of these novel devices will be explored as well as the controversies surrounding their use. PMID:24707188

  18. Proposed amendments to the medical devices Directives.

    PubMed

    Donawa, Maria

    2006-01-01

    As 2005 came to a close, the European Commission issued its formal proposal for a Directive amending the medical devices Directives. This article discusses certain aspects of the proposed amendments and encourages readers to review them in their entirety.

  19. Medical Image Analysis Facility

    NASA Technical Reports Server (NTRS)

    1978-01-01

    To improve the quality of photos sent to Earth by unmanned spacecraft. NASA's Jet Propulsion Laboratory (JPL) developed a computerized image enhancement process that brings out detail not visible in the basic photo. JPL is now applying this technology to biomedical research in its Medical lrnage Analysis Facility, which employs computer enhancement techniques to analyze x-ray films of internal organs, such as the heart and lung. A major objective is study of the effects of I stress on persons with heart disease. In animal tests, computerized image processing is being used to study coronary artery lesions and the degree to which they reduce arterial blood flow when stress is applied. The photos illustrate the enhancement process. The upper picture is an x-ray photo in which the artery (dotted line) is barely discernible; in the post-enhancement photo at right, the whole artery and the lesions along its wall are clearly visible. The Medical lrnage Analysis Facility offers a faster means of studying the effects of complex coronary lesions in humans, and the research now being conducted on animals is expected to have important application to diagnosis and treatment of human coronary disease. Other uses of the facility's image processing capability include analysis of muscle biopsy and pap smear specimens, and study of the microscopic structure of fibroprotein in the human lung. Working with JPL on experiments are NASA's Ames Research Center, the University of Southern California School of Medicine, and Rancho Los Amigos Hospital, Downey, California.

  20. Radiation-tolerant imaging device

    DOEpatents

    Colella, Nicholas J.; Kimbrough, Joseph R.

    1996-01-01

    A barrier at a uniform depth for an entire wafer is used to produce imaging devices less susceptible to noise pulses produced by the passage of ionizing radiation. The barrier prevents charge created in the bulk silicon of a CCD detector or a semiconductor logic or memory device from entering the collection volume of each pixel in the imaging device. The charge barrier is a physical barrier, a potential barrier, or a combination of both. The physical barrier is formed by an SiO.sub.2 insulator. The potential barrier is formed by increasing the concentration of majority carriers (holes) to combine with the electron's generated by the ionizing radiation. A manufacturer of CCD imaging devices can produce radiation-tolerant devices by merely changing the wafer type fed into his process stream from a standard wafer to one possessing a barrier beneath its surface, thus introducing a very small added cost to his production cost. An effective barrier type is an SiO.sub.2 layer.

  1. Radiation-tolerant imaging device

    DOEpatents

    Colella, N.J.; Kimbrough, J.R.

    1996-11-19

    A barrier at a uniform depth for an entire wafer is used to produce imaging devices less susceptible to noise pulses produced by the passage of ionizing radiation. The barrier prevents charge created in the bulk silicon of a CCD detector or a semiconductor logic or memory device from entering the collection volume of each pixel in the imaging device. The charge barrier is a physical barrier, a potential barrier, or a combination of both. The physical barrier is formed by an SiO{sub 2} insulator. The potential barrier is formed by increasing the concentration of majority carriers (holes) to combine with the electron`s generated by the ionizing radiation. A manufacturer of CCD imaging devices can produce radiation-tolerant devices by merely changing the wafer type fed into his process stream from a standard wafer to one possessing a barrier beneath its surface, thus introducing a very small added cost to his production cost. An effective barrier type is an SiO{sub 2} layer. 7 figs.

  2. Intrauterine contraceptive devices: MR imaging.

    PubMed

    Mark, A S; Hricak, H

    1987-02-01

    To assess the safety of magnetic resonance (MR) imaging in women who have an intrauterine contraceptive device (IUD) in place, in vitro and in vivo studies were performed at both 0.35 and 1.5 T. Two commonly used IUDs were tested, one all of plastic, the other with a coil of copper wire on it. Specifically, the study assessed possible motion of the IUD in the magnetic field, potential of the IUD to heat up during two spin-echo imaging sequences commonly used in MR imaging of the pelvis (2,000/30 and 60 [repetition time, msec/echo time, msec], and 500/30), and the appearance on MR images of the IUD devices. A retrospective review of MR images of the pelvis in six women who had an IUD in place was also performed. Results show that an IUD does not move under the influence of the magnetic field, does not heat during spin-echo sequences commonly used for pelvic imaging, and does not produce artifacts in vitro or in vivo. Patients with either type of IUD can be safely imaged with MR, and MR images of the pelvis are not degraded by the presence of an IUD.

  3. 77 FR 6028 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

    ...This document contains proposed regulations that provide guidance on the excise tax imposed on the sale of certain medical devices under section 4191 of the Internal Revenue Code, enacted by the Health Care and Education Reconciliation Act of 2010 in conjunction with the Patient Protection and Affordable Care Act. The proposed regulations affect manufacturers, importers, and producers of taxable medical devices. This document also provides a notice of public hearing on these proposed regulations.

  4. Real-time hand-held ultrasound medical-imaging device based on a new digital quadrature demodulation processor.

    PubMed

    Levesque, Philippe; Sawan, Mohamad

    2009-08-01

    A fully hardware-based real-time digital wideband quadrature demodulation processor based on the Hilbert transform is proposed to process ultrasound radio frequency signals. The presented architecture combines 2 finite impulse response (FIR) filters to process in-phase and quadrature signals and includes a piecewise linear approximation architecture that performs the required square root operations. The proposed implementation enables flexibility to support different transducers with its ability to load on-the-fly different FIR filter coefficient sets. The complexity and accuracy of the demodulator processor are analyzed with simulated RF data; a normalized residual sum-of-squares cost function is used for comparison with the Matlab Hilbert function. Three implementations are integrated into a hand-held ultrasound system for experimental accuracy and performance evaluation. Real-time images were acquired from a reference phantom, demonstrating the feasibility of using the presented architecture to perform real-time digital quadrature demodulation of ultrasonic signal echoes. Experimental results show that the implementation, using only 2942 slices and 3 dedicated digital multipliers of a low-cost and low-power field-programmable gate array (FPGA) is accurate relative to a comparable software- based system; axial and lateral resolution of 1 mm and 2 mm, respectively, were obtained with a 12-mm piezoelectric transducer without postprocessing. Because the processing and sampling rates are the same, high-frequency ultrasound signals can be processed as well. For a 15-frame-per-second display, the hand-held ultrasonic imaging-processing core (FPGA, memory) requires only 45 mW (dynamic) when using a 5-MHz single-element piezoelectric transducer.

  5. Residual ethylene oxide in medical devices and device material.

    PubMed

    Lucas, Anne D; Merritt, Katharine; Hitchins, Victoria M; Woods, Terry O; McNamee, Scott G; Lyle, Dan B; Brown, Stanley A

    2003-08-15

    Ethylene oxide (EO) gas is commonly used to sterilize medical devices. The amount of residual EO remaining in a device depends partly on the type and size of polymeric material. A major concern is the amount of residue that may be available in the body. With the use of the method described by AAMI for headspace analysis of EO residues, different polymers and medical devices subjected to different numbers of sterilization cycles were examined. Next, the effect of various extraction conditions and extraction solutions on these polymers and medical devices was evaluated. The results showed different polymers desorb EO differently. One polyurethane (PU 75D) had much higher EO residue than a different polyurethane (PU 80A). Repeated extraction of the PU 75D was necessary to quantify total EO residue levels. Different extraction solutions influence the amount and reproducibility of EO detected, whereas multiple resterilizations showed no difference in amount of residual EO. Bioavailability of EO was estimated by extracting the devices and polymers in water. Comparison of total EO residues to EO that was bioavailable showed no difference for some polymers and devices, while others had an almost eightfold difference. Some standard biocompatibility tests were run on extracts and devices, but no significant effects were observed. Copyright 2003 Wiley Periodicals, Inc.

  6. Successful recruitment for medical device clinical studies.

    PubMed

    Donawa, Maria

    2004-10-01

    Inadequate subject enrollment represents a significant obstacle during a medical device clinical investigation. It can lead to costly delays and jeopardise the success of an entire device development project. This article discusses the importance of devising an effective subject recruitment strategy so that clinical and regulatory requirements can be met.

  7. Handheld Diagnostic Device Delivers Quick Medical Readings

    NASA Technical Reports Server (NTRS)

    2014-01-01

    To monitor astronauts' health remotely, Glenn Research Center awarded SBIR funding to Cambridge, Massachusetts-based DNA Medical Institute, which developed a device capable of analyzing blood cell counts and a variety of medical biomarkers. The technology will prove especially useful in rural areas without easy access to labs.

  8. Leveraging EHR investments through medical device connectivity.

    PubMed

    Witonsky, Peter

    2012-08-01

    There are two primary factors for analyzing the cost of medical device integration: the total cost of ownership and gains in clinician efficiency. When calculating the long-term total cost of ownership, hospitals should consider the original acquisition cost, ongoing support costs, and also look at the incremental cost of adding a new device. In determining clinical efficiency, recent analyses show that medical device integration alleviates the initial negative impact of implementing an electronic health record and improves clinician efficiency by reducing clinicians' overall documentation activities.

  9. Inhibition of bacterial adhesion on medical devices.

    PubMed

    Rodrigues, Lígia R

    2011-01-01

    Microbial infections resulting from bacterial adhesion to biomaterial surfaces have been observed on almost all medical devices. Biofilm infections pose a number of clinical challenges due to their resistance to immune defence mechanisms and antimicrobials, and, regardless of the sophistication of the implant, all medical devices are susceptible to microbial colonisation and infection. Research efforts are currently directed towards eliminating or reducing infection of medical devices. Strategies to prevent biofilm formation include physiochemical modification of the biomaterial surface to create anti-adhesive surfaces, incorporation of antimicrobial agents into medical device polymers, mechanical design alternatives, and release of antibiotics. Nevertheless, the success of these alternatives has been modest, mainly due to the various environments into which devices are placed and the diversity of ways in which organisms can colonise surfaces. Biosurfactants have been reported as a promising strategy as they effectively inhibit bacterial adhesion and retard biofilm formation, and are thus potentially useful as a new generation of anti-adhesive and antimicrobial coatings for medical devices.

  10. Medical ice slurry production device

    DOEpatents

    Kasza, Kenneth E [Palos Park, IL; Oras, John [Des Plaines, IL; Son, HyunJin [Naperville, IL

    2008-06-24

    The present invention relates to an apparatus for producing sterile ice slurries for medical cooling applications. The apparatus is capable of producing highly loaded slurries suitable for delivery to targeted internal organs of a patient, such as the brain, heart, lungs, stomach, kidneys, pancreas, and others, through medical size diameter tubing. The ice slurry production apparatus includes a slurry production reservoir adapted to contain a volume of a saline solution. A flexible membrane crystallization surface is provided within the slurry production reservoir. The crystallization surface is chilled to a temperature below a freezing point of the saline solution within the reservoir such that ice particles form on the crystallization surface. A deflector in the form of a reciprocating member is provided for periodically distorting the crystallization surface and dislodging the ice particles which form on the crystallization surface. Using reservoir mixing the slurry is conditioned for easy pumping directly out of the production reservoir via medical tubing or delivery through other means such as squeeze bottles, squeeze bags, hypodermic syringes, manual hand delivery, and the like.

  11. Medical alert bracelet (image)

    MedlinePlus

    People with diabetes should always wear a medical alert bracelet or necklace that emergency medical workers will ... People with diabetes should always wear a medical alert bracelet or necklace that emergency medical workers will ...

  12. Medical Device Recalls: Examination of Selected Cases

    DTIC Science & Technology

    1989-10-01

    accelerator Device class: 2 Medical specialty: Radiology Brand: Therac - 25 Linear Accelerator Use: Used in clinical (cancer) radiotherapy Premarketing...design recalls.- As wouldl Ne exp~ected, becaulse all (lass 8 (high-risk) dev.ices require prenmarket ap)1O1lmtSt PNMA-dCSigfl r-ecalls ( 25 , or 89...Table 11.4 PMA-Design Recalls by Device Class, Fiscal Years 1983-88 No. oi Device class recalls Percent 2 (medium risk) 3 1 100 3 (high risk) 25 89

  13. Army Medical Imaging System - ARMIS

    DTIC Science & Technology

    1992-08-08

    The Army Medical Imaging System (ARMIS) would use optical data cards, discs and small computers to perform the required functions of image...a filmless medical imaging system based on stimulable x-ray phosphors and optical data cards. Advantages of the system would be elimination of film

  14. Fabricating a hybrid imaging device

    NASA Technical Reports Server (NTRS)

    Wadsworth, Mark (Inventor); Atlas, Gene (Inventor)

    2003-01-01

    A hybrid detector or imager includes two substrates fabricated under incompatible processes. An array of detectors, such as charged-coupled devices, are formed on the first substrate using a CCD fabrication process, such as a buried channel or peristaltic process. One or more charge-converting amplifiers are formed on a second substrate using a CMOS fabrication process. The two substrates are then bonded together to form a hybrid detector.

  15. Application of Stereo-Imaging Technology to Medical Field

    PubMed Central

    Nam, Kyoung Won; Park, Jeongyun; Kim, In Young

    2012-01-01

    Objectives There has been continuous development in the area of stereoscopic medical imaging devices, and many stereoscopic imaging devices have been realized and applied in the medical field. In this article, we review past and current trends pertaining to the application stereo-imaging technologies in the medical field. Methods We describe the basic principles of stereo vision and visual issues related to it, including visual discomfort, binocular disparities, vergence-accommodation mismatch, and visual fatigue. We also present a brief history of medical applications of stereo-imaging techniques, examples of recently developed stereoscopic medical devices, and patent application trends as they pertain to stereo-imaging medical devices. Results Three-dimensional (3D) stereo-imaging technology can provide more realistic depth perception to the viewer than conventional two-dimensional imaging technology. Therefore, it allows for a more accurate understanding and analysis of the morphology of an object. Based on these advantages, the significance of stereoscopic imaging in the medical field increases in accordance with the increase in the number of laparoscopic surgeries, and stereo-imaging technology plays a key role in the diagnoses of the detailed morphologies of small biological specimens. Conclusions The application of 3D stereo-imaging technology to the medical field will help improve surgical accuracy, reduce operation times, and enhance patient safety. Therefore, it is important to develop more enhanced stereoscopic medical devices. PMID:23115737

  16. Application of stereo-imaging technology to medical field.

    PubMed

    Nam, Kyoung Won; Park, Jeongyun; Kim, In Young; Kim, Kwang Gi

    2012-09-01

    There has been continuous development in the area of stereoscopic medical imaging devices, and many stereoscopic imaging devices have been realized and applied in the medical field. In this article, we review past and current trends pertaining to the application stereo-imaging technologies in the medical field. We describe the basic principles of stereo vision and visual issues related to it, including visual discomfort, binocular disparities, vergence-accommodation mismatch, and visual fatigue. We also present a brief history of medical applications of stereo-imaging techniques, examples of recently developed stereoscopic medical devices, and patent application trends as they pertain to stereo-imaging medical devices. Three-dimensional (3D) stereo-imaging technology can provide more realistic depth perception to the viewer than conventional two-dimensional imaging technology. Therefore, it allows for a more accurate understanding and analysis of the morphology of an object. Based on these advantages, the significance of stereoscopic imaging in the medical field increases in accordance with the increase in the number of laparoscopic surgeries, and stereo-imaging technology plays a key role in the diagnoses of the detailed morphologies of small biological specimens. The application of 3D stereo-imaging technology to the medical field will help improve surgical accuracy, reduce operation times, and enhance patient safety. Therefore, it is important to develop more enhanced stereoscopic medical devices.

  17. Electronic medication packaging devices and medication adherence: a systematic review.

    PubMed

    Checchi, Kyle D; Huybrechts, Krista F; Avorn, Jerry; Kesselheim, Aaron S

    2014-09-24

    Medication nonadherence, which has been estimated to affect 28% to 31% of US patients with hypertension, hyperlipidemia, and diabetes, may be improved by electronic medication packaging (EMP) devices (adherence-monitoring devices incorporated into the packaging of a prescription medication). To investigate whether EMP devices are associated with improved adherence and to identify and describe common features of EMP devices. Systematic review of peer-reviewed studies testing the effectiveness of EMP systems in the MEDLINE, EMBASE, PsycINFO, CINAHL, International Pharmaceutical Abstracts, and Sociological Abstracts databases from searches conducted to June 13, 2014, with extraction of associations between the interventions and adherence, as well as other key findings. Each study was assessed for bias using the Cochrane Handbook for Systematic Reviews of Interventions; features of EMP devices and interventions were qualitatively assessed. Thirty-seven studies (32 randomized and 5 nonrandomized) including 4326 patients met inclusion criteria (10 patient interface-only "simple" interventions and 29 "complex" interventions integrated into the health care system [2 qualified for both categories]). Overall, the effect estimates for differences in mean adherence ranged from a decrease of 2.9% to an increase of 34.0%, and the those for differences in the proportion of patients defined as adherent ranged from a decrease of 8.0% to an increase of 49.5%. We identified 5 common EMP characteristics: recorded dosing events and stored records of adherence, audiovisual reminders to cue dosing, digital displays, real-time monitoring, and feedback on adherence performance. Many varieties of EMP devices exist. However, data supporting their use are limited, with variability in the quality of studies testing EMP devices. Devices integrated into the care delivery system and designed to record dosing events are most frequently associated with improved adherence, compared with other

  18. Microscopy imaging device with advanced imaging properties

    DOEpatents

    Ghosh, Kunal; Burns, Laurie; El Gamal, Abbas; Schnitzer, Mark J.; Cocker, Eric; Ho, Tatt Wei

    2016-10-25

    Systems, methods and devices are implemented for microscope imaging solutions. One embodiment of the present disclosure is directed toward an epifluorescence microscope. The microscope includes an image capture circuit including an array of optical sensor. An optical arrangement is configured to direct excitation light of less than about 1 mW to a target object in a field of view of that is at least 0.5 mm.sup.2 and to direct epi-fluorescence emission caused by the excitation light to the array of optical sensors. The optical arrangement and array of optical sensors are each sufficiently close to the target object to provide at least 2.5 .mu.m resolution for an image of the field of view.

  19. Microscopy imaging device with advanced imaging properties

    DOEpatents

    Ghosh, Kunal; Burns, Laurie; El Gamal, Abbas; Schnitzer, Mark J.; Cocker, Eric; Ho, Tatt Wei

    2016-11-22

    Systems, methods and devices are implemented for microscope imaging solutions. One embodiment of the present disclosure is directed toward an epifluorescence microscope. The microscope includes an image capture circuit including an array of optical sensor. An optical arrangement is configured to direct excitation light of less than about 1 mW to a target object in a field of view of that is at least 0.5 mm.sup.2 and to direct epi-fluorescence emission caused by the excitation light to the array of optical sensors. The optical arrangement and array of optical sensors are each sufficiently close to the target object to provide at least 2.5 .mu.m resolution for an image of the field of view.

  20. Microscopy imaging device with advanced imaging properties

    DOEpatents

    Ghosh, Kunal; Burns, Laurie; El Gamal, Abbas; Schnitzer, Mark J.; Cocker, Eric; Ho, Tatt Wei

    2017-04-25

    Systems, methods and devices are implemented for microscope imaging solutions. One embodiment of the present disclosure is directed toward an epifluorescence microscope. The microscope includes an image capture circuit including an array of optical sensor. An optical arrangement is configured to direct excitation light of less than about 1 mW to a target object in a field of view of that is at least 0.5 mm.sup.2 and to direct epi-fluorescence emission caused by the excitation light to the array of optical sensors. The optical arrangement and array of optical sensors are each sufficiently close to the target object to provide at least 2.5 .mu.m resolution for an image of the field of view.

  1. Microscopy imaging device with advanced imaging properties

    SciTech Connect

    Ghosh, Kunal; Burns, Laurie; El Gamal, Abbas; Schnitzer, Mark J.; Cocker, Eric; Ho, Tatt Wei

    2015-11-24

    Systems, methods and devices are implemented for microscope imaging solutions. One embodiment of the present disclosure is directed toward an epifluorescence microscope. The microscope includes an image capture circuit including an array of optical sensor. An optical arrangement is configured to direct excitation light of less than about 1 mW to a target object in a field of view of that is at least 0.5 mm.sup.2 and to direct epi-fluorescence emission caused by the excitation light to the array of optical sensors. The optical arrangement and array of optical sensors are each sufficiently close to the target object to provide at least 2.5 .mu.m resolution for an image of the field of view.

  2. [Medical devices classification: principles and quality management].

    PubMed

    Ventura, M

    2011-09-01

    Medical device market covers a large rank of references and is characterized by a lack of standardization in products naming. Using a specific classification is the first step to ensure a good analysis and a specific follow up of this market. CLADIMED is the classification for medical device used in France and Belgium. It is a five level classification, similar to the Anatomical Therapeutical Chemical classification (ATC) for drugs (WHO). CLADIMED association, gathering users and suppliers, manage this classification. A scientific committee is in charge to guarantee quality and respect of the classification principles. 2011. Published by Elsevier Masson SAS.

  3. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; misleading statements. 801.6... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements. Among representations in the labeling of a device which render such device misbranded is a...

  4. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; misleading statements. 801.6... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements. Among representations in the labeling of a device which render such device misbranded is a...

  5. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; misleading statements. 801.6... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements. Among representations in the labeling of a device which render such device misbranded is a...

  6. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; misleading statements. 801.6... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements. Among representations in the labeling of a device which render such device misbranded is a...

  7. Medical applications for pharmacists using mobile devices.

    PubMed

    Aungst, Timothy Dy

    2013-01-01

    Mobile devices (eg, smartphones, tablet computers) have become ubiquitous and subsequently there has been a growth in mobile applications (apps). Concurrently, mobile devices have been integrated into health care practice due to the availability and quality of medical apps. These mobile medical apps offer increased access to clinical references and point-of-care tools. However, there has been little identification of mobile medical apps suitable for the practice of pharmacy. To address the shortage of recommendations of mobile medical apps for pharmacists in daily practice. Mobile medical apps were identified via the iTunes and Google Play Stores via the "Medical" app categories and key word searches (eg, drug information, medical calculators). In addition, reviews provided by professional mobile medical app review websites were used to identify apps. Mobile medical apps were included if they had been updated in the previous 3 months, were available in the US, used evidence-based information or literature support, had dedicated app support, and demonstrated stability. Exclusion criteria included apps that were not available in English, had advertisement bias, used nonreferenced sources, were available only via an institution-only subscription, and were web-based portals. Twenty-seven mobile apps were identified and reviewed that involved general pharmacy practice, including apps that involved drug references, clinical references, medical calculators, laboratory references, news and continuing medical education, and productivity. Mobile medical apps have a variety of features that are beneficial to pharmacy practice. Individual clinicians should consider several characteristics of these apps to determine which are suitable to incorporate into their daily practice.

  8. Government health policy and the diffusion of new medical devices.

    PubMed Central

    Hillman, B J

    1986-01-01

    The combination of absent financial incentives, aspects of physicians' clinical training, and the uncertainty surrounding the appropriate application of expensive new medical devices have been the most significant factors in promoting their wasteful diffusion and use. This presentation summarizes the forces that have resulted in regulatory and reimbursement initiatives to make more efficient the acquisition and utilization of new medical devices. The case histories of computed tomography (CT) and magnetic resonance imaging (MRI) serve as a paradigm demonstrating why such initiatives have thus far proved ineffectual. More effective would be to abandon distinctions between inpatient and outpatient reimbursement for using new medical devices and to improve the relationship between reimbursement and technology assessment. PMID:3818311

  9. Intelligent distributed medical image management

    NASA Astrophysics Data System (ADS)

    Garcia, Hong-Mei C.; Yun, David Y.

    1995-05-01

    The rapid advancements in high performance global communication have accelerated cooperative image-based medical services to a new frontier. Traditional image-based medical services such as radiology and diagnostic consultation can now fully utilize multimedia technologies in order to provide novel services, including remote cooperative medical triage, distributed virtual simulation of operations, as well as cross-country collaborative medical research and training. Fast (efficient) and easy (flexible) retrieval of relevant images remains a critical requirement for the provision of remote medical services. This paper describes the database system requirements, identifies technological building blocks for meeting the requirements, and presents a system architecture for our target image database system, MISSION-DBS, which has been designed to fulfill the goals of Project MISSION (medical imaging support via satellite integrated optical network) -- an experimental high performance gigabit satellite communication network with access to remote supercomputing power, medical image databases, and 3D visualization capabilities in addition to medical expertise anywhere and anytime around the country. The MISSION-DBS design employs a synergistic fusion of techniques in distributed databases (DDB) and artificial intelligence (AI) for storing, migrating, accessing, and exploring images. The efficient storage and retrieval of voluminous image information is achieved by integrating DDB modeling and AI techniques for image processing while the flexible retrieval mechanisms are accomplished by combining attribute- based and content-based retrievals.

  10. [Medical imaging: its medical economics and recent situation in Japan.].

    PubMed

    Imai, Keiko

    2006-01-01

    Two fields of radiology, medical imaging and radiation therapy, are coded separately in medical fee system, and the health care statistics of 2003 shows that expenditure on the former was 5.2% of the whole medical cost and the latter 0.28%. Introduction of DPC, an abbreviation of Diagnostic Procedure Combination, was carried out in 2003, which was an essential reform of medical fee payment system that have been managed on fee-for-service base throughout, and 22% of beds for acute patients care are under the control of DPC payment in 2006. As medical imaging procedures are basically classified in inclusive payment in DPC system, their accurate statistics cannot be figured out because of the lack of description of individual procedures in DPC bills. Policy-making of medical economics will suffer a great loss from the deficiency of detailed data in published statistics. Important role in clinical diagnoses of CT and MR results an increase of fee paid for them up to more than half of total expenditure on medical imaging. So, dominant reduction of examination fee has been done for MR imaging, especially in 2002, to reduce the total cost of medical imaging. Follows could be featured as major topics of medical imaging in health insurance system, (a) fee is newly assigned for electronic handling of CT-and-MR images, and nuclear medicine, and (b) there is still a mismatch between actual payment and quality of medical facilities. As matters related to medical imaging, the followings should be stressed; (a) numbers of CT and MR units per population are dominantly high among OECD countries, but, those controlled by qualified radiologists are at the average level of those countries, (b) there is a big difference of MR examination quality among medical facilities, and (c) 76% of newly-installed high-end MR units are supplied by foreign industries. Hopefully, there will be an increase in the concern to medical fee payment system and health care cost because they possibly

  11. Global Medical Device Nomenclature: The Concept for Reducing Device-Related Medical Errors

    PubMed Central

    Anand, K; Saini, SK; Singh, BK; Veermaram, C

    2010-01-01

    In the medical device field, there are a number of players, having quite different responsibilities and levels of understanding of the processes, but all with one common interest, that of ensuring the availability of sound medical devices to the general public. To assist in this very important process, there is a need for a common method for describing and identifying these medical devices in an unambiguous manner. The Global Medical Device Nomenclature (GMDN) now provides, for the first time, an international tool for identifying all medical devices, at the generic level, in a meaningful manner that can be understood by all users. Prior to the GMDN, many nomenclature systems existed, all built upon different structures, and used locally or nationally for special purposes, with unusual approaches. These diverse systems, although often workable in their own right, have had no impact on improving the overall situation of providing a common platform, whereby, medical devices could be correctly identified and the related data safely exchanged between the involved parties. Work by standard organizations such as, CEN (European Committee for Standardization) and ISO (International Organization for Standardization), from 1993 to 1996, resulted in a standard that specified a structure for a new nomenclature, for medical devices. In this article we are trying to explain GMDN as the prime method to reduce medical device errors, and to understand the concept of GMDN, to regulate the medical device throughout the globe. Here we also make an attempt to explain various aspects of the GMDN system, such as, the process of development of the GMDN-CEN report, purpose, benefits, and their structural considerations. In addition, there will be an explanation of the coding system, role of the GMDN agency, and their utilization in the unique device identification (UDI) System. Finally, the current area of focus and vision for the future are also mentioned. PMID:21264103

  12. Devices, systems, and methods for imaging

    DOEpatents

    Appleby, David; Fraser, Iain; Watson, Scott

    2008-04-15

    Certain exemplary embodiments comprise a system, which can comprise an imaging plate. The imaging plate can be exposable by an x-ray source. The imaging plate can be configured to be used in digital radiographic imaging. The imaging plate can comprise a phosphor-based image storage device configured to convert an image stored therein into light.

  13. Devices, systems, and methods for imaging

    DOEpatents

    Appleby, David; Fraser, Iain; Watson, Scott

    2008-04-15

    Certain exemplary embodiments comprise a system, which can comprise an imaging plate. The imaging plate can be exposable by an x-ray source. The imaging plate can be configured to be used in digital radiographic imaging. The imaging plate can comprise a phosphor-based image storage device configured to convert an image stored therein into light.

  14. Intravascular foreign bodies: danger of unretrieved fragmented medical devices.

    PubMed

    Tateishi, Minori; Tomizawa, Yasuko

    2009-01-01

    A warning on the danger of unretrieved device fragments and recommendations to mitigate the danger were issued by the Food and Drug Administration in January 2008. The causes of intravascular foreign bodies are classified into three main categories: improper manipulation and usage, device defects, and others, such as patient and anatomical factors. Device failure after long-term use is rarely predicted at the time of approval, since device abnormality is rarely experienced in animal studies and clinical trials conducted during development of the device. Stent fracture due to metal fatigue is one example. Complex complications could occur from simultaneous use of two or more devices with diverse characteristics. The success rate of percutaneous retrieval of intravascular foreign bodies has improved with the advances in commercially available devices. However, the procedure is not always successful and sometimes surgical removal becomes necessary. Appropriate device selection and acquisition of experience in using the device are important. When an intravascular foreign body cannot be retrieved, the risk of complication could be high. Magnetic resonance imaging examination sometimes causes adverse events, including burns due to the heat generated by metal movement. Such information should be correctly recorded. Furthermore, it is necessary to provide patients with adequate information about the characteristics of implanted devices and unretrieved fragments. We reviewed the literature on unretrieved medical device fragments and include articles that describe the Japanese experience.

  15. [Membrane separation technology in medical devices].

    PubMed

    Hu, Xianghua; Dang, Xiyun; Wu, Minyu

    2014-01-01

    Membrane separation technology is a major branch in modern separation technology, which is widely applied in chemical, pharmaceutical and other industries. The purpose of this paper is to introduce principle and the application example of the membrane separation technology in medical devices, to analyse the problems existing in the current application, and to discuss the future development direction.

  16. Review of the Medical Device Directive.

    PubMed

    Donawa, Maria

    2003-03-01

    An effective evaluation of the functioning of the Medical Device (MD) Directive is of the utmost importance and has global significance. This article discusses the official review of the MD Directive, its conclusions, and some of the more important activities resulting from the review.

  17. [Batteries Used in Active Implantable Medical Devices].

    PubMed

    Ma, Bozhi; Hao, Hongwei; Li, Luming

    2015-03-01

    In recent years active implantable medical devices(AIMD) are being developed rapidly. Many battery systems have been developed for different AIMD applications. These batteries have the same requirements which include high safety, reliability, energy density and long service life, discharge indication. History, present and future of batteries used in AIMD are introduced in the article.

  18. Desktop supercomputers. Advance medical imaging.

    PubMed

    Frisiello, R S

    1991-02-01

    Medical imaging tools that radiologists as well as a wide range of clinicians and healthcare professionals have come to depend upon are emerging into the next phase of functionality. The strides being made in supercomputing technologies--including reduction of size and price--are pushing medical imaging to a new level of accuracy and functionality.

  19. Medical imaging 4

    SciTech Connect

    Loew, M.H. )

    1990-01-01

    This book is covered under the following topics: human visual pattern recognition, fractals, rules, and segments, three-dimensional image processing, MRI, MRI and mammography, clinical applications 1, angiography, image processing systems, image processing poster session.

  20. The grays of medical device color additives.

    PubMed

    Seidman, Brenda

    2014-01-01

    The United States' medical device color additive regulations are unknown to some, and confusing to many. This article reviews statutory language on color additives in the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, including the Delaney Clause on carcinogenicity; color additive regulatory language as it relates to medical devices in Title 21 of the Code of Federal Regulations (C.F.R.), Parts 70-82; reports on the Food and Drug Administration's (FDA's) likely current and historical practices in dealing with color additives in medical devices; and speculates on what may have given rise to decades of seemingly ad hoc color additives practices, which may now be difficult to reconstruct and satisfactorily modify. Also addressed is the Center for Devices and Radiological Health's (CDRH's) recent publicly-vetted approach to color additives in Section 7 of its April 2013 draft guidance, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," which the author concludes is a change in the right direction, but which, at least in its current draft form, is not a fix to the CDRH's color additives dilemma. Lastly, the article suggests what the CDRH might consider in further developing a new approach to color additives. Such an approach would treat color additives as if they were any other potentially toxic group of chemicals, and could be fashioned in such a way that the CDRH could still satisfy the broad aspects of Congressional color additives mandates, and.yet be consistent with ISO 10993. In doing this, the CDRH would need to recommend a more directed use of its Quality System Regulation, 21 C.F.R. Part 820, for material and vendor qualification and validation in general; approach Congress for needed statutory changes; or make administrative changes. In order for any approach to be successful, whether it is a new twist on past practices, or an entirely new path forward, the FDA must, to the best of its

  1. [Design and application of implantable medical device information management system].

    PubMed

    Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying

    2013-03-01

    Through the establishment of implantable medical device information management system, with the aid of the regional joint sharing of resources, we further enhance the implantable medical device traceability management level, strengthen quality management, control of medical risk.

  2. Bluetooth Communication for Battery Powered Medical Devices

    NASA Astrophysics Data System (ADS)

    Babušiak, Branko; Borik, Štefan

    2016-01-01

    wireless communication eliminates obtrusive cables associated with wearable sensors and considerably increases patient comfort during measurement and collection of medical data. Wireless communication is very popular in recent years and plays a significant role in telemedicine and homecare applications. Bluetooth technology is one of the most commonly used wireless communication types in medicine. This paper describes the design of a universal wireless communication device with excellent price/performance ratio. The said device is based on the low-cost RN4020 Bluetooth module with Microchip Low-energy Data Profile (MLDP) and due to low-power consumption is especially suitable for the transmission of biological signals (ECG, EMG, PPG, etc.) from wearable medical/personal health devices. A unique USB dongle adaptor was developed for wireless communication via UART interface and power consumption was evaluated under various conditions.

  3. Value-based purchasing of medical devices.

    PubMed

    Obremskey, William T; Dail, Teresa; Jahangir, A Alex

    2012-04-01

    Health care in the United States is known for its continued innovation and production of new devices and techniques. While the intention of these devices is to improve the delivery and outcome of patient care, they do not always achieve this goal. As new technologies enter the market, hospitals and physicians must determine which of these new devices to incorporate into practice, and it is important these devices bring value to patient care. We provide a model of a physician-engaged process to decrease cost and increase review of physician preference items. We describe the challenges, implementation, and outcomes of cost reduction and product stabilization of a value-based process for purchasing medical devices at a major academic medical center. We implemented a physician-driven committee that standardized and utilized evidence-based, clinically sound, and financially responsible methods for introducing or consolidating new supplies, devices, and technology for patient care. This committee worked with institutional finance and administrative leaders to accomplish its goals. Utilizing this physician-driven committee, we provided access to new products, standardized some products, decreased costs of physician preference items 11% to 26% across service lines, and achieved savings of greater than $8 million per year. The implementation of a facility-based technology assessment committee that critically evaluates new technology can decrease hospital costs on implants and standardize some product lines.

  4. Adhesive bonding of medical and implantable devices.

    PubMed

    Tavakoli, S M

    2002-09-01

    Although there are many commercially available medical-grade adhesives, their use for new applications requires detailed investigation. It is also important that as well as the initial joint strength, durability of the bonded components during intended use, including exposure to low and high temperatures, stress, fluids and sterilisation, are investigated. Design of accelerated ageing tests, which can simulate the service environments, is critical in providing realistic durability data. Interpretation of ageing data and lifetime prediction of the joint is essential in assessing the performance of medical devices. Emergence of new types of adhesives as well as further development of precision dispensing and rapid-curing technologies offer many exciting and commercially attractive opportunities for joining medical devices.

  5. Medical device vigilance systems: India, US, UK, and Australia.

    PubMed

    Gupta, Pooja; Janodia, Manthan D; Jagadish, Puralea C; Udupa, Nayanabhirama

    2010-01-01

    The term medical device includes a wide category of products ranging from therapeutic medical devices exerting their effects locally such as tissue cutting, wound covering or propping open clogged arteries, to highly sophisticated computerized medical equipment and diagnostic medical devices. To achieve uniformity among the national medical device regulatory systems and increase the access to safe, effective, and clinically beneficial medical technologies, the Global Harmonization Task Force (GHTF) was conceived in 1992 by five members: European Union, United States, Australia, Japan, and Canada. All regulated countries have clearly defined medical devices, as has the GHTF. Although GHTF has tried to achieve harmonization with respect to medical devices, some differences still exist in the national laws of the countries of GHTF. Further, regulated countries have classified medical devices on the basis of their associated risk. In the Indian regulatory system, medical devices are still considered as drugs. In 2006, the Medical Device Regulation Bill was recommended to consolidate laws for medical devices and to establish the Medical Device Regulatory Authority of India. In addition, medical devices are not classified by any Indian regulatory authority. Although India has moved towards harmonizing its medical device regulations with those of regulated countries, this study aims to identify whether India should have a vigilance system in harmony with those of GHTF or develop its own system for medical devices.

  6. Onboard tagging for smart medical devices.

    PubMed

    Li, Kejia; Warren, Steve

    2011-01-01

    Most medical devices are 'dumb:' their role is to acquire, display, and forward data. They make few if any operational decisions based on those data. Onboard tagging is a means whereby a device can embed information about itself, its data, and the sensibility of those data into its data stream. This diagnostic add-on offers a move toward 'smart' devices that will have the ability to affect changes in operational modes based on onboard contextual decision making, such as decisions to avoid needless wireless transmission of corrupt data. This paper presents a description of three types of onboard tags that relate to device hardware (type I tag), signal statistics (type II tag), and signal viability for the intended application (type III tag). A custom wireless pulse oximeter is presented as a use case to show how type II and III tags that convey photoplethysmogram (PPG) statistics and usability specifiers can be calculated and embedded into the data stream without degrading performance.

  7. Automated medical image segmentation techniques

    PubMed Central

    Sharma, Neeraj; Aggarwal, Lalit M.

    2010-01-01

    Accurate segmentation of medical images is a key step in contouring during radiotherapy planning. Computed topography (CT) and Magnetic resonance (MR) imaging are the most widely used radiographic techniques in diagnosis, clinical studies and treatment planning. This review provides details of automated segmentation methods, specifically discussed in the context of CT and MR images. The motive is to discuss the problems encountered in segmentation of CT and MR images, and the relative merits and limitations of methods currently available for segmentation of medical images. PMID:20177565

  8. Medical hyperspectral imaging: a review.

    PubMed

    Lu, Guolan; Fei, Baowei

    2014-01-01

    Hyperspectral imaging (HSI) is an emerging imaging modality for medical applications, especially in disease diagnosis and image-guided surgery. HSI acquires a three-dimensional dataset called hypercube, with two spatial dimensions and one spectral dimension. Spatially resolved spectral imaging obtained by HSI provides diagnostic information about the tissue physiology, morphology, and composition. This review paper presents an overview of the literature on medical hyperspectral imaging technology and its applications. The aim of the survey is threefold: an introduction for those new to the field, an overview for those working in the field, and a reference for those searching for literature on a specific application.

  9. Medical hyperspectral imaging: a review

    PubMed Central

    Lu, Guolan; Fei, Baowei

    2014-01-01

    Abstract. Hyperspectral imaging (HSI) is an emerging imaging modality for medical applications, especially in disease diagnosis and image-guided surgery. HSI acquires a three-dimensional dataset called hypercube, with two spatial dimensions and one spectral dimension. Spatially resolved spectral imaging obtained by HSI provides diagnostic information about the tissue physiology, morphology, and composition. This review paper presents an overview of the literature on medical hyperspectral imaging technology and its applications. The aim of the survey is threefold: an introduction for those new to the field, an overview for those working in the field, and a reference for those searching for literature on a specific application. PMID:24441941

  10. Automated medical image segmentation techniques.

    PubMed

    Sharma, Neeraj; Aggarwal, Lalit M

    2010-01-01

    Accurate segmentation of medical images is a key step in contouring during radiotherapy planning. Computed topography (CT) and Magnetic resonance (MR) imaging are the most widely used radiographic techniques in diagnosis, clinical studies and treatment planning. This review provides details of automated segmentation methods, specifically discussed in the context of CT and MR images. The motive is to discuss the problems encountered in segmentation of CT and MR images, and the relative merits and limitations of methods currently available for segmentation of medical images.

  11. Power Approaches for Implantable Medical Devices

    PubMed Central

    Ben Amar, Achraf; Kouki, Ammar B.; Cao, Hung

    2015-01-01

    Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health). In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources. PMID:26580626

  12. Power Approaches for Implantable Medical Devices.

    PubMed

    Ben Amar, Achraf; Kouki, Ammar B; Cao, Hung

    2015-11-13

    Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health). In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources.

  13. 76 FR 12973 - Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-09

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory... Medical Devices Advisory Committee. This meeting was announced in the Federal Register of February 7, 2011... meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee would be held on...

  14. Deformable Medical Image Registration: A Survey

    PubMed Central

    Sotiras, Aristeidis; Davatzikos, Christos; Paragios, Nikos

    2013-01-01

    Deformable image registration is a fundamental task in medical image processing. Among its most important applications, one may cite: i) multi-modality fusion, where information acquired by different imaging devices or protocols is fused to facilitate diagnosis and treatment planning; ii) longitudinal studies, where temporal structural or anatomical changes are investigated; and iii) population modeling and statistical atlases used to study normal anatomical variability. In this paper, we attempt to give an overview of deformable registration methods, putting emphasis on the most recent advances in the domain. Additional emphasis has been given to techniques applied to medical images. In order to study image registration methods in depth, their main components are identified and studied independently. The most recent techniques are presented in a systematic fashion. The contribution of this paper is to provide an extensive account of registration techniques in a systematic manner. PMID:23739795

  15. Early technology assessment of new medical devices.

    PubMed

    Pietzsch, Jan B; Paté-Cornell, M Elisabeth

    2008-01-01

    In the United States, medical devices represent an eighty-billion dollar a year market. The U.S. Food and Drug Administration rejects a significant number of applications of devices that reach the investigational stage. The prospects of improving patient condition, as well as firms' profits, are thus substantial, but fraught with uncertainties at the time when investments and design decisions are made. This study presents a quantitative model focused on the risk aspects of early technology assessment, designed to support the decisions of medical device firms in the investment and development stages. The model is based on the engineering risk analysis method involving systems analysis and probability. It assumes use of all evidence available (both direct and indirect) and integrates the information through a linear formula of aggregation of probability distributions. The model is illustrated by a schematic version of the case of the AtrialShaper, a device for the reduction of stroke risk that is currently in the preprototype stage. The results of the modeling provide a more complete description of the evidence base available to support early-stage decisions, thus allowing comparison of alternative designs and management alternatives. The model presented here provides early-stage decision-support to industry, but also benefits regulators and payers in their later assessment of new devices and associated procedures.

  16. MCAT to XCAT: The Evolution of 4-D Computerized Phantoms for Imaging Research: Computer models that take account of body movements promise to provide evaluation and improvement of medical imaging devices and technology.

    PubMed

    Paul Segars, W; Tsui, Benjamin M W

    2009-12-01

    Recent work in the development of computerized phantoms has focused on the creation of ideal "hybrid" models that seek to combine the realism of a patient-based voxelized phantom with the flexibility of a mathematical or stylized phantom. We have been leading the development of such computerized phantoms for use in medical imaging research. This paper will summarize our developments dating from the original four-dimensional (4-D) Mathematical Cardiac-Torso (MCAT) phantom, a stylized model based on geometric primitives, to the current 4-D extended Cardiac-Torso (XCAT) and Mouse Whole-Body (MOBY) phantoms, hybrid models of the human and laboratory mouse based on state-of-the-art computer graphics techniques. This paper illustrates the evolution of computerized phantoms toward more accurate models of anatomy and physiology. This evolution was catalyzed through the introduction of nonuniform rational b-spline (NURBS) and subdivision (SD) surfaces, tools widely used in computer graphics, as modeling primitives to define a more ideal hybrid phantom. With NURBS and SD surfaces as a basis, we progressed from a simple geometrically based model of the male torso (MCAT) containing only a handful of structures to detailed, whole-body models of the male and female (XCAT) anatomies (at different ages from newborn to adult), each containing more than 9000 structures. The techniques we applied for modeling the human body were similarly used in the creation of the 4-D MOBY phantom, a whole-body model for the mouse designed for small animal imaging research. From our work, we have found the NURBS and SD surface modeling techniques to be an efficient and flexible way to describe the anatomy and physiology for realistic phantoms. Based on imaging data, the surfaces can accurately model the complex organs and structures in the body, providing a level of realism comparable to that of a voxelized phantom. In addition, they are very flexible. Like stylized models, they can easily be

  17. Microbattery technologies for miniaturized implantable medical devices.

    PubMed

    Nathan, Menachem

    2010-06-01

    Implanted medical devices (IMDs), in particular neuro-stimulators, drug delivery chips and cochlear implants are undergoing miniaturization. Some of these miniaturized IMDs are "active" in the sense that they require a power source for operation. In most cases, the ideal power source needs to be an implanted battery of dimensions similar to that of the device. The state-of-the-art of battery miniaturization is reviewed with emphasis on novel Li and Li-ion two- and three-dimensional thin-film microbatteries. It is shown that three-dimensional thin-film batteries may provide a solution to the power requirements of miniaturized IMDs.

  18. Open-source hardware for medical devices.

    PubMed

    Niezen, Gerrit; Eslambolchilar, Parisa; Thimbleby, Harold

    2016-04-01

    Open-source hardware is hardware whose design is made publicly available so anyone can study, modify, distribute, make and sell the design or the hardware based on that design. Some open-source hardware projects can potentially be used as active medical devices. The open-source approach offers a unique combination of advantages, including reducing costs and faster innovation. This article compares 10 of open-source healthcare projects in terms of how easy it is to obtain the required components and build the device.

  19. Open-source hardware for medical devices

    PubMed Central

    2016-01-01

    Open-source hardware is hardware whose design is made publicly available so anyone can study, modify, distribute, make and sell the design or the hardware based on that design. Some open-source hardware projects can potentially be used as active medical devices. The open-source approach offers a unique combination of advantages, including reducing costs and faster innovation. This article compares 10 of open-source healthcare projects in terms of how easy it is to obtain the required components and build the device. PMID:27158528

  20. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; expiration of exemptions. 801.127... (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

  1. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; expiration of exemptions. 801.127... (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

  2. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; expiration of exemptions. 801.127... (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

  3. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; expiration of exemptions. 801.127... (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

  4. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; expiration of exemptions. 801.127... (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

  5. 76 FR 45268 - Reprocessing of Reusable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-28

    ... HUMAN SERVICES Food and Drug Administration Reprocessing of Reusable Medical Devices AGENCY: Food and... Administration (FDA) is considering factors affecting the reprocessing of reusable medical devices, including reprocessing quality, device design as it relates to the reprocessing of reusable medical devices, reprocessing...

  6. [The Requirements of Medical Device Market Access in India].

    PubMed

    Qin, Shaoyan; Cui, Tao; Yin, Haisong

    2016-01-01

    This paper introduces the premarket registration procedures and the post market regulatory requirements in India. According to Indian medical device act and related medical regulations on medical device, this is a preliminary discussion on the registration management system to provide referance for foreign medical device to enter India market.

  7. Residuals on medical devices following reprocessing.

    PubMed

    Martiny, H; Floss, H

    2001-08-01

    Micro-organisms may be transmitted by medical devices. A large variety of infectious agents may be involved in infections transmitted by endoscopic procedures. We review a series of examples that demonstrate to what extent micro-organisms can be detected on medical devices and how transmission on to subsequently examined persons due to inadequate reprocessing can occur. Hardly any data are available regarding residuals of process chemicals, although numerous published cases of glutaraldehyde-related colitis demonstrate that this issue requires urgent clarification. A risk of endoscope contamination exists, interalia, if washer-disinfectors are technically defective or are incorrectly operated. In particular, a final rinse water of poor microbiological quality can lead to recontamination of endoscopes.

  8. Model observers in medical imaging research.

    PubMed

    He, Xin; Park, Subok

    2013-10-04

    Model observers play an important role in the optimization and assessment of imaging devices. In this review paper, we first discuss the basic concepts of model observers, which include the mathematical foundations and psychophysical considerations in designing both optimal observers for optimizing imaging systems and anthropomorphic observers for modeling human observers. Second, we survey a few state-of-the-art computational techniques for estimating model observers and the principles of implementing these techniques. Finally, we review a few applications of model observers in medical imaging research.

  9. Electronic medication packaging devices and medication adherence: A systematic review

    PubMed Central

    Checchi, Kyle D.; Huybrechts, Krista F.; Avorn, Jerry; Kesselheim, Aaron S.

    2014-01-01

    Importance Medication non-adherence, which has been estimated to affect 28-31% of US patients with hypertension, hyperlipidemia, and diabetes, may be improved by electronic medication packaging (EMP) devices. Objective To investigate whether EMP devices are associated with improved adherence and to identify and describe common features of EMP devices. Evidence Acquisition We systematically reviewed peer-reviewed studies testing the effectiveness of EMP systems in the MEDLINE, EMBASE, PsycINFO, CINAHL, and International Pharmaceutical Abstracts databases from searches conducted to June 13, 2014. We extracted the associations between the interventions and adherence, as well as other key findings. We assessed each study for bias using the Cochrane Handbook for Systematic Reviews of Interventions. We qualitatively assessed features of EMP devices and interventions. Results 37 studies (32 randomized and 5 non-randomized) including 4,326 patients met review criteria: 10 patient-interface-only “simple” interventions and 29 “complex” interventions integrated into the health care system (2 qualified for both categories). Overall, the effect estimates for mean adherence ranged from -2.9 to 34.0% and the effect estimates for the proportion of patients defined as adherent ranged from -8.0 to 49.5%. We identified 5 common EMP characteristics: recording dosing events and storing a record of adherence, audiovisual reminders to cue dosing, digital displays, real-time monitoring, and providing patients with adherence performance feedback. Conclusion and Relevance Many varieties of EMP exist. However, data supporting their use are limited, with variability in the quality of studies testing EMP devices and evidence of reporting bias. Devices that are integrated into the care delivery system and that are designed to record dosing events are most frequently associated with improved adherence. Higher quality evidence is needed to determine the effect, if any, of these low cost

  10. Ethylene Oxide Gas Sterilization of Medical Devices.

    PubMed

    Shintani, Hideharu

    2017-01-01

     Ethylene oxide gas is an agent in the sterilization of medical devices due to its effectiveness and compatibility with most materials. The advantages and disadvantages, as well as its recommended uses, are explored in this review article. The variables and their relevance on process optimization are described, the types of processing cycles are detailed and emphasis is given to the design and validation of the sterilization process.

  11. Images for medical diagnoses.

    PubMed

    Meyer-Ebrecht, D

    1978-01-01

    Dr. Dietrich Meyer-Ebrecht provides a broad and helpful overview of the many techniques and latest trends in diagnostic imaging. Latest sensing technology is reviewed including: X-ray systems, ultrasound, thermography, radionuclide imaging, endoscopy, and optical methods. Approximate system cost ranges are indicated. This paper examines the technological trends in: sensors, imagers, hardcopy production, computer enhancement, storage, and communication of images. Dr. Meyer-Ebrecht describes three generations of computed tomographic scanners and alternative approaches to three-dimensional imaging. Image storage is presented as a major limitation of present technology. A view of future systems approaches envisions "picture bases" that will complement present data bases of hospital information systems. Integration of latest technology into diagnostic picture information systems will lead to advanced systems.

  12. Charge-coupled device image sensor study

    NASA Technical Reports Server (NTRS)

    1973-01-01

    The design specifications and predicted performance characteristics of a Charge-Coupled Device Area Imager and a Charge-Coupled Device Linear Imager are presented. The Imagers recommended are intended for use in space-borne imaging systems and therefore would meet the requirements for the intended application. A unique overlapping metal electrode structure and a buried channel structure are described. Reasons for the particular imager designs are discussed.

  13. Regenerative implantable medical devices: an overview.

    PubMed

    Yu, Shu-Yang; Li, Fu-Yao; Wang, Hong-Man

    2016-06-01

    To conduct a bibliometric evaluation and trend prediction of English literature on animal-derived regenerative implantable medical devices based on tissue engineering technology. Data identified by a search strategy with eleven combinations of keywords before 1 January, 2014 were downloaded from eight databases on 25 November, 2014. The study analysed publication year, journal preference, authors' geographic location and research topics. Research on animal-derived regenerative implantable medical devices is gradually increasing. The majority of the first authors are from colleges or universities. Approximately one-third of the papers were the result of cooperation of different institutions. The top five productive countries are the United States, China, UK, Germany and Italy. Biomaterials are the main literature source. Bradford's law analysis shows that a core journal area has formed. The active areas of research and future research directions are 'scaffold materials', 'biocompatibility', 'growth factors' and 'extracellular matrix'. Research of animal-derived regenerative implantable medical devices has attracted more and more attention from the academia. But most of the research achievements are generated by a few developed countries. Researchers around the world need to complement each other in knowledge and academic resources by communication and cooperation. © 2016 Health Libraries Group.

  14. Polyimide MEMS actuators for medical imaging

    NASA Astrophysics Data System (ADS)

    Zara, Jason M.; Mills, Patrick; Patterson, Paul

    2005-01-01

    This paper provides an overview of several years of research in the use of polyimide MEMS actuators for medical imaging applications, including high frequency ultrasound and optical coherence tomography (OCT). These scanning devices are microfabricated out of polyimide substrates using conventional integrated circuit technology. The material properties of the polyimide allow very large scan angles to be realized and also allow the resonant frequencies of the structures to be in the appropriate ranges for real-time imaging. The primary application of these probes is endoscopic and catheter-based imaging procedures. The microfabrication enables the creation of very small devices essential for compact imaging probes. In addition, they can be fabricated in bulk, reducing their cost and potentially making them disposable to reduce the cost of patient care and minimize the potential for patient cross-contamination. Several different scanning geometries and actuators have been investigated for imaging applications, including both forward-viewing and side-scanning configurations. Probes that utilize both electrostatic polyimide actuators and piezoelectric bimorphs to mechanically scan the ultrasound or OCT imaging beams will be presented. These probes have been developed for both use in both ultrasound and OCT imaging systems. Medical applications of these probes include the early detection of cancerous and precancerous conditions in the bladder and other mucosal tissues. These imaging probes will allow the physician to visualize the subsurface microstructure of the tissues and detect abnormalities not visible through the use of conventional endoscopic imaging techniques. Prototype devices have been used to image geometric wire phantoms, in vitro porcine tissue, and in vivo subjects. The progress made over the last several years in the development of these polyimide scanning probes will be presented.

  15. Machine Learning for Medical Imaging

    PubMed Central

    Erickson, Bradley J.; Korfiatis, Panagiotis; Akkus, Zeynettin; Kline, Timothy L.

    2017-01-01

    Machine learning is a technique for recognizing patterns that can be applied to medical images. Although it is a powerful tool that can help in rendering medical diagnoses, it can be misapplied. Machine learning typically begins with the machine learning algorithm system computing the image features that are believed to be of importance in making the prediction or diagnosis of interest. The machine learning algorithm system then identifies the best combination of these image features for classifying the image or computing some metric for the given image region. There are several methods that can be used, each with different strengths and weaknesses. There are open-source versions of most of these machine learning methods that make them easy to try and apply to images. Several metrics for measuring the performance of an algorithm exist; however, one must be aware of the possible associated pitfalls that can result in misleading metrics. More recently, deep learning has started to be used; this method has the benefit that it does not require image feature identification and calculation as a first step; rather, features are identified as part of the learning process. Machine learning has been used in medical imaging and will have a greater influence in the future. Those working in medical imaging must be aware of how machine learning works. PMID:28212054

  16. Machine Learning for Medical Imaging.

    PubMed

    Erickson, Bradley J; Korfiatis, Panagiotis; Akkus, Zeynettin; Kline, Timothy L

    2017-01-01

    Machine learning is a technique for recognizing patterns that can be applied to medical images. Although it is a powerful tool that can help in rendering medical diagnoses, it can be misapplied. Machine learning typically begins with the machine learning algorithm system computing the image features that are believed to be of importance in making the prediction or diagnosis of interest. The machine learning algorithm system then identifies the best combination of these image features for classifying the image or computing some metric for the given image region. There are several methods that can be used, each with different strengths and weaknesses. There are open-source versions of most of these machine learning methods that make them easy to try and apply to images. Several metrics for measuring the performance of an algorithm exist; however, one must be aware of the possible associated pitfalls that can result in misleading metrics. More recently, deep learning has started to be used; this method has the benefit that it does not require image feature identification and calculation as a first step; rather, features are identified as part of the learning process. Machine learning has been used in medical imaging and will have a greater influence in the future. Those working in medical imaging must be aware of how machine learning works. (©)RSNA, 2017.

  17. Medical device disinfection by dense carbon dioxide.

    PubMed

    Bertoloni, G; Bertucco, A; Rassu, M; Vezzù, K

    2011-01-01

    The employment of disinfection-sterilisation processes for the re-use of medical devices without negative effects such as the presence of toxic residues, material degradation or other modifications is an important consideration for reducing the costs of surgical and medical procedures. Ethylene oxide is the most commonly used low temperature sterilisation technique in healthcare facilities, but its associated toxicity has reduced interest in this technology for the reprocessing of medical equipment. The aim of this study was to examine the disinfection efficiency of a novel low temperature approach, based on dense carbon dioxide on artificially contaminated catheters. The results obtained demonstrated that this method provided a complete inactivation of all bacteria and yeast strains tested, and that no obvious modifications to the surfaces tested were observed with multiple treatments. Copyright © 2010 The Hospital Infection Society. Published by Elsevier Ltd. All rights reserved.

  18. Compressive sensing in medical imaging

    PubMed Central

    Graff, Christian G.; Sidky, Emil Y.

    2015-01-01

    The promise of compressive sensing, exploitation of compressibility to achieve high quality image reconstructions with less data, has attracted a great deal of attention in the medical imaging community. At the Compressed Sensing Incubator meeting held in April 2014 at OSA Headquarters in Washington, DC, presentations were given summarizing some of the research efforts ongoing in compressive sensing for x-ray computed tomography and magnetic resonance imaging systems. This article provides an expanded version of these presentations. Sparsity-exploiting reconstruction algorithms that have gained popularity in the medical imaging community are studied, and examples of clinical applications that could benefit from compressive sensing ideas are provided. The current and potential future impact of compressive sensing on the medical imaging field is discussed. PMID:25968400

  19. Compressive sensing in medical imaging.

    PubMed

    Graff, Christian G; Sidky, Emil Y

    2015-03-10

    The promise of compressive sensing, exploitation of compressibility to achieve high quality image reconstructions with less data, has attracted a great deal of attention in the medical imaging community. At the Compressed Sensing Incubator meeting held in April 2014 at OSA Headquarters in Washington, DC, presentations were given summarizing some of the research efforts ongoing in compressive sensing for x-ray computed tomography and magnetic resonance imaging systems. This article provides an expanded version of these presentations. Sparsity-exploiting reconstruction algorithms that have gained popularity in the medical imaging community are studied, and examples of clinical applications that could benefit from compressive sensing ideas are provided. The current and potential future impact of compressive sensing on the medical imaging field is discussed.

  20. Medical imaging: the radiation issue.

    PubMed

    Einstein, Andrew J

    2009-06-01

    The collective doses of ionizing radiation to Western populations have risen dramatically in the past three decades. Preliminary data on changes in radiation dose to the US population indicate that this increase has been driven largely by medical imaging, to which cardiovascular imaging modalities-such as nuclear stress testing, invasive coronary angiography, and cardiovascular CT-contribute greatly. Given the putative association between low-dose radiation exposure and cancer risk, which most experts agree is supported by the available evidence, the 'radiation issue' in medical imaging has garnered increasing interest. This opinion piece focuses on changes in the use of and doses from medical imaging, the relationship between radiation dose and cancer risk and the controversy surrounding this subject, and clinical implications of radiation exposure from imaging tests.

  1. 78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under... Medical Device Clinical Studies, Including Certain First in Human Studies; Guidance for Industry and Food... ``Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain...

  2. 76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Device Reporting; Malfunction Reporting Frequency... continue to submit malfunction reports in full compliance with FDA's Medical Device Reporting regulation...

  3. Teaching medical device design using design control.

    PubMed

    May-Newman, Karen; Cornwall, G Bryan

    2012-01-01

    The design of medical devices requires an understanding of a large number of factors, many of which are difficult to teach in the traditional educational format. This subject benefits from using a challenge-based learning approach, which provides focused design challenges requiring students to understand important factors in the context of a specific device. A course was designed at San Diego State University (CA, USA) that applied challenge-based learning through in-depth design challenges in cardiovascular and orthopedic medicine, and provided an immersive field, needs-finding experience to increase student engagement in the process of knowledge acquisition. The principles of US FDA 'design control' were used to structure the students' problem-solving approach, and provide a format for the design documentation, which was the basis of grading. Students utilized a combination of lecture materials, industry guest expertise, texts and readings, and internet-based searches to develop their understanding of the problem and design their solutions. The course was successful in providing a greatly increased knowledge base and competence of medical device design than students possessed upon entering the course.

  4. Medical Device Guidebook: A browser information resource for medical device users.

    PubMed

    Clarkson, Douglas M

    2017-03-01

    A web based information resource - the 'Medical Device Guidebook' - for the enabling of safe use of medical devices is described. Medical devices are described within a 'catalogue' of specific models and information on a specific model is provided within a consistent set of information 'keys'. These include 'user manuals', 'points of caution', 'clinical use framework', 'training/assessment material', 'frequently asked questions', 'authorised user comments' and 'consumables'. The system allows identification of known risk/hazards associated with specific devices, triggered, for example, by national alerts or locally raised safety observations. This provides a mechanism for more effective briefing of equipment users on the associated hazards of equipment. A feature of the system is the inclusion of a specific 'Operational Procedure' for each device, where the lack of this focus is shown in the literature to often be a key factor in equipment misuse and associated patient injury. The 'Guidebook' provides a mechanism for the development of an information resource developed within local clinical networks and encourages a consistent approach to medical device use.

  5. Calibration of imaging luminance measuring devices (ILMD)

    NASA Astrophysics Data System (ADS)

    Liu, Liying; Zheng, Feng; Zhu, Lingxi; Li, Ye; Huan, Kewei; Shi, Xiaoguang

    2015-11-01

    A method of calibration of imaging luminance measuring devices has been studied. By the device-independent color space transformation, the color image by digital camera could be converted to the CIE's absolute color space lab. Then, the calibration model is fitted between ln(L/t) and luminance. At last, luminance image is obtained and the dynamic range of luminance image could be adjusted by shutter speed.

  6. 77 FR 68788 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-16

    ...] Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug... conditions caused by hurricane Sandy. Name of Committee: Neurological Devices Panel of the Medical Devices... Catheter is a 7F multilumen device with two balloons mounted near the distal tip. The proximal end has a...

  7. 76 FR 24495 - Reprocessing of Reusable Medical Devices; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ... HUMAN SERVICES Food and Drug Administration Reprocessing of Reusable Medical Devices; Public Workshop... Medical Devices Workshop.'' The purpose of the workshop is to discuss factors affecting the reprocessing of reusable medical devices and FDA's plans to address the identified issues. This workshop is part...

  8. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; misleading statements. 801.6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading...

  9. Medical imaging V

    SciTech Connect

    Loew, M.H.

    1991-01-01

    This book is covered under the following topics: preprocessing and enhancement 1-3; segmentation, feature extraction, and detection 1-2; hardware and software systems for display; and user interface; MRI; MRI and PET; 3-D; image reconstruction, modeling, description, and coding; and knowledge-based methods.

  10. Medical Imaging Informatics.

    PubMed

    Hsu, William; El-Saden, Suzie; Taira, Ricky K

    2016-01-01

    Imaging is one of the most important sources of clinically observable evidence that provides broad coverage, can provide insight on low-level scale properties, is noninvasive, has few side effects, and can be performed frequently. Thus, imaging data provides a viable observable that can facilitate the instantiation of a theoretical understanding of a disease for a particular patient context by connecting imaging findings to other biologic parameters in the model (e.g., genetic, molecular, symptoms, and patient survival). These connections can help inform their possible states and/or provide further coherent evidence. The field of radiomics is particularly dedicated to this task and seeks to extract quantifiable measures wherever possible. Example properties of investigation include genotype characterization, histopathology parameters, metabolite concentrations, vascular proliferation, necrosis, cellularity, and oxygenation. Important issues within the field include: signal calibration, spatial calibration, preprocessing methods (e.g., noise suppression, motion correction, and field bias correction), segmentation of target anatomic/pathologic entities, extraction of computed features, and inferencing methods connecting imaging features to biological states.

  11. Tracking medical devices to ensure patient safety.

    PubMed

    Beyea, Suzanne C

    2003-01-01

    Registered nurses in perioperative settings and managers of perioperative departments must work together to implement policies and procedures to ensure compliance with these very important federal regulations. If the information is not recorded in the proper manner and shared with the manufacturer, patients' safety is at risk. Without the ability to contact physicians and patients, manufacturers cannot alert individuals appropriately if problems arise with a certain device. Tracking devices in the correct manner ensures that patients can be notified expediently. Nurses and managers should examine their current practices to ensure that they are consistent with federal regulations. A regular assessment should be conducted to ensure that tracking forms are completed in an accurate, timely manner, that permission to release a patient's social security number is obtained, and that the hospital is compliant with the FDA's most up-to-date list of devices that must be tracked. All perioperative staff members must receive education about the tracking process in their particular institution and receive updates when the process or FDA regulations change. Maintain patient safety by ensuring that the medical device tracking process is followed accurately and meets federal regulations.

  12. Hacking medical devices a review - biomed 2013.

    PubMed

    Frenger, Paul

    2013-01-01

    Programmable, implantable and external biomedical devices (such as pacemakers, defibrillators, insulin pumps, pain management pumps, vagus nerve stimulators and others) may be vulnerable to unauthorized access, commonly referred to as “hacking”. This intrusion may lead to compromise of confidential patient data or loss of control of the device itself, which may be deadly. Risks to health from unauthorized access is in addition to hazards from faulty (“buggy”) software or circuitry. Historically, this aspect of medical device design has been underemphasized by both manufacturers and regulatory bodies until recently. However, an insulin pump was employed as a murder weapon in 2001 and successful hacking of an implantable defibrillator was demonstrated in 2008. To remedy these problems, professional groups have announced a variety of design standards and the governmental agencies of several countries have enacted device regulations. In turn, manufacturers have developed new software products and hardware circuits to assist biomedical engineering firms to improve their commercial offerings. In this paper the author discusses these issues, reviewing known problems and zero-day threats, with potential solutions. He outlines his approach to secure software and hardware challenges using the Forth language. A plausible scenario is described in which hacking of an implantable defibrillator by terrorists results in a severe national security threat to the United States.

  13. Medical gamma ray imaging

    DOEpatents

    Osborne, Louis S.; Lanza, Richard C.

    1984-01-01

    A method and apparatus for determining the distribution of a position-emitting radioisotope into an object, the apparatus consisting of a wire mesh radiation converter, an ionizable gas for propagating ionization events caused by electrodes released by the converter, a drift field, a spatial position detector and signal processing circuitry for correlating near-simultaneous ionization events and determining their time differences, whereby the position sources of back-to-back collinear radiation can be located and a distribution image constructed.

  14. Stereoscopic medical imaging collaboration system

    NASA Astrophysics Data System (ADS)

    Okuyama, Fumio; Hirano, Takenori; Nakabayasi, Yuusuke; Minoura, Hirohito; Tsuruoka, Shinji

    2007-02-01

    The computerization of the clinical record and the realization of the multimedia have brought improvement of the medical service in medical facilities. It is very important for the patients to obtain comprehensible informed consent. Therefore, the doctor should plainly explain the purpose and the content of the diagnoses and treatments for the patient. We propose and design a Telemedicine Imaging Collaboration System which presents a three dimensional medical image as X-ray CT, MRI with stereoscopic image by using virtual common information space and operating the image from a remote location. This system is composed of two personal computers, two 15 inches stereoscopic parallax barrier type LCD display (LL-151D, Sharp), one 1Gbps router and 1000base LAN cables. The software is composed of a DICOM format data transfer program, an operation program of the images, the communication program between two personal computers and a real time rendering program. Two identical images of 512×768 pixcels are displayed on two stereoscopic LCD display, and both images show an expansion, reduction by mouse operation. This system can offer a comprehensible three-dimensional image of the diseased part. Therefore, the doctor and the patient can easily understand it, depending on their needs.

  15. Architectures and Devices for Millimeter Wave Imaging

    DTIC Science & Technology

    2009-02-01

    Architectures and Devices for Millimeter Wave Imaging by David A. Wikner , Joseph N. Mait, and Mark Mirotznik ARL-TR-4733 February 2009...4733 February 2009 Architectures and Devices for Millimeter Wave Imaging David A. Wikner and Joseph N. Mait Sensors and Electron Devices...PROGRAM ELEMENT NUMBER 5d. PROJECT NUMBER 5e. TASK NUMBER 6. AUTHOR(S) David A. Wikner , Joseph N. Mait, and Mark Mirotznik 5f. WORK UNIT NUMBER

  16. Radiofrequency identification and medical devices: the regulatory framework on electromagnetic compatibility. Part I: medical devices.

    PubMed

    Censi, Federica; Mattei, Eugenio; Triventi, Michele; Bartolini, Pietro; Calcagnini, Giovanni

    2012-05-01

    Radiofrequency identification (RFID) technology has acheived significant success and has penetrated into various areas of healthcare. Several RFID-based applications are used in various modalities with the ultimate aim of improving patient care. When a wireless technology is used in a healthcare environment, attention must be paid to the potential risks deriving from its use; one of the most important being electromagnetic interference with medical devices. In this paper, the regulatory framework concerning the electromagnetic compatibility between RFID and medical devices is analyzed to understand whether and how the application of the current standards allows for the effective control of the risks of electromagnetic interference.

  17. The new collaborative path in medical device development: the medical device innovation consortium.

    PubMed

    Kampfrath, Thomas; Cotten, Steven W

    2013-10-01

    The United States medical device market is the world's largest with over $100 billion in sales in 2011. Despite robust industry growth, the efficiency of the FDA approval process for moderate-risk (Class II) and high-risk devices (Class III) requiring 510(k) submission or pre-market approval (PMA) has been criticized. Recently, the FDA's Center for Devices and Radiological Health (CDRH) announced the creation of a Medical Device Innovation Consortium (MDIC), a public-private partnership (PPP) to share knowledge in regulatory science. Overarching goals include creating a forum for the exchange of ideas among the FDA, industry, and non-profit entities; providing monetary investments for project proposals prioritized by key working groups; and developing tools that support cost effective innovation, data-driven methodology, and implementation strategies. Clinical chemists and clinical laboratory scientists have several unique opportunities to contribute to the MDIC. These laboratory professionals have invaluable experience with the real-life performance of a variety of medical devices and their expertise can recognize unmet needs and contribute towards the acceleration of device development.

  18. 75 FR 875 - Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-06

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on New Contrast Imaging Indication... availability of a guidance for industry entitled ``New Contrast Imaging Indication Considerations for Devices..., FDA agreed to publish guidance for medical imaging devices for use with imaging contrast agents...

  19. 75 FR 14170 - Medical Device Epidemiology Network: Developing Partnership Between the Center for Devices and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-24

    ... HUMAN SERVICES Food and Drug Administration Medical Device Epidemiology Network: Developing Partnership... public workshop entitled ``Medical Device Epidemiology Network (MDEpiNet): Developing Partnership Between... to facilitate discussion among FDA and academic researchers with expertise in epidemiology and...

  20. Health economics of medical devices: opportunities and challenges.

    PubMed

    Simoens, Steven

    2008-01-01

    Expenditure on medical devices is substantial and is expected to grow in the future. This Editorial draws attention to health economic issues surrounding medical devices. To this effect, opportunities and challenges involved in the economic analysis of the market structure of medical device sectors and in the economic evaluation of medical devices are identified. Markets for medical devices tend to be fragmented and suffer from a lack of transparency and competition. In response to this, there is extensive government intervention in many developed countries with a view to keeping down prices, restricting public reimbursement and promoting an efficient use of medical devices. Studies are called for that evaluate and compare country approaches towards regulating medical device markets with a view to informing medical-device policies. Whereas economic evaluation of medicines is well established, and is used to inform pricing and reimbursement decisions in many developed countries, this is less the case for medical devices. There is a need for economic evaluations of medical devices with a view to demonstrating their cost effectiveness. In addition, countries need to implement frameworks for the assessment of new and emerging medical devices with a view to taking pricing and reimbursement decisions.

  1. Integrated Microbatteries for Implantable Medical Devices

    NASA Technical Reports Server (NTRS)

    Whitacre, Jay; West, William

    2008-01-01

    Integrated microbatteries have been proposed to satisfy an anticipated need for long-life, low-rate primary batteries, having volumes less than 1 mm3, to power electronic circuitry in implantable medical devices. In one contemplated application, such a battery would be incorporated into a tubular hearing-aid device to be installed against an eardrum. This device is based on existing tube structures that have already been approved by the FDA for use in human ears. As shown in the figure, the battery would comprise a single cell at one end of the implantable tube. A small volume of Li-based primary battery cathode material would be compacted and inserted in the tube near one end, followed by a thin porous separator, followed by a pressed powder of a Li-containing alloy. Current-collecting wires would be inserted, with suitably positioned insulators to prevent a short circuit. The battery would contain a liquid electrolyte consisting of a Li-based salt in an appropriate solvent. Hermetic seals would be created by plugging both ends with a waterproof polymer followed by deposition of parylene.

  2. Software as a medical device: regulatory critical issues.

    PubMed

    Pelayo, Sylvia; Bras Da Costa, Sabrina; Leroy, Nicolas; Loiseau, Séverine; Beuscart-Zephir, Marie-Catherine

    2013-01-01

    The revised Medical Device Directive has been adopted by the EU in 2010. A major change is that software for certain purposes is now considered a medical device. This entails that a new view needs to be developed on the design, development, evaluation and post-market surveillance of medical software that meets the definition of a medical device. This paper identifies some issues at stake and discusses them.

  3. 76 FR 50485 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the Medical... Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. This meeting was announced... July 14, 2011, FDA announced that a meeting of the Obstetrics and Gynecology Devices Panel of...

  4. 77 FR 42503 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-19

    ... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  5. 75 FR 72832 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  6. 78 FR 77688 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  7. 78 FR 20328 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ... HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY: Food and Drug Administration, HHS... Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee scheduled for April...

  8. 75 FR 44273 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... HUMAN SERVICES Food and Drug Administration Radiological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Radiological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  9. 77 FR 61768 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-11

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the Medical... onset. The CoAxia NeuroFlo Catheter is a 7F multi-lumen device with two balloons mounted near the distal...

  10. Implantable photonic devices for improved medical treatments.

    PubMed

    Sheinman, Victor; Rudnitsky, Arkady; Toichuev, Rakhmanbek; Eshiev, Abdyrakhman; Abdullaeva, Svetlana; Egemkulov, Talantbek; Zalevsky, Zeev

    2014-01-01

    An evolving area of biomedical research is related to the creation of implantable units that provide various possibilities for imaging, measurement, and the monitoring of a wide range of diseases and intrabody phototherapy. The units can be autonomic or built-in in some kind of clinically applicable implants. Because of specific working conditions in the live body, such implants must have a number of features requiring further development. This topic can cause wide interest among developers of optical, mechanical, and electronic solutions in biomedicine. We introduce preliminary clinical trials obtained with an implantable pill and devices that we have developed. The pill and devices are capable of applying in-body phototherapy, low-level laser therapy, blue light (450 nm) for sterilization, and controlled injection of chemicals. The pill is also capable of communicating with an external control box, including the transmission of images from inside the patient’s body. In this work, our pill was utilized for illumination of the sinus-carotid zone in dog and red light influence on arterial pressure and heart rate was demonstrated. Intrabody liver tissue laser ablation and nanoparticle-assisted laser ablation was investigated. Sterilization effect of intrabody blue light illumination was applied during a maxillofacial phlegmon treatment.

  11. Implantable photonic devices for improved medical treatments

    NASA Astrophysics Data System (ADS)

    Sheinman, Victor; Rudnitsky, Arkady; Toichuev, Rakhmanbek; Eshiev, Abdyrakhman; Abdullaeva, Svetlana; Egemkulov, Talantbek; Zalevsky, Zeev

    2014-10-01

    An evolving area of biomedical research is related to the creation of implantable units that provide various possibilities for imaging, measurement, and the monitoring of a wide range of diseases and intrabody phototherapy. The units can be autonomic or built-in in some kind of clinically applicable implants. Because of specific working conditions in the live body, such implants must have a number of features requiring further development. This topic can cause wide interest among developers of optical, mechanical, and electronic solutions in biomedicine. We introduce preliminary clinical trials obtained with an implantable pill and devices that we have developed. The pill and devices are capable of applying in-body phototherapy, low-level laser therapy, blue light (450 nm) for sterilization, and controlled injection of chemicals. The pill is also capable of communicating with an external control box, including the transmission of images from inside the patient's body. In this work, our pill was utilized for illumination of the sinus-carotid zone in dog and red light influence on arterial pressure and heart rate was demonstrated. Intrabody liver tissue laser ablation and nanoparticle-assisted laser ablation was investigated. Sterilization effect of intrabody blue light illumination was applied during a maxillofacial phlegmon treatment.

  12. Energy sources and their development for application in medical devices.

    PubMed

    Rasouli, Mahdi; Phee, Louis Soo Jay

    2010-09-01

    Electronic medical devices have become an indispensable part of modern healthcare. Currently, a wide variety of electronic medical devices are being used to monitor physiological parameters of the body, perform therapy and supplement or even entirely replace complex biological functions. Cardiac pacemakers, cardioverter-defibrillators and cochlear implants are a few examples of such medical devices. Proper functionality of these devices relies heavily on the continuous supply of a sufficient amount of electricity to them. In this sense, a reliable, safe and convenient method for the provision of energy is very crucial. Various approaches have been developed to fulfil the divergent and challenging energy requirements of medical devices. In this article, we present a brief overview of the energy requirements of medical devices and review the existing and emerging energy sources for application in these devices, particularly wearable and implantable devices.

  13. FDA Benchmark Medical Device Flow Models for CFD Validation.

    PubMed

    Malinauskas, Richard A; Hariharan, Prasanna; Day, Steven W; Herbertson, Luke H; Buesen, Martin; Steinseifer, Ulrich; Aycock, Kenneth I; Good, Bryan C; Deutsch, Steven; Manning, Keefe B; Craven, Brent A

    Computational fluid dynamics (CFD) is increasingly being used to develop blood-contacting medical devices. However, the lack of standardized methods for validating CFD simulations and blood damage predictions limits its use in the safety evaluation of devices. Through a U.S. Food and Drug Administration (FDA) initiative, two benchmark models of typical device flow geometries (nozzle and centrifugal blood pump) were tested in multiple laboratories to provide experimental velocities, pressures, and hemolysis data to support CFD validation. In addition, computational simulations were performed by more than 20 independent groups to assess current CFD techniques. The primary goal of this article is to summarize the FDA initiative and to report recent findings from the benchmark blood pump model study. Discrepancies between CFD predicted velocities and those measured using particle image velocimetry most often occurred in regions of flow separation (e.g., downstream of the nozzle throat, and in the pump exit diffuser). For the six pump test conditions, 57% of the CFD predictions of pressure head were within one standard deviation of the mean measured values. Notably, only 37% of all CFD submissions contained hemolysis predictions. This project aided in the development of an FDA Guidance Document on factors to consider when reporting computational studies in medical device regulatory submissions. There is an accompanying podcast available for this article. Please visit the journal's Web site (www.asaiojournal.com) to listen.

  14. Implementation of the medical device directives in Italy.

    PubMed

    Donawa, Maria E

    2002-06-01

    Medical device manufacturers marketing their products in Italy, or planning to do so, need to be aware of any national requirements such as those concerning the registration of manufacturers and devices and language requirements that may apply to their products. This article provides an update on the implementation of the European Directives for medical devices in Italy.

  15. Physician-industry cooperation in the medical device industry.

    PubMed

    Chatterji, Aaron K; Fabrizio, Kira R; Mitchell, Will; Schulman, Kevin A

    2008-01-01

    Anecdotal evidence suggests that innovative medical devices often arise from physicians' inventive activity, but no studies have documented the extent of such physician-engaged innovation. This paper uses patent data and the American Medical Association Physician Masterfile to provide evidence that physicians contribute to medical device innovation, accounting for almost 20 percent of approximately 26,000 medical device patents filed in the United States during 1990-1996. Moreover, two measures indicate that physician patents had more influence on subsequent inventive activity than nonphysician patents. This finding supports the maintenance of an open environment for physician-industry collaboration in the medical device discovery process.

  16. Resolution enhancement in medical ultrasound imaging

    PubMed Central

    Ploquin, Marie; Basarab, Adrian; Kouamé, Denis

    2015-01-01

    Abstract. Image resolution enhancement is a problem of considerable interest in all medical imaging modalities. Unlike general purpose imaging or video processing, for a very long time, medical image resolution enhancement has been based on optimization of the imaging devices. Although some recent works purport to deal with image postprocessing, much remains to be done regarding medical image enhancement via postprocessing, especially in ultrasound imaging. We face a resolution improvement issue in the case of medical ultrasound imaging. We propose to investigate this problem using multidimensional autoregressive (AR) models. Noting that the estimation of the envelope of an ultrasound radio frequency (RF) signal is very similar to the estimation of classical Fourier-based power spectrum estimation, we theoretically show that a domain change and a multidimensional AR model can be used to achieve super-resolution in ultrasound imaging provided the order is estimated correctly. Here, this is done by means of a technique that simultaneously estimates the order and the parameters of a multidimensional model using relevant regression matrix factorization. Doing so, the proposed method specifically fits ultrasound imaging and provides an estimated envelope. Moreover, an expression that links the theoretical image resolution to both the image acquisition features (such as the point spread function) and a postprocessing feature (the AR model) order is derived. The overall contribution of this work is threefold. First, it allows for automatic resolution improvement. Through a simple model and without any specific manual algorithmic parameter tuning, as is used in common methods, the proposed technique simply and exclusively uses the ultrasound RF signal as input and provides the improved B-mode as output. Second, it allows for the a priori prediction of the improvement in resolution via the knowledge of the parametric model order before actual processing. Finally, to achieve

  17. Resolution enhancement in medical ultrasound imaging.

    PubMed

    Ploquin, Marie; Basarab, Adrian; Kouamé, Denis

    2015-01-01

    Image resolution enhancement is a problem of considerable interest in all medical imaging modalities. Unlike general purpose imaging or video processing, for a very long time, medical image resolution enhancement has been based on optimization of the imaging devices. Although some recent works purport to deal with image postprocessing, much remains to be done regarding medical image enhancement via postprocessing, especially in ultrasound imaging. We face a resolution improvement issue in the case of medical ultrasound imaging. We propose to investigate this problem using multidimensional autoregressive (AR) models. Noting that the estimation of the envelope of an ultrasound radio frequency (RF) signal is very similar to the estimation of classical Fourier-based power spectrum estimation, we theoretically show that a domain change and a multidimensional AR model can be used to achieve super-resolution in ultrasound imaging provided the order is estimated correctly. Here, this is done by means of a technique that simultaneously estimates the order and the parameters of a multidimensional model using relevant regression matrix factorization. Doing so, the proposed method specifically fits ultrasound imaging and provides an estimated envelope. Moreover, an expression that links the theoretical image resolution to both the image acquisition features (such as the point spread function) and a postprocessing feature (the AR model) order is derived. The overall contribution of this work is threefold. First, it allows for automatic resolution improvement. Through a simple model and without any specific manual algorithmic parameter tuning, as is used in common methods, the proposed technique simply and exclusively uses the ultrasound RF signal as input and provides the improved B-mode as output. Second, it allows for the a priori prediction of the improvement in resolution via the knowledge of the parametric model order before actual processing. Finally, to achieve the

  18. Scaling device for photographic images

    NASA Technical Reports Server (NTRS)

    Rivera, Jorge E. (Inventor); Youngquist, Robert C. (Inventor); Cox, Robert B. (Inventor); Haskell, William D. (Inventor); Stevenson, Charles G. (Inventor)

    2005-01-01

    A scaling device projects a known optical pattern into the field of view of a camera, which can be employed as a reference scale in a resulting photograph of a remote object, for example. The device comprises an optical beam projector that projects two or more spaced, parallel optical beams onto a surface of a remotely located object to be photographed. The resulting beam spots or lines on the object are spaced from one another by a known, predetermined distance. As a result, the size of other objects or features in the photograph can be determined through comparison of their size to the known distance between the beam spots. Preferably, the device is a small, battery-powered device that can be attached to a camera and employs one or more laser light sources and associated optics to generate the parallel light beams. In a first embodiment of the invention, a single laser light source is employed, but multiple parallel beams are generated thereby through use of beam splitting optics. In another embodiment, multiple individual laser light sources are employed that are mounted in the device parallel to one another to generate the multiple parallel beams.

  19. Medical device integration: CIOs must bridge the digital divide between devices and electronic medical records.

    PubMed

    Raths, David

    2009-02-01

    To get funding approved for medical device integration, ClOs suggest focusing on specific patient safety or staff efficiency pain points. Organizations that make clinical engineering part of their IT team report fewer chain-of-command issues. It also helps IT people understand the clinical goals because the engineering people have been working closely with clinicians for years. A new organization has formed to work on collaboration between clinical engineers and IT professionals. For more information, go to www.ceitcollaboration.org. ECRI Institute has written a guide to handling the convergence of medical technology and hospital networks. Its "Medical Technology for the IT Professional: An Essential Guide for Working in Today's Healthcare Setting" also details how IT professionals can assist hospital technology planning and acquisition, and provide ongoing support for IT-based medical technologies. For more information, visit www.ecri.org/ITresource.

  20. Education and training in regulatory science for medical device development.

    PubMed

    Sakuma, Ichiro

    2013-01-01

    Regulatory science can be defined as the science aimed at the optimal introduction into society of new products of science, such as discovered substances and new scientific tools and technologies as well as knowledge and information. In addition to engineering researches that create novel medical devices, scientific methods for evaluating efficacy, safety and quality of medical devices are necessary to enable rational and scientific evaluation of the device in device approval process. Engineers and medical doctors involving research and development of novel medical devices are required to have basic knowledge on medical device safety standard, medical device regulation, and relevant methodologies. In Japan, several graduate schools in Japan have started educational programs on regulatory sciences in collaboration of Pharmaceuticals and Medical Devices Agency (PMDA), Japan. In 2012, program for researches for development of evaluation guidelines for novel medical device products started where personnel exchanges between academic researches institutes and PMDA. Example of these programs will be introduced in the presentation and its impact on improvement of medical device research and development process will be discussed.

  1. Contextual medical-image viewer

    NASA Astrophysics Data System (ADS)

    Moreno, Ramon A.; Furuie, Sergio S.

    2004-04-01

    One of the greatest difficulties of dealing with medical images is their distinct characteristics, in terms of generation process and noise that requires different forms of treatment for visualization and processing. Besides that, medical images are only a compounding part of the patient"s history, which should be accessible for the user in an understandable way. Other factors that can be used to enhance the user capability and experience are: the computational power of the client machine; available knowledge about the case; if the access is local or remote and what kind of user is accessing the system (physician, nurse, administrator, etc...). These information compose the context of an application and should define its behavior during execution time. In this article, we present the architecture of a viewer that takes into account the contextual information that is present at the moment of execution. We also present a viewer of X-Ray Angiographic images that uses contextual information about the client's hardware and the kind of user to, if necessary, reduce the image size and hide demographic information of the patient. The proposed architecture is extensible, allowing the inclusion of new tools and viewers, being adaptive along time to the evolution of the medical systems.

  2. Home Healthcare Medical Devices: A Checklist

    MedlinePlus

    ... your device and follow them for: - cleaning - replacing batteries, filters - protecting your device (e.g. keep food ... after-hour phone numbers. * If appropriate, keep extra batteries for your device. - Know how to replace them. ...

  3. Novel gaseous detectors for medical imaging

    NASA Astrophysics Data System (ADS)

    Danielsson, M.; Fonte, P.; Francke, T.; Iacobaeus, C.; Ostling, J.; Peskov, V.

    2004-02-01

    We have developed and successfully tested prototypes of two new types of gaseous detectors for medical imaging purposes. The first one is called the Electronic Portal Imaging Device (EPID). It is oriented on monitoring and the precise alignment of the therapeutic cancer treatment beam (pulsed gamma radiation) with respect to the patient's tumor position. The latest will be determined from an X-ray image of the patient obtained in the time intervals between the gamma pulses. The detector is based on a "sandwich" of hole-type gaseous detectors (GEM and glass microcapillary plates) with metallic gamma and X-ray converters coated with CsI layers. The second detector is an X-ray image scanner oriented on mammography and other radiographic applications. It is based on specially developed by us high rate RPCs that are able to operate at rates of 10 5 Hz/mm 2 with a position resolution better than 50 μm at 1 atm. The quality of the images obtained with the latest version of this device were in most cases more superior than those obtained from commercially available detectors.

  4. Image Processing in Medical Microscopy

    PubMed Central

    Preston, Kendall

    1986-01-01

    Full automation in medical microscopy has been accomplished in the field of clinical determination of the white blood cell differential count. Manufacture of differential counting microscopes commenced in 1974, and approximately 1,000 of these robots are now in the field. They analyze images of human white blood cells, red blood cells, and platelets at the global rate of approximately 100,000 slides per day. This incredible throughout represents automated image analysis and pattern recognition at the rate of 5 billion images per year and represents a major accomplishments in the application of machine vision in medicine. In other areas, such as cytology and cytogenetics, automated computer vision is still in the research phase. This paper discusses the state of the art in blood smear analysis automation and in other related areas including multi-resolution microscopy where images are currently being generated over a 64:1 magnification containing from one-quarter megapixel to one gigapixel in full color.

  5. MEDEMAS -Medical Device Management and Maintenance System Architecture

    NASA Astrophysics Data System (ADS)

    Dogan, Ülkü Balcı; Dogan, Mehmet Ugur; Ülgen, Yekta; Özkan, Mehmed

    In the proposed study, a medical device maintenance management system (MEDEMAS) is designed and implemented which provides a data pool of medical devices, the maintenance protocols and other required information for these devices. The system also contains complete repair and maintenance history of a specific device. MEDEMAS creates optimal maintenance schedule for devices and enables the service technician to carry out and report maintenance/repair processes via remote access. Thus predicted future failures are possible to prevent or minimize. Maintenance and repair is essential for patient safety and proper functioning of the medical devices, as it prevents performance decrease of the devices, deterioration of the equipment, and detrimental effects on the health of a patient, the user or other interacting people. The study aims to make the maintenance process more accurate, more efficient, faster and easier to manage and organize; and much less confusing. The accumulated history of medical devices and maintenance personnel helps efficient facility planning.

  6. An update on mobile phones interference with medical devices.

    PubMed

    Mahmoud Pashazadeh, Ali; Aghajani, Mahdi; Nabipour, Iraj; Assadi, Majid

    2013-10-01

    Mobile phones' electromagnetic interference with medical devices is an important issue for the medical safety of patients who are using life-supporting medical devices. This review mainly focuses on mobile phones' interference with implanted medical devices and with medical equipment located in critical areas of hospitals. A close look at the findings reveals that mobile phones may adversely affect the functioning of medical devices, and the specific effect and the degree of interference depend on the applied technology and the separation distance. According to the studies' findings and the authors' recommendations, besides mitigating interference, using mobile phones at a reasonable distance from medical devices and developing technology standards can lead to their effective use in hospital communication systems.

  7. Metrology and Standards Needs for Some Categories of Medical Devices

    PubMed Central

    Chiao, J. C.; Goldman, Julian M.; Heck, David A.; Kazanzides, Peter; Peine, William J.; Stiehl, James B.; Yen, Dwight; Dagalakis, Nicholas G.

    2008-01-01

    With rapid advances in meso-, micro- and nano-scale technology devices and electronics, a new generation of advanced medical devices is emerging, which promises medical treatment that is less invasive and more accurate, automated, and effective. We examined the technological and economic status of five categories of medical devices. A set of metrology needs is identified for each of these categories and suggestions are made to address them. PMID:27096115

  8. Image display device in digital TV

    DOEpatents

    Choi, Seung Jong

    2006-07-18

    Disclosed is an image display device in a digital TV that is capable of carrying out the conversion into various kinds of resolution by using single bit map data in the digital TV. The image display device includes: a data processing part for executing bit map conversion, compression, restoration and format-conversion for text data; a memory for storing the bit map data obtained according to the bit map conversion and compression in the data processing part and image data inputted from an arbitrary receiving part, the receiving part receiving one of digital image data and analog image data; an image outputting part for reading the image data from the memory; and a display processing part for mixing the image data read from the image outputting part and the bit map data converted in format from the a data processing part. Therefore, the image display device according to the present invention can convert text data in such a manner as to correspond with various resolution, carry out the compression for bit map data, thereby reducing the memory space, and support text data of an HTML format, thereby providing the image with the text data of various shapes.

  9. Medical imaging, PACS, and imaging informatics: retrospective.

    PubMed

    Huang, H K

    2014-01-01

    Historical reviews of PACS (picture archiving and communication system) and imaging informatics development from different points of view have been published in the past (Huang in Euro J Radiol 78:163-176, 2011; Lemke in Euro J Radiol 78:177-183, 2011; Inamura and Jong in Euro J Radiol 78:184-189, 2011). This retrospective attempts to look at the topic from a different angle by identifying certain basic medical imaging inventions in the 1960s and 1970s which had conceptually defined basic components of PACS guiding its course of development in the 1980s and 1990s, as well as subsequent imaging informatics research in the 2000s. In medical imaging, the emphasis was on the innovations at Georgetown University in Washington, DC, in the 1960s and 1970s. During the 1980s and 1990s, research and training support from US government agencies and public and private medical imaging manufacturers became available for training of young talents in biomedical physics and for developing the key components required for PACS development. In the 2000s, computer hardware and software as well as communication networks advanced by leaps and bounds, opening the door for medical imaging informatics to flourish. Because many key components required for the PACS operation were developed by the UCLA PACS Team and its collaborative partners in the 1980s, this presentation is centered on that aspect. During this period, substantial collaborative research efforts by many individual teams in the US and in Japan were highlighted. Credits are due particularly to the Pattern Recognition Laboratory at Georgetown University, and the computed radiography (CR) development at the Fuji Electric Corp. in collaboration with Stanford University in the 1970s; the Image Processing Laboratory at UCLA in the 1980s-1990s; as well as the early PACS development at the Hokkaido University, Sapporo, Japan, in the late 1970s, and film scanner and digital radiography developed by Konishiroku Photo Ind. Co. Ltd

  10. [Realization of DICOM medical image compression technology].

    PubMed

    Wang, Chenxi; Wang, Quan; Ren, Haiping

    2013-05-01

    This paper introduces the implement method of DICOM medical image compression technology, The image part of DICOM files are extracted and converted to BMP format. The non-image information in DICOM file are stored into the text. When the final image of JPEG standard and non-image information are encapsulated to DICOM format images, it realizes the compression of medical image, which is beneficial to the image storage and transmission.

  11. Little Black Boxes: Noncardiac Implantable Electronic Medical Devices and Their Anesthetic and Surgical Implications.

    PubMed

    Srejic, Una; Larson, Paul; Bickler, Philip E

    2017-07-01

    Implanted electronic medical devices. or stimulators such as pacemakers and nerve stimulators have grown enormously in diversity and complexity over recent decades. The function and potential interaction of these devices with the perioperative environment is of increasing concern for anesthesiologists and surgeons. Because of the innate electromagnetic environment of the hospital (operating room, gastrointestinal procedure suite, and imaging suite), implanted device malfunction, reprogramming, or destruction may occur and cause physical harm (including nerve injury, blindness, deafness, burn, stroke, paralysis, or coma) to the patient. It is critical for the anesthesiologist and surgeon to be aware of the function and interaction of implanted devices, both with other implanted devices and procedures (such as magnetic resonance imaging and cardioversion) in the hospital environment. Because of these interactions, it is imperative that proper device function is assessed when the surgical procedure is complete. This review article will discuss these important issues for 12 different types of "little black boxes," or noncardiac implantable electronic medical devices.

  12. Evaluation of oral medication delivery devices provided by community pharmacies.

    PubMed

    Honey, Brooke L; Condren, Michelle; Phillips, Christina; Votruba, Allyson

    2013-05-01

    Oral liquids remain common medication dosage forms used for patients who have difficulty swallowing. However, liquids require a delivery device and thus have been linked to medication administration errors. This study identified medication delivery devices available at pharmacies. Delivery devices were obtained from area pharmacies and analyzed for units of measurement, abbreviations, and largest/smallest measurable volume. A total of 58 devices were collected from 22 pharmacies. All devices were marked with mL, and 79% were additionally marked in teaspoons. The 5-mL syringe was the only device dispensed at 14% of locations. Other devices included the dosing spoon, dropper, and cup. The largest measurable volume was 30 mL, whereas the smallest was 0.01 mL, with significant variability among devices. A more consistent approach in prescribing units of measurement is needed. Prescribing in milliliters is an optimal choice because of the accessibility of measuring devices containing this measurement.

  13. 77 FR 7589 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the Medical... Stent System with Gateway PTA Balloon Catheter for the treatment of intracranial arterial stenosis. FDA...

  14. 75 FR 41986 - Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 814 RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on Pediatric Subpopulations That Suffer... available pediatric medical device information as a part of premarket approval applications, requests...

  15. 76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Immunology Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Immunology Devices Panel of the Medical...

  16. 78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-08

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Microbiology Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Microbiology Devices Panel of the Medical...

  17. The value of diagnostic medical imaging.

    PubMed

    Bradley, Don; Bradley, Kendall E

    2014-01-01

    Diagnostic medical imaging has clear clinical utility, but it also imposes significant costs on the health care system. This commentary reviews the factors that drive the cost of medical imaging, discusses current interventions, and suggests possible future courses of action.

  18. Home Use Devices: How to Prepare for and Handle Power Outages for Medical Devices That Require Electricity

    MedlinePlus

    ... Handle Power Outages for Medical Devices that Require Electricity Center for De CDRH vices and Rad lth ... Handle Power Outages for Medical Devices that Require Electricity As a home medical device user, it is ...

  19. Medical device reporting: electronic submission requirements. Final rule.

    PubMed

    2014-02-14

    The Food and Drug Administration (FDA) is revising its postmarket medical device reporting regulation and making technical corrections. This final rule requires device manufacturers and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs), to the Agency in an electronic format that FDA can process, review, and archive. Mandatory electronic reporting will improve the Agency's process for collecting and analyzing postmarket medical device adverse event information. Electronic reporting is also available to user facilities, but this rule permits user facilities to continue to submit written reports to FDA. This final rule also identifies changes to the content of required MDRs to reflect reprocessor information collected on the Form FDA 3500A as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

  20. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine... Licensing Policy § 597.511 In-kind donations of medicine, medical devices, and medical services. (a... medicine, medical devices, and medical services to the Palestinian Authority Ministry of Health,...

  1. Gallium-68 in Medical Imaging.

    PubMed

    Martiniova, Lucia; Palatis, Louis De; Etchebehere, Elba; Ravizzini, Gregory

    2016-01-01

    Over the past several years, Positron Emission Tomography (PET) imaging agents labeled with ;68Gallium (68Ga) have undergone a significant increase in clinical utilization. 68Ga is conveniently produced from a germanium-68/gallium-68 (68Ge/68Ga) generator. Because of the compact size and ease of use of the generator, 68Ga labeled compounds may be more cost-effective than PET radioisotopes that are cyclotron-produced. The convenient half-life of 68Ga (T1/2=68 min) provides sufficient radioactivity for various PET imaging applications, while delivering acceptable radiation doses to patients. This chapter summarizes the emerging clinical utilization of 68Ga-based radiotracers in medical imaging. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  2. Information Processing in Medical Imaging Meeting (IPMI)

    DTIC Science & Technology

    1993-09-30

    Information Processing in Medical Imaging - Meeting (IPMI) F49620-93-1-0352 6. AUTHOR(S) Professor Harrison H. Barrett 7. PERFORMING ORGANIZATION NAME(S) AND...distribution unlimited. Final Report of 1993 Information Processing in Medical Imaging Meeting The 1993 Information Processing in Medical Imaging (IPMI...that the extracted information is correct? Although the emphasis of the meeting was clearly on medical imaging , the techniques and issues discussed

  3. Archimedes, an Archive of Medical Images

    PubMed Central

    Tahmoush, Dave; Samet, Hanan

    2006-01-01

    We present a medical image and medical record database for the storage, research, transmission, and evaluation of medical images. Medical images from any source that supports the DICOM standard can be stored and accessed, as well as associated analysis and annotations. Retrieval is based on patient info, date, doctor’s annotations, features in the images, or a spatial combination. This database supports the secure transmission of sensitive data for tele-medicine and follows all HIPPA regulations. PMID:17238733

  4. Archimedes, an archive of medical images.

    PubMed

    Tahmoush, Dave; Samet, Hanan

    2006-01-01

    We present a medical image and medical record database for the storage, research, transmission, and evaluation of medical images. Medical images from any source that supports the DICOM standard can be stored and accessed, as well as associated analysis and annotations. Retrieval is based on patient info, date, doctor's annotations, features in the images, or a spatial combination. This database supports the secure transmission of sensitive data for tele-medicine and follows all HIPPA regulations.

  5. Certain aspects on medical devices software law regulation.

    PubMed

    Pashkov, Vitalii; Harkusha, Andrii

    some kind of easiness of entry in creating software products on various computing platforms has led to such products being made available perhaps without due consideration of potential risks to users and patients and the most valuable reason for this have been lack of regulatory clarity. Some key points on legal regulation of abovementioned sphere is a base of this study. Ukrainian legislation, European Union`s Guidelines on the qualification and classification of standalone software; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices that works in United States of America. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. in accordance with Ukrainian legislation, software that has a medical purpose could be a medical device. Ukrainian legislation which is established on European Union Medical Devices Directives divide all medical devices on classes. But there aren't any special recommendations or advices on classifications for software medical devices in Ukraine. It is necessary to develop and adopt guidelines on the qualification and classification of medical device software in Ukraine especially considering the harmonization of Ukrainian legislation with the EU legislation, develop special rules for the application of the national mark of conformity for medical device software and defined the « responsible organization » for the medical device software approval process.

  6. Regulatory approval of new medical devices: cross sectional study.

    PubMed

    Marcus, Hani J; Payne, Christopher J; Hughes-Hallett, Archie; Marcus, Adam P; Yang, Guang-Zhong; Darzi, Ara; Nandi, Dipankar

    2016-05-20

     To investigate the regulatory approval of new medical devices.  Cross sectional study of new medical devices reported in the biomedical literature.  PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval.  Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article."  Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device.  5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be "substantially equivalent" to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published.  We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  7. The regulation of cognitive enhancement devices: extending the medical model

    PubMed Central

    Maslen, Hannah; Douglas, Thomas; Cohen Kadosh, Roi; Levy, Neil; Savulescu, Julian

    2014-01-01

    This article presents a model for regulating cognitive enhancement devices (CEDs). Recently, it has become very easy for individuals to purchase devices which directly modulate brain function. For example, transcranial direct current stimulators are increasingly being produced and marketed online as devices for cognitive enhancement. Despite posing risks in a similar way to medical devices, devices that do not make any therapeutic claims do not have to meet anything more than basic product safety standards. We present the case for extending existing medical device legislation to cover CEDs. Medical devices and CEDs operate by the same or similar mechanisms and pose the same or similar risks. This fact coupled with the arbitrariness of the line between treatment and enhancement count in favour of regulating these devices in the same way. In arguing for this regulatory model, the paper highlights potential challenges to its implementation, and suggests solutions. PMID:25243073

  8. 77 FR 66847 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-07

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... remaining pre-Amendment Class III devices. These systems typically consist of a treatment table, pressure...

  9. 75 FR 35495 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory... should have normal gonioscopic anatomy and a visually significant cataract eligible...

  10. 76 FR 7220 - Medical Device Innovation Initiative; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

    ...The Food and Drug Administration (FDA) is announcing the availability of a document for public comment entitled ``Medical Device Innovation Initiative'' (the report). The report proposes potential actions for FDA's Center for Devices and Radiological Health (CDRH) to facilitate the development, assessment, and regulatory review of innovative medical...

  11. Cybersecurity and the Medical Device Product Development Lifecycle.

    PubMed

    Jones, Richard W; Katzis, Konstantinos

    2017-01-01

    Protecting connected medical devices from evolving cyber related threats, requires a continuous lifecycle approach whereby cybersecurity is integrated within the product development lifecycle and both complements and re-enforces the safety risk management processes therein. This contribution reviews the guidance relating to medical device cybersecurity within the product development lifecycle.

  12. Informatics in radiology: Efficiency metrics for imaging device productivity.

    PubMed

    Hu, Mengqi; Pavlicek, William; Liu, Patrick T; Zhang, Muhong; Langer, Steve G; Wang, Shanshan; Place, Vicki; Miranda, Rafael; Wu, Teresa Tong

    2011-01-01

    Acute awareness of the costs associated with medical imaging equipment is an ever-present aspect of the current healthcare debate. However, the monitoring of productivity associated with expensive imaging devices is likely to be labor intensive, relies on summary statistics, and lacks accepted and standardized benchmarks of efficiency. In the context of the general Six Sigma DMAIC (design, measure, analyze, improve, and control) process, a World Wide Web-based productivity tool called the Imaging Exam Time Monitor was developed to accurately and remotely monitor imaging efficiency with use of Digital Imaging and Communications in Medicine (DICOM) combined with a picture archiving and communication system. Five device efficiency metrics-examination duration, table utilization, interpatient time, appointment interval time, and interseries time-were derived from DICOM values. These metrics allow the standardized measurement of productivity, to facilitate the comparative evaluation of imaging equipment use and ongoing efforts to improve efficiency. A relational database was constructed to store patient imaging data, along with device- and examination-related data. The database provides full access to ad hoc queries and can automatically generate detailed reports for administrative and business use, thereby allowing staff to monitor data for trends and to better identify possible changes that could lead to improved productivity and reduced costs in association with imaging services. © RSNA, 2011.

  13. Processing of medical images using Maple

    NASA Astrophysics Data System (ADS)

    Toro Betancur, V.

    2013-05-01

    Maple's Image Tools package was used to process medical images. The results showed clearer images and records of its intensities and entropy. The medical images of a rhinocerebral mucormycosis patient, who was not early diagnosed, were processed and analyzed using Maple's tools, which showed, in a clearer way, the affected parts in the perinasal cavities.

  14. Extraction and stability of ethylene oxide residue in medical devices.

    PubMed

    Lucas, Anne D; Stratmeyer, Melvin E

    2008-01-01

    Ethylene oxide (EO) gas is commonly used to sterilize medical devices. A major concern is the amount of residue that may remain on or in the device and be available in the body. Some standards (ASTMF619 and ISO 10993-12) recommend using two different extraction solutions (one polar, one nonpolar), for sample preparation prior to testing medical devices. However, ISO 10993-7 recommends water to process medical devices to determine EO residual levels. To address this, EO residual levels were examined in different extraction solutions. EO residual levels from devices and materials extracted with different solutions were evaluated. Results from this study indicate little difference between extraction solutions of water, cell culture media, and serum (less than 30% difference). Given the increased cost and increased background noise of media or serum over water, using only water to process medical devices and materials for EO residues appears adequate.

  15. Towards sustainable design for single-use medical devices.

    PubMed

    Hanson, Jacob J; Hitchcock, Robert W

    2009-01-01

    Despite their sophistication and value, single-use medical devices have become commodity items in the developed world. Cheap raw materials along with large scale manufacturing and distribution processes have combined to make many medical devices more expensive to resterilize, package and restock than to simply discard. This practice is not sustainable or scalable on a global basis. As the petrochemicals that provide raw materials become more expensive and the global reach of these devices continues into rapidly developing economies, there is a need for device designs that take into account the total life-cycle of these products, minimize the amount of non-renewable materials consumed and consider alternative hybrid reusable / disposable approaches. In this paper, we describe a methodology to perform life cycle and functional analyses to create additional design requirements for medical devices. These types of sustainable approaches can move the medical device industry even closer to the "triple bottom line"--people, planet, profit.

  16. Micro- and Macrointegration Profiles for Medical Devices and Medical IT Systems.

    PubMed

    Pahontu, Raluca; Merzweiler, Angela; Schneider, Gerd; Bergh, Björn

    2015-01-01

    Collecting, saving, and providing patient data are essential processes of documentation in a hospital. Many IT systems have evolved to provide solutions in this area. The automatic transfer of medical device data to these information systems is a new challenge for hospital IT systems. Some vendors are focused on the integration of medical IT systems and medical devices. They provide great solutions with magnificent features. Nevertheless, those integration solutions are proprietary and isolated, limiting the operator's selection of his medical devices and medical IT systems. Standardizing communication processes within the operating room and between medical devices and medical IT systems brings benefits for both patient and hospital staff. This work identifies and proposes micro- and macrointegration profiles as a basis for new IHE Integration Profiles for both medical IT systems and medical devices of the operating room.

  17. Model-based engineering for medical-device software.

    PubMed

    Ray, Arnab; Jetley, Raoul; Jones, Paul L; Zhang, Yi

    2010-01-01

    This paper demonstrates the benefits of adopting model-based design techniques for engineering medical device software. By using a patient-controlled analgesic (PCA) infusion pump as a candidate medical device, the authors show how using models to capture design information allows for i) fast and efficient construction of executable device prototypes ii) creation of a standard, reusable baseline software architecture for a particular device family, iii) formal verification of the design against safety requirements, and iv) creation of a safety framework that reduces verification costs for future versions of the device software. 1.

  18. Laser focus compensating sensing and imaging device

    DOEpatents

    Vann, C.S.

    1993-08-31

    A laser focus compensating sensing and imaging device permits the focus of a single focal point of different frequency laser beams emanating from the same source point. In particular it allows the focusing of laser beam originating from the same laser device but having differing intensities so that a low intensity beam will not convert to a higher frequency when passing through a conversion crystal associated with the laser generating device. The laser focus compensating sensing and imaging device uses a Cassegrain system to fold the lower frequency, low intensity beam back upon itself so that it will focus at the same focal point as a high intensity beam. An angular tilt compensating lens is mounted about the secondary mirror of the Cassegrain system to assist in alignment. In addition cameras or CCD's are mounted with the primary mirror to sense the focused image. A convex lens is positioned co-axial with the Cassegrain system on the side of the primary mirror distal of the secondary for use in aligning a target with the laser beam. A first alternate embodiment includes a Cassegrain system using a series of shutters and an internally mounted dichroic mirror. A second alternate embodiment uses two laser focus compensating sensing and imaging devices for aligning a moving tool with a work piece.

  19. Laser focus compensating sensing and imaging device

    DOEpatents

    Vann, Charles S.

    1993-01-01

    A laser focus compensating sensing and imaging device permits the focus of a single focal point of different frequency laser beams emanating from the same source point. In particular it allows the focusing of laser beam originating from the same laser device but having differing intensities so that a low intensity beam will not convert to a higher frequency when passing through a conversion crystal associated with the laser generating device. The laser focus compensating sensing and imaging device uses a cassegrain system to fold the lower frequency, low intensity beam back upon itself so that it will focus at the same focal point as a high intensity beam. An angular tilt compensating lens is mounted about the secondary mirror of the cassegrain system to assist in alignment. In addition cameras or CCD's are mounted with the primary mirror to sense the focused image. A convex lens is positioned co-axial with the cassegrain system on the side of the primary mirror distal of the secondary for use in aligning a target with the laser beam. A first alternate embodiment includes a cassegrain system using a series of shutters and an internally mounted dichroic mirror. A second alternate embodiment uses two laser focus compensating sensing and imaging devices for aligning a moving tool with a work piece.

  20. Medical Device Integration Model Based on the Internet of Things.

    PubMed

    Hao, Aiyu; Wang, Ling

    2015-01-01

    At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medical devices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medical devices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medical devices has long been a difficult problem for the medical information system, because the data from medical devices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medical device integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching

  1. Medical Device Integration Model Based on the Internet of Things

    PubMed Central

    Hao, Aiyu; Wang, Ling

    2015-01-01

    At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medical devices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medical devices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medical devices has long been a difficult problem for the medical information system, because the data from medical devices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medical device integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching

  2. Cybersecurity and medical devices: A practical guide for cardiac electrophysiologists

    PubMed Central

    Kramer, Daniel B.; Foo Kune, Denis; Auto de Medeiros, Julio; Yan, Chen; Xu, Wenyuan; Crawford, Thomas; Fu, Kevin

    2017-01-01

    Abstract Medical devices increasingly depend on software. While this expands the ability of devices to perform key therapeutic and diagnostic functions, reliance on software inevitably causes exposure to hazards of security vulnerabilities. This article uses a recent high‐profile case example to outline a proactive approach to security awareness that incorporates a scientific, risk‐based analysis of security concerns that supports ongoing discussions with patients about their medical devices. PMID:28512774

  3. Cybersecurity and medical devices: A practical guide for cardiac electrophysiologists.

    PubMed

    Ransford, Benjamin; Kramer, Daniel B; Foo Kune, Denis; Auto de Medeiros, Julio; Yan, Chen; Xu, Wenyuan; Crawford, Thomas; Fu, Kevin

    2017-08-01

    Medical devices increasingly depend on software. While this expands the ability of devices to perform key therapeutic and diagnostic functions, reliance on software inevitably causes exposure to hazards of security vulnerabilities. This article uses a recent high-profile case example to outline a proactive approach to security awareness that incorporates a scientific, risk-based analysis of security concerns that supports ongoing discussions with patients about their medical devices. © 2017 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals, Inc.

  4. Strengthening the Role of Nurses in Medical Device Development.

    PubMed

    Castner, Jessica; Sullivan, Suzanne S; Titus, Albert H; Klingman, Karen J

    2016-01-01

    Medical devices and innovative technology promise to revolutionize health care. Despite the importance of involving nurses in the collaborative medical device development processes, there are few learning opportunities in nursing programs. The purpose of this article is to provide a conceptual guide for nurse educators and researchers to engage nursing expertise in medical device development processes. A review of the literature guided the creation of the "Strengthening the Role of Nurses in Medical Device Development Roadmap" model. The model was used to describe how nurses can be engaged in multidisciplinary design of medical devices. An academic transdisciplinary team piloted the application of the model. The model includes the stages of needs assessment, planned brainstorm, feasibility determination, concept design, and prototype building. A transdisciplinary team case study of improving an asthma home-monitoring devices illustrates effective application of the model. Nurse leaders in the academic setting can effectively use the "Strengthening the Role of Nurses in Medical Device Development Roadmap" to inform their engagement of nurses in early medical device development and innovation processes. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. The economic evaluation of medical devices: challenges ahead.

    PubMed

    Kirisits, Andreas; Redekop, W Ken

    2013-02-01

    The economic evaluation of medical technology has evolved as a key element in supporting health budget allocation decisions. Among suppliers of innovation, the medical device industry is one of the most dynamic fields of medical progress with thousands of new products marketed every year. Accordingly, the broad variety of technologies covered by the umbrella term 'medical devices' have come under increasing scrutiny regarding their cost effectiveness. In the process, a number of device-specific factors have become apparent, each of which can complicate a thorough economic evaluation and limit its informative value. Some of these factors relate to specific characteristics of device functioning. Examples of such factors include the fact that most technologies require, or form part of, a procedure and that many devices have multiple indications or purposes. Others in turn reflect external conditions and are more general in character, such as the regulatory framework that a medical device manufacturer faces prior to market approval and the structure of the medical device industry. Drawing on the available literature, these complicating factors and their practical implications are discussed and used as a basis to elaborate on the emerging challenges for the economic evaluation of medical devices.

  6. Application of Diffraction Enhanced Imaging to Medical Imaging

    DTIC Science & Technology

    2001-06-01

    to mammography and other areas of medical imaging . Prof. Chapman is a co-developer of the technique and intends to determine the applicability of... medical imaging . This award has allowed Prof. Chapman to: 1) explore the potential application of Diffraction Enhanced Imaging to mammography, 2...cancer research, and medical imaging , 4) explore the possibility of developing a dedicated imaging program at the Advanced Photon Source, with the

  7. Client-side Medical Image Colorization in a Collaborative Environment.

    PubMed

    Virag, Ioan; Stoicu-Tivadar, Lăcrămioara; Crişan-Vida, Mihaela

    2015-01-01

    The paper presents an application related to collaborative medicine using a browser based medical visualization system with focus on the medical image colorization process and the underlying open source web development technologies involved. Browser based systems allow physicians to share medical data with their remotely located counterparts or medical students, assisting them during patient diagnosis, treatment monitoring, surgery planning or for educational purposes. This approach brings forth the advantage of ubiquity. The system can be accessed from a any device, in order to process the images, assuring the independence towards having a specific proprietary operating system. The current work starts with processing of DICOM (Digital Imaging and Communications in Medicine) files and ends with the rendering of the resulting bitmap images on a HTML5 (fifth revision of the HyperText Markup Language) canvas element. The application improves the image visualization emphasizing different tissue densities.

  8. Medical Image Retrieval: A Multimodal Approach

    PubMed Central

    Cao, Yu; Steffey, Shawn; He, Jianbiao; Xiao, Degui; Tao, Cui; Chen, Ping; Müller, Henning

    2014-01-01

    Medical imaging is becoming a vital component of war on cancer. Tremendous amounts of medical image data are captured and recorded in a digital format during cancer care and cancer research. Facing such an unprecedented volume of image data with heterogeneous image modalities, it is necessary to develop effective and efficient content-based medical image retrieval systems for cancer clinical practice and research. While substantial progress has been made in different areas of content-based image retrieval (CBIR) research, direct applications of existing CBIR techniques to the medical images produced unsatisfactory results, because of the unique characteristics of medical images. In this paper, we develop a new multimodal medical image retrieval approach based on the recent advances in the statistical graphic model and deep learning. Specifically, we first investigate a new extended probabilistic Latent Semantic Analysis model to integrate the visual and textual information from medical images to bridge the semantic gap. We then develop a new deep Boltzmann machine-based multimodal learning model to learn the joint density model from multimodal information in order to derive the missing modality. Experimental results with large volume of real-world medical images have shown that our new approach is a promising solution for the next-generation medical imaging indexing and retrieval system. PMID:26309389

  9. Variable Shadow Screens for Imaging Optical Devices

    NASA Technical Reports Server (NTRS)

    Lu, Ed; Chretien, Jean L.

    2004-01-01

    Variable shadow screens have been proposed for reducing the apparent brightnesses of very bright light sources relative to other sources within the fields of view of diverse imaging optical devices, including video and film cameras and optical devices for imaging directly into the human eye. In other words, variable shadow screens would increase the effective dynamic ranges of such devices. Traditionally, imaging sensors are protected against excessive brightness by use of dark filters and/or reduction of iris diameters. These traditional means do not increase dynamic range; they reduce the ability to view or image dimmer features of an image because they reduce the brightness of all parts of an image by the same factor. On the other hand, a variable shadow screen would darken only the excessively bright parts of an image. For example, dim objects in a field of view that included the setting Sun or bright headlights could be seen more readily in a picture taken through a variable shadow screen than in a picture of the same scene taken through a dark filter or a narrowed iris. The figure depicts one of many potential variations of the basic concept of the variable shadow screen. The shadow screen would be a normally transparent liquid-crystal matrix placed in front of a focal-plane array of photodetectors in a charge-coupled-device video camera. The shadow screen would be placed far enough from the focal plane so as not to disrupt the focal-plane image to an unacceptable degree, yet close enough so that the out-of-focus shadows cast by the screen would still be effective in darkening the brightest parts of the image. The image detected by the photodetector array itself would be used as feedback to drive the variable shadow screen: The video output of the camera would be processed by suitable analog and/or digital electronic circuitry to generate a negative partial version of the image to be impressed on the shadow screen. The parts of the shadow screen in front of

  10. Product-based Safety Certification for Medical Devices Embedded Software.

    PubMed

    Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

    2015-01-01

    Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

  11. Practice of Regulatory Science (Development of Medical Devices).

    PubMed

    Niimi, Shingo

    2017-01-01

     Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made. In the approval application process, medical devices are divided into new, improved, and generic types. Reviewers judge the validity of intended use, indications, operation procedures, and precautions, and in addition evaluate the balance between risk and benefit in terms of efficacy and safety. Other characteristics of medical devices are the need for the user to attain proficiency in usage techniques to ensure efficacy and safety, and the existence of a variety of medical devices for which assessment strategies differ, including differences in impact on the body in cases in which a physical burden to the body or failure of a medical device develops. Regulatory science of medical devices involves prediction, judgment, and evaluation of efficacy, safety, and quality, from which data result which can become indices in the development stages from design to application for approval. A reduction in the number of animals used for testing, improvement in efficiency, reduction of the necessity for clinical trials, etc. are expected through rational setting of evaluation items.

  12. Microbial colonization of medical devices and novel preventive strategies.

    PubMed

    Shunmugaperumal, Tamilvanan

    2010-06-01

    Upon implantation or insertion into patient's body for exerting the intended purpose like salvage of normal functions of vital organs, the medical devices are unfortunately becoming the sites of competition between host cell integration and microbial adhesion. Moreover, since there is an increased use of implanted medical devices, the incidence of biofilm-and medical devices-related nosocomial infections is also increasing progressively. To control microbial colonization and subsequent biofilm formation of the medical devices, different approaches either to enhance the efficiency of certain antimicrobial agents or to disrupt the basic physiology of the pathogenic microorganisms including novel small molecules and antipathogenic drugs are being explored. In addition, the various lipid-and polymer-based drug delivery carriers are also investigated for applying antibiofilm coating of the medical devices especially over catheters. The main intention of this review is therefore to summarize the major and/breakthrough inventions disclosed in patent literature as well as in research papers related to microbial colonization of medical devices and novel preventive strategies. This review starts with an overview of the preventive strategies followed by a short description about the potential of different lipidic-and polymeric-drug delivery carriers in eradicating the biofilm-associated infections from the medical devices.

  13. NEED FOR HARMONIZATION OF LABELING OF MEDICAL DEVICES: A REVIEW

    PubMed Central

    Songara, Raiendra K.; Sharma, Ganesh N.; Gupta, Vipul K.; Gupta, Promila

    2010-01-01

    Medical device labeling is any information associated with a device targeted to the patient or lay caregiver. It is intended to help assure that the device is used safely and effectively. Medical device labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes. The European commission has discussed a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies, proof of conformity in connection with medical devices. Device labeling is exceedingly difficult for manufacturers for many reasons like regulations from government bodies to ensure compliance, increased competent authority surveillance, increased audits and language requirements. PMID:22247840

  14. The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems.

    PubMed

    Weininger, Sandy; Jaffe, Michael B; Goldman, Julian M

    2017-01-01

    Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account these systems' perspective. In this article, we describe the current development of medical device standards and the need for these standards to address medical device informatics. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Five clinical examples show how medical device informatics principles, if applied in the development of medical device standards, could help facilitate the development of safe interoperable medical device systems. These examples illustrate the clinical implications of the failure to capture important signals and device attributes. We provide recommendations relating to the coordination between historically separate standards development groups, some of which focus on safety and effectiveness and others focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that device-to-device interactions and related safety information are considered during standards development.

  15. 76 FR 6551 - Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... a comprehensive system for regulation of medical devices intended for human use. Section 513 of the... HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery... 807 of the regulations. Section 513(f)(2) of the FD&C Act provides that any person who submits a...

  16. 76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was... of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee would be...

  17. 75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was... Surgery Devices Panel of the Medical Devices Advisory Committee would be held on November 18, 2010. On...

  18. A review of m-health in medical imaging.

    PubMed

    Perera, Chandrashan Mahendra; Chakrabarti, Rahul

    2015-02-01

    The increasing capabilities of camera-equipped mobile phones have led to a growing body of evidence regarding their use in medical imaging across a broad range of medical specialties. This article reviews the current evidence for the use of mobile health (m-health) in medical imaging. We performed a structured review of the published literature regarding m-health in medical imaging using the Medline, PubMed, and Web of Science databases (January 2002-August 2013). The two authors independently extracted data regarding type of specialty, purpose, and study design of publications. In total, 235 articles were identified. The majority of studies were case reports or noncomparative product validation studies. The greatest volume of publications originated in the fields of radiology (21%), dermatology (15%), laboratory techniques (15%), and plastic surgery (12%). Among these studies, m-health was used as diagnostic aids, for patient monitoring, and to improve communication between health practitioners. With the growing use of mobile phones for medical imaging, considerations need to be given to informed consent, privacy, image storage and transfer, and guidelines for healthcare workers and patients. There are several novel uses of mobile devices for medical imaging that show promise across a variety of areas and subspecialties of healthcare. Currently, studies are mostly exploratory in nature. To validate these devices, studies with higher methodological rigor are required.

  19. Theory of Electron Imaging in Small Devices

    SciTech Connect

    Heller, Eric J.

    2015-05-21

    The research in this program involved theoretical investigations of the transport of charge in graphene and small heterostructure devices. There is an important trend toward imaging electronic systems in real space, with the goal of understanding the specifics of individual samples rather than settling for ensemble and statistical descriptions. For example one of our goals has been the understanding of scanning probe microscopy (SPM) imaging of systems in which the motion of the carriers is restricted to two degrees of freedom, such as in grapheme and the two dimensional electron (and hole) gas (2DEGs and 2DHGs) in GaAs/AlGaAs heterostructures, or when the motion is restricted to one degree of freedom as in nanowires. SPM imaging uses the tip of a movable charged probe to alter the electrons locally, depleting or alternatively increasing the amount of charges in the electron gas just below the tip results in a change to the flow pattern of the charge. The focus of this research was on understanding how the tunable tip affects functional aspects of the device that can be used to understand electronic and transport properties. For instance, scanning over the device while measuring the conductance results in conductance maps, an imaging of the charge transport. This imaging is often semi-direct and requires theory and interpretation to extract all that can be deduced about the underlying physical quantities.

  20. Image-Capture Devices Extend Medicine's Reach

    NASA Technical Reports Server (NTRS)

    2009-01-01

    Johnson Space Center, Henry Ford Hospital in Detroit, and Houston-based Wyle Laboratories collaborated on NASA's Advanced Diagnostic Ultrasound in Microgravity (ADUM) experiment, which developed revolutionary medical ultrasound diagnostic techniques for long-distance use. Mediphan, a Canadian company with U.S. operations in Springfield, New Jersey drew on NASA expertise to create frame-grabber and data archiving technology that enables ultrasound users with minimal training to send diagnostic-quality ultrasound images and video to medical professionals via the Internet in near real time allowing patients as varied as professional athletes, Olympians, and mountain climbers to receive medical attention as soon as it is needed.

  1. Serious adverse event reporting in a medical device information system.

    PubMed

    Pecoraro, Fabrizio; Luzi, Daniela

    2011-01-01

    The paper describes the design of a module that manages Serious Adverse Events (SAEs) reporting within a Clinical investigation on Medical devices. This module is integrated in a Medical Device Information System (MEDIS) that collects data and documents exchanged between applicants and the National Competent Authority during the clinical investigation lifecycle. To improve information sharing among different stakeholders and systems MEDIS design and developed were based on the HL7 v.3 standards. The paper provides a conceptual model on SAEs based on HL7 RIM that underlines Medical Device characteristics.

  2. A concept ideation framework for medical device design.

    PubMed

    Hagedorn, Thomas J; Grosse, Ian R; Krishnamurty, Sundar

    2015-06-01

    Medical device design is a challenging process, often requiring collaboration between medical and engineering domain experts. This collaboration can be best institutionalized through systematic knowledge transfer between the two domains coupled with effective knowledge management throughout the design innovation process. Toward this goal, we present the development of a semantic framework for medical device design that unifies a large medical ontology with detailed engineering functional models along with the repository of design innovation information contained in the US Patent Database. As part of our development, existing medical, engineering, and patent document ontologies were modified and interlinked to create a comprehensive medical device innovation and design tool with appropriate properties and semantic relations to facilitate knowledge capture, enrich existing knowledge, and enable effective knowledge reuse for different scenarios. The result is a Concept Ideation Framework for Medical Device Design (CIFMeDD). Key features of the resulting framework include function-based searching and automated inter-domain reasoning to uniquely enable identification of functionally similar procedures, tools, and inventions from multiple domains based on simple semantic searches. The significance and usefulness of the resulting framework for aiding in conceptual design and innovation in the medical realm are explored via two case studies examining medical device design problems. Copyright © 2015 Elsevier Inc. All rights reserved.

  3. Adapting smartphones for low-cost optical medical imaging

    NASA Astrophysics Data System (ADS)

    Pratavieira, Sebastião.; Vollet-Filho, José D.; Carbinatto, Fernanda M.; Blanco, Kate; Inada, Natalia M.; Bagnato, Vanderlei S.; Kurachi, Cristina

    2015-06-01

    Optical images have been used in several medical situations to improve diagnosis of lesions or to monitor treatments. However, most systems employ expensive scientific (CCD or CMOS) cameras and need computers to display and save the images, usually resulting in a high final cost for the system. Additionally, this sort of apparatus operation usually becomes more complex, requiring more and more specialized technical knowledge from the operator. Currently, the number of people using smartphone-like devices with built-in high quality cameras is increasing, which might allow using such devices as an efficient, lower cost, portable imaging system for medical applications. Thus, we aim to develop methods of adaptation of those devices to optical medical imaging techniques, such as fluorescence. Particularly, smartphones covers were adapted to connect a smartphone-like device to widefield fluorescence imaging systems. These systems were used to detect lesions in different tissues, such as cervix and mouth/throat mucosa, and to monitor ALA-induced protoporphyrin-IX formation for photodynamic treatment of Cervical Intraepithelial Neoplasia. This approach may contribute significantly to low-cost, portable and simple clinical optical imaging collection.

  4. First-in-Human Clinical Trials of Imaging Devices: An Example from Optical Imaging

    PubMed Central

    Gibbs-Strauss, Summer L.; Rosenberg, Mireille; Clough, Barbara L.; Troyan, Susan L.; Frangioni, John V.

    2009-01-01

    Clinical translation of scientific discoveries is often the long-term goal of academic medical research. However, this goal is not always realized due to the complicated path between bench research and clinical use. In this review, we outline the fundamental steps required for first-in-human testing of a new imaging device, and use the FLARE™ (Fluorescence-Assisted Resection and Exploration) near-infrared fluorescence optical imaging platform as an example. PMID:19964033

  5. First-in-human clinical trials of imaging devices: an example from optical imaging.

    PubMed

    Gibbs-Strauss, Summer L; Rosenberg, Mireille; Clough, Barbara L; Troyan, Susan L; Frangioni, John V

    2009-01-01

    Clinical translation of scientific discoveries is often the long-term goal of academic medical research. However, this goal is not always realized due to the complicated path between bench research and clinical use. In this review, we outline the fundamental steps required for first-in-human testing of a new imaging device, and use the FLARE() (Fluorescence-Assisted Resection and Exploration) near-infrared fluorescence optical imaging platform as an example.

  6. Perinatal staff nurse medical device use and education.

    PubMed

    McConnell, E A

    1998-01-01

    How and what RNs working in the perinatal area initially learned about the medical devices they use and the sequelae of device use both for patients and staff were explored. Eighty-five perinatal staff nurses working at a 500-bed tertiary care hospital in a medium-size midwestern American city were surveyed using a mailed questionnaire comprised of 26 open-ended and closed-ended questions pertaining to device education, consequences of device use, demographic characteristics, and employment situation. Most participants (n = 48, 62.3%) initially learned about the most frequently used device by reading the user/instruction manual. At least 90% (n = 77) of participants indicated they initially had learned how to operate the device, its purpose, function, and patient factors indicating use. Inadequate device knowledge was related to nurse stress, and being unsure how to use the device and fear of harming the patient were the two reasons most frequently identified as causing the stress. Six percent (n = 5) of staff nurses had used a device that caused patient harm. What RNs initially learn about medical devices may be related to how they learn, and the continuing increase in nurse use of medical devices has implications for all aspects of professional nursing: curriculum, teaching clinical nursing, continuing education and staff development, and research.

  7. FDA's pediatric device consortia: national program fosters pediatric medical device development.

    PubMed

    Ulrich, Linda C; Joseph, Francesca D; Lewis, Debra Y; Koenig, Robert L

    2013-05-01

    This article reports on the progress made in addressing pediatric medical device needs through the establishment of the Pediatric Device Consortia Grant Program. Pediatric practitioners should be aware of both the imperative for well-studied devices for children and the existence of recently created resources to help foster the development of such products. This article discusses some of the challenges associated with pediatric device development and describes the implementation of section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007. This statute called for the creation of nonprofit consortia to facilitate the development, production, and distribution of pediatric medical devices. A summary of the accomplishments of the pediatric device consortia is presented. Eleven million dollars have been awarded to 5 consortia since 2009. As of July 2012, they have collectively assisted in the development of 219 pediatric device ideas. The consortia provide innovators with both mentorship and services to help advance proposed pediatric device projects, including assistance with prototyping, identification of potential funding sources, preclinical and clinical trial design, and introductions to potential manufacturers. Currently, 5 federally funded pediatric device consortia exist to help advance the development of potential pediatric devices. These consortia serve as a national resource for those with ideas for medical devices that may advance the health and well-being of children.

  8. 77 FR 25183 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-27

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... system consists of the following: A heterologous (bovine) pericardium leaflet valve sutured within a...

  9. 76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... mm and accessories implant system consists of the following: The Edwards SAPIEN Transcatheter Heart...

  10. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Immunology Devices Panel of the Medical Devices Advisory.... SUMMARY: The Food and Drug Administration (FDA) is postponing the meeting of the Immunology Devices Panel...

  11. 78 FR 55081 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... Monitoring System. The CardioMEMS HF System is a permanently implantable pressure measurement system...

  12. 75 FR 7282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-18

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... recommendations and vote on a PMA for the REVO MRI Pacemaker System sponsored by Medtronic. The REVO MRI...

  13. 76 FR 63928 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of...: ``Medtronic cardiac resynchronization therapy defibrillator (CRT-D) systems are indicated for heart...

  14. 75 FR 81282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... PMA supplement for the RX Acculink Carotid Stent System, sponsored by Abbott Vascular. The RX...

  15. 78 FR 11208 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-15

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... approval application for the MitraClip Delivery System sponsored by Abbott Vascular. The system consists...

  16. 78 FR 49272 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until...

  17. 76 FR 56200 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-12

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... and are pre-loaded onto 6 or 7 Fr \\1\\ (diameter of 2 or 2.3 mm) delivery systems. Upon deployment,...

  18. 76 FR 58019 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... sponsored by AtriCure, Inc., for the AtriCure Synergy Ablation System to be used for the treatment of...

  19. 77 FR 16038 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... the premarket approval application (PMA) for the HeartWare Ventricular Assist System (HVAS)...

  20. 77 FR 18829 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel...

  1. 78 FR 67365 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel...

  2. Medical device regulation in Australia: safe and effective?

    PubMed

    McGee, Richard G; Webster, Angela C; Rogerson, Thomas E; Craig, Jonathan C

    2012-03-05

    To describe the frequency, characteristics and outcomes of reports of possible harms related to medical devices submitted to the Australian Therapeutic Goods Administration (TGA) using data made publicly available on the TGA website. A retrospective analysis, conducted in January 2012, of data made publicly available on the TGA website from January 2000 to December 2011. The number and nature of reports of medical device incidents, recalls and alerts. Up to December 2011, 6812 incidents involving medical devices were reported to the TGA, although there were several periods where data were unavailable. Incidents were reported more frequently in later years, most often by device sponsors, and were often attributed to mechanical problems. 295 deaths and 2357 serious injuries have been related to incidents, with serious injury (597) highest in 2009. Most incidents involving medical devices were not investigated (47.5%), or, after investigation, no further action was taken (25.0%). During the same time period, there were 35 medical device recalls and 34 medical device alerts issued by the TGA, with no consistent increase over time. Despite TGA reform proposals, greater transparency is still needed. Issues that have not been addressed include patchy and conflicting data in the public domain and lack of explanations for the large proportion of uninvestigated reports. To maintain public confidence in the national regulatory system these problems need to be resolved.

  3. [The current situation and consideration on the quality of medical device standards in China].

    PubMed

    Yang, Xiaofang; Mu, Rui hong; Li, Jingli

    2014-09-01

    Through the analysis of the present problems of the quality of medical device standards in China, combined with the development trend of the last ten years of medical devices, the paper made proposals on the medical device standards quality evaluation system, so as to improve the medical device standards management level and the quality of medical device standard in our country.

  4. Legal framework conditions for the reprocessing of medical devices.

    PubMed

    Großkopf, Volker; Jäkel, Christian

    2008-09-03

    The processing of single-use products is permissible pursuant to medical device law. This is apparent both from the wording of the German Law on Medical Devices and from the purpose and the objectives underpinning the legislative materials. The prerequisite for processing is, however, compliance with the the Joint Recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Products (BfArM).For medical devices in the category "critical C", the RKI/BfArM-recommendation provides that the processor's quality management system must be certified by a body accredited by the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG). The certification must be carried out in accordance with EN ISO 13485:2003+AC:2007.On April 4, 2008 the Federal Health Ministry (Bundesministerium für Gesundheit, BMG) presented a progress report on the processing of medical devices. The BMG concludes that the legal framework for the processing of medical devices is sufficient, and that a prohibition on the processing of single-use products is inappropriate.

  5. Standalone medical device software: The evolving regulatory framework.

    PubMed

    McCarthy, Avril D; Lawford, Patricia V

    2014-01-01

    The paper provides an introduction to the regulatory landscape affecting a particular category of medical technology, namely standalone software-sometimes referred to as 'software as a medical device'. To aid the reader's comprehension of an often complex area, six case studies are outlined and discussed before the paper continues to provide detail of how software with a medical purpose in its own right can potentially be classified as a medical device. The reader is provided an appreciation of how to go about classifying such software and references to support the developer new to the field in locating detailed regulatory support documents and contact points for advice.

  6. Medical Image Tamper Detection Based on Passive Image Authentication.

    PubMed

    Ulutas, Guzin; Ustubioglu, Arda; Ustubioglu, Beste; V Nabiyev, Vasif; Ulutas, Mustafa

    2017-05-08

    Telemedicine has gained popularity in recent years. Medical images can be transferred over the Internet to enable the telediagnosis between medical staffs and to make the patient's history accessible to medical staff from anywhere. Therefore, integrity protection of the medical image is a serious concern due to the broadcast nature of the Internet. Some watermarking techniques are proposed to control the integrity of medical images. However, they require embedding of extra information (watermark) into image before transmission. It decreases visual quality of the medical image and can cause false diagnosis. The proposed method uses passive image authentication mechanism to detect the tampered regions on medical images. Structural texture information is obtained from the medical image by using local binary pattern rotation invariant (LBPROT) to make the keypoint extraction techniques more successful. Keypoints on the texture image are obtained with scale invariant feature transform (SIFT). Tampered regions are detected by the method by matching the keypoints. The method improves the keypoint-based passive image authentication mechanism (they do not detect tampering when the smooth region is used for covering an object) by using LBPROT before keypoint extraction because smooth regions also have texture information. Experimental results show that the method detects tampered regions on the medical images even if the forged image has undergone some attacks (Gaussian blurring/additive white Gaussian noise) or the forged regions are scaled/rotated before pasting.

  7. Qualitative approach to medical image databases

    NASA Astrophysics Data System (ADS)

    Bizais, Yves J.; Gibaud, Bernard; Forte, Anne-Marie; Aubry, Florent; Di Paola, Robert; Scarabin, Jean-Marie

    1991-07-01

    The development of PACS image databases has long been thought of as a major technological challenge, due to the amount of data to be managed. On the contrary, the authors think that despite major improvements in storage technology, new data management techniques must be proposed to make image databases medically useful in PACS environments. More precisely, image databases must contain not only images per se, but also the description of all objects used in medical imaging, in order to permit the remote processing, analysis, and interpretation of images. In several other papers, the authors explain why they adopted an object-oriented approach to model information in medical imaging. In this paper, the focus is on the inventory of objects manipulated in medical imaging from a qualitative viewpoint. For this purpose, a large number of representative imaging procedures were selected. The authors characterized how they are asked for by clinicians, realized in imaging departments, and consumed by requiring physicians and surgeons, in three French university hospitals. On the basis of this inventory, a set of image data -- i.e. of objects used in medical imaging -- was defined to show that this set must evolve with advances in medical imaging, and to point out that relational DBMS concepts cannot represent all image data.

  8. Medical devices; medical device distributor reporting--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date.

    PubMed

    1993-09-01

    The Food and Drug Administration (FDA) is announcing that the tentative final rule on medical device distributor reporting that appeared in the Federal Register of November 26, 1991 (56 FR 60024), is now a final rule by operation of law. This final rule requires distributors to submit reports to FDA and to manufacturers, of deaths, serious illnesses, and serious injuries related to medical devices and to submit reports to manufacturers of certain malfunctions that may cause a death, serious illness, or serious injury, if the malfunction were to recur. The final rule also changes the reporting standard for certain distributors that are importers, and changes the definition of the term "serious injury" to conform to a recent statutory amendment. In issuing this final rule, FDA is announcing that the tentative final rule relating to adverse event reporting requirements for distributors, including importers, has the status of a final rule, as of May 28, 1992, by operation of law under the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments), and is setting forth the regulations reflecting those requirements. FDA is also amending the regulations, based on consideration of comments on the November 26, 1991, tentative final rule, to require distributors to register their facilities and to list their devices with FDA.

  9. Robotic 3D scanner as an alternative to standard modalities of medical imaging.

    PubMed

    Chromy, Adam; Zalud, Ludek

    2014-01-01

    There are special medical cases, where standard medical imaging modalities are able to offer sufficient results, but not in the optimal way. It means, that desired results are produced with unnecessarily high expenses, with redundant informations or with needless demands on patient. This paper deals with one special case, where information useful for examination is the body surface only, inner sight into the body is needless. New specialized medical imaging device is developed for this situation. In the Introduction section, analysis of presently used medical imaging modalities is presented, which declares, that no available imaging device is best fitting for mentioned purposes. In the next section, development of the new specialized medical imaging device is presented, and its principles and functions are described. Then, the parameters of new device are compared with present ones. It brings significant advantages comparing to present imaging systems.

  10. Quality management for the processing of medical devices.

    PubMed

    Klosz, Kerstin

    2008-09-03

    Rules on the reprocessing of medical devices were put into place in Germany in 2001. The present article explains the background situation and the provisions that are currently in force.The implementation of these statutory requirements is described using the example of the quality management system of Germany's market leader, Vanguard AG. This quality management system was successfully certified pursuant to DIN EN ISO 13485:2003 for the scope "reprocessing of medical devices", including class "critical C", in accordance with the recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert-Koch-Institute (RKI) and the German Federal Institute for Drugs and Medical Devices (BfArM) on the "Hygiene requirements for reprocessing of medical devices".

  11. [Ethic review on clinical experiments of medical devices in medical institutions].

    PubMed

    Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

    2011-07-01

    Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

  12. Cerenkov luminescence imaging of medical isotopes

    PubMed Central

    Ruggiero, Alessandro; Holland, Jason P.; Lewis, Jason S.; Grimm, Jan

    2011-01-01

    The development of novel multimodality imaging agents and techniques represents the current frontier of research in the field of medical imaging science. However, the combination of nuclear tomography with optical techniques has yet to be established. Here, we report the use of the inherent optical emissions from the decay of radiopharmaceuticals for Cerenkov luminescence imaging (CLI) of tumors in vivo and correlate the results with those obtained from concordant immuno-PET studies. Methods In vitro phantom studies were used to validate the visible light emission observed from a range of radionuclides including the positron emitters 18F, 64Cu, 89Zr, and 124I; β-emitter 131I; and α-particle emitter 225Ac for potential use in CLI. The novel radiolabeled monoclonal antibody 89Zr-desferrioxamine B-[DFO-J591 for immuno-PET of prostate-specific membrane antigen (PSMA) expression was used to coregister and correlate the CLI signal observed with the immuno-PET images and biodistribution studies. Results Phantom studies confirmed that Cerenkov radiation can be observed from a range of positron-,β-, and α-emitting radionuclides using standard optical imaging devices. The change in light emission intensity versus time was concordant with radionuclide decay and was also found to correlate linearly with both the activity concentration and the measured PET signal (percentage injected dose per gram). In vivo studies conducted in male severe combined immune deficient mice bearing PSMA-positive, subcutaneous LNCaP tumors demonstrated that tumor-specific uptake of 89Zr-DFO-J591 could be visualized by both immuno-PET and CLI. Optical and immuno-PET signal intensities were found to increase over time from 24 to 96 h, and biodistribution studies were found to correlate well with both imaging modalities. Conclusion These studies represent the first, to our knowledge, quantitative assessment of CLI for measuring radiotracer uptake in vivo. Many radionuclides common to both nuclear

  13. Cerenkov luminescence imaging of medical isotopes.

    PubMed

    Ruggiero, Alessandro; Holland, Jason P; Lewis, Jason S; Grimm, Jan

    2010-07-01

    The development of novel multimodality imaging agents and techniques represents the current frontier of research in the field of medical imaging science. However, the combination of nuclear tomography with optical techniques has yet to be established. Here, we report the use of the inherent optical emissions from the decay of radiopharmaceuticals for Cerenkov luminescence imaging (CLI) of tumors in vivo and correlate the results with those obtained from concordant immuno-PET studies. In vitro phantom studies were used to validate the visible light emission observed from a range of radionuclides including the positron emitters (18)F, (64)Cu, (89)Zr, and (124)I; beta-emitter (131)I; and alpha-particle emitter (225)Ac for potential use in CLI. The novel radiolabeled monoclonal antibody (89)Zr-desferrioxamine B [DFO]-J591 for immuno-PET of prostate-specific membrane antigen (PSMA) expression was used to coregister and correlate the CLI signal observed with the immuno-PET images and biodistribution studies. Phantom studies confirmed that Cerenkov radiation can be observed from a range of positron-, beta-, and alpha-emitting radionuclides using standard optical imaging devices. The change in light emission intensity versus time was concordant with radionuclide decay and was also found to correlate linearly with both the activity concentration and the measured PET signal (percentage injected dose per gram). In vivo studies conducted in male severe combined immune deficient mice bearing PSMA-positive, subcutaneous LNCaP tumors demonstrated that tumor-specific uptake of (89)Zr-DFO-J591 could be visualized by both immuno-PET and CLI. Optical and immuno-PET signal intensities were found to increase over time from 24 to 96 h, and biodistribution studies were found to correlate well with both imaging modalities. These studies represent the first, to our knowledge, quantitative assessment of CLI for measuring radiotracer uptake in vivo. Many radionuclides common to both nuclear

  14. Tooling Techniques Enhance Medical Imaging

    NASA Technical Reports Server (NTRS)

    2012-01-01

    mission. The manufacturing techniques developed to create the components have yielded innovations advancing medical imaging, transportation security, and even energy efficiency.

  15. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine, medical...

  16. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine, medical...

  17. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine, medical...

  18. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine, medical...

  19. Post-approval studies in France, challenges facing medical devices.

    PubMed

    Levesque, Karine; Coqueblin, Claire; Guillot, Bernard; Aubourg, Lucie; Avouac, Bernard; Carbonneil, Cédric; Cucherat, Michel; Descamps-Mandine, Patricia; Hanoka, Serge; Goldberg, Marcel; Josseran, Anne; Parquin, François; Pitel, Séverine; Ratignier, Christelle; Sechoy, Odile; Szwarcenstein, Karine; Tanti, André; Teiger, Emmanuel; Thevenet, Nicolas

    2014-01-01

    Medical devices are characterized notably by a wide heterogeneity (from tongue depressors to hip prostheses, and from non-implantable to invasive devices), a short life cycle with recurrent incremental innovations (from 18 months to 5 years), and an operator-dependent nature. The objective of the current round table was to develop proposals and recommendations concerning the prerequisites needed in order to meet the French health authorities expectations concerning requests for post-approval studies for medical devices, required in cases where short and long-term consequences are unknown. These studies, which are the responsibility of the manufacturer or the distributor of the medical device, are designed to confirm the role of the medical device in the therapeutic management strategy in a real-life setting. There are currently approximately 150 post-approval studies underway, mainly concerning class III devices, and the majority face difficulties implementing the study or meeting the study objectives. In light of this, the round table endeavored to clearly identify the conditions for implementation of post-approval studies specific to the characteristics of medical devices. Various areas of progress have been envisaged to improve the performance of these studies, and by consequence, the efficiency of reimbursement of medical devices by the national health insurance. These include providing manufacturers with the opportunity to better anticipate post-approval requirements, defining a study-specific primary objective, integrating a phase allowing dialogue between the manufacturer, the health authorities and the scientific committee, and increasing awareness and training of health professionals on the impact of post-approval clinical studies in terms of the reimbursement of medical devices by the national insurance.

  20. U.S. medical device reporting: who is responsible?

    PubMed

    Donawa, Maria

    2005-04-01

    When various companies are involved in the manufacture and export of medical devices to the United States (U.S.), it is not always easy to understand the reporting responsibilities under the U.S. Medical Device Reporting regulation. A new rule has been published to help companies better understand the requirements. This article discusses the new rule, ways to determine responsibilities and suggestions for compliance.

  1. Medical imaging V: Image capture, formatting, and display

    SciTech Connect

    Kim, Y.

    1991-01-01

    This book is covered under the following topics: Digital image display I-V; Quality assurance I-V; Clinical image presentation I-V; Imaging systems; Image compression; Workstations; and Medical diagnostic imaging support system for military medicine and other federal agencies.

  2. Development of Implantable Medical Devices: From an Engineering Perspective

    PubMed Central

    2013-01-01

    From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medical device development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medical devices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medical devices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medical devices will be presented from the viewpoint of an engineering mind. PMID:24143287

  3. The digital radiographic and computed tomography imaging of two types of explosive devices.

    PubMed

    Galiano Riveros, Eduardo

    2002-12-01

    Two well-established medical imaging methods, digital radiography (DR) and computed tomography (CT), were employed to obtain images of two types of explosive devices, model rocket engines and shotgun shells. The images were evaluated from an airport security perspective. In terms of geometrical shape, the detection probability of the explosive devices appears to be higher with DR imaging, but in terms of the actual explosive compounds in the devices, CT appears to offer a higher detection probability. DR imaging offers a low detection probability for the explosive powder in the shotgun shells, but a rather significant detection probability for the explosive propellant in the model rocket engines.

  4. Radiofrequency interference with medical devices. A technical information statement.

    PubMed

    1998-01-01

    The past few years have seen increased reports that medical devices, such as pacemakers, apnea monitors, electrically powered wheelchairs, etc., have failed to operate correctly because of interference from various emitters of radiofrequency energy. This condition is called radiofrequency interference (RFI). The consequences of these failures range from inconvenience to serious injuries and death. Reasons for this problem are twofold: 1) increasing numbers of electronically controlled medical devices with inadequate electronic protection against RFI, and 2) a significant increase in the number of RF sources in the environment. Medical devices are widely used outside the hospital and may be attached to, or implanted in, patients. Portable wireless communications equipment, including cellular phones, handheld transceivers, and vehicle-mounted transceivers, comprise one of the largest sources of RFI. Some medical devices are especially sensitive to the type of digital modulation that some of the wireless communications devices utilize. The prevailing international standard for the RF immunity of medical devices is the 1993 revision of the International Electro-technical Commission (IEC) Standard IEC 60601-1-2. This standard sets a minimum immunity level of 3 volts per meter (V/m) in the 26-1000 MHz frequency range. For non-life supporting devices, testing is required only at the specific frequencies of 27.12, 40.68, and 915 MHz. Technology exists to protect, or "harden," most medical devices from RF fields that are much more intense than the 3 V/m level specified in present RFI standards. Most of these techniques, including shielding, grounding, and filtering, are not costly if they are incorporated into the initial design of the electronics system. COMAR recommends that the various parties involved in the manufacture and use of RFI-prone medical devices take steps to avoid serious RFI problems that may lead to safety hazards. Medical device manufacturers should

  5. Optical imaging device of retinal function

    NASA Astrophysics Data System (ADS)

    Kardon, Randy H.; Kwon, Young; Truitt, Paul; Nemeth, Sheila C.; T'so, Dan; Soliz, Peter

    2002-06-01

    An optical imaging device of retina function (OID-RF) has been constructed to record changes in reflected 700-nm light from the fundus caused by retinal activation in response to a visual 535-nm stimulus. The resulting images reveal areas of the retina activated by visual stimulation. This device is a modified fundus camera designed to provide a patterned, moving visual stimulus over a 45-degree field of view to the subject in the green wavelength portion of the visual spectrum while simultaneously imaging the fundus in another, longer wavelength range. Data was collected from 3 normal subjects and recorded for 13 seconds at 4 Hz; 3 seconds were recorded during pre-stimulus baseline, 5 seconds during the stimulus, and 5 seconds post-stimulus. This procedure was repeated several times and, after image registration, the images were averaged to improve signal to noise. The change in reflected intensity from the retina due to the stimulus was then calculated by comparison to the pre-stimulus state. Reflected intensity from areas of stimulated retina began to increase steadily within 1 second after stimulus onset and decayed after stimulus offset. These results indicated that a functional optical signal can be recorded from the human eye.

  6. Legal implications of single-use medical device reprocessing.

    PubMed

    Larose, Emily

    2013-01-01

    Over 10 years ago, the Public Health Agency of Canada released the results of a nation-wide survey of hospitals that demonstrated that the reuse of single-use medical devices was widespread in Canadian healthcare institutions. In this article, the author discusses the reuse and reprocessing of these devices, as well as the risks this practice presents. She then goes on to outline the legal implications of reusing single-use devices.

  7. 75 FR 68200 - Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-05

    ... controls). The device type is intended to produce planar digital x-ray images of the entire breast; this... digital x-ray images of the entire breast. This generic type of device may include digital mammography... 892.1715. The final rule uses the term ``planar'' instead of ``full- field'' to describe digital x-ray...

  8. 76 FR 71982 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... Microbiology/ Medical Countermeasure Devices; Public Meeting; Reopening of Comment Period AGENCY: Food and Drug... Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices'' that published in... highly multiplexed microbiology/medical countermeasure (MCM) devices, their clinical application...

  9. Single-sided magnetic particle imaging device for the sentinel lymph node biopsy scenario

    NASA Astrophysics Data System (ADS)

    Sattel, Timo F.; Erbe, M.; Biederer, S.; Knopp, T.; Finas, D.; Diedrich, K.; Lüdtke-Buzug, K.; Borgert, J.; Buzug, T. M.

    2012-03-01

    Beside the original scanner geometry for Magnetic Particle Imaging (MPI) introduced by Gleich et. al. in 2005,1 alternative scanner geometries have been introduced.2-4 In excess of the opportunities in medical application offered by MPI itself, these new scanner geometries permit additional medical application scenarios. Here, the single-sided scanner geometry is implemented as imaging device for supporting the sentinel lymph node biopsy concept. In this contribution, the medical application is outlined, and the geometry of the scanner device is presented together with first simulation results providing information about the achievable image quality.

  10. Formal verification of software-based medical devices considering medical guidelines.

    PubMed

    Daw, Zamira; Cleaveland, Rance; Vetter, Marcus

    2014-01-01

    Software-based devices have increasingly become an important part of several clinical scenarios. Due to their critical impact on human life, medical devices have very strict safety requirements. It is therefore necessary to apply verification methods to ensure that the safety requirements are met. Verification of software-based devices is commonly limited to the verification of their internal elements without considering the interaction that these elements have with other devices as well as the application environment in which they are used. Medical guidelines define clinical procedures, which contain the necessary information to completely verify medical devices. The objective of this work was to incorporate medical guidelines into the verification process in order to increase the reliability of the software-based medical devices. Medical devices are developed using the model-driven method deterministic models for signal processing of embedded systems (DMOSES). This method uses unified modeling language (UML) models as a basis for the development of medical devices. The UML activity diagram is used to describe medical guidelines as workflows. The functionality of the medical devices is abstracted as a set of actions that is modeled within these workflows. In this paper, the UML models are verified using the UPPAAL model-checker. For this purpose, a formalization approach for the UML models using timed automaton (TA) is presented. A set of requirements is verified by the proposed approach for the navigation-guided biopsy. This shows the capability for identifying errors or optimization points both in the workflow and in the system design of the navigation device. In addition to the above, an open source eclipse plug-in was developed for the automated transformation of UML models into TA models that are automatically verified using UPPAAL. The proposed method enables developers to model medical devices and their clinical environment using clinical workflows as one

  11. Medical device integration using mobile telecommunications infrastructure.

    PubMed

    Moorman, Bridget A; Cockle, Richard A

    2013-01-01

    Financial pressures, an aging population, and a rising number of patients with chronic diseases, have encouraged the use of remote monitoring technologies. This usually entails at least one physiological parameter measurement for a clinician. Mobile telecommunication technologies lend themselves to this functionality, and in some cases, avoid some of the issues encountered with device integration. Moreover, the inherent characteristics of the mobile telecommunications infrastructure allow a coupling of business and clinical functions that were not possible before. Table I compares and contrasts some key aspect of device integration in and out of a healthcare facility. An HTM professional may be part of the team that acquires and/or manages a system using a mobile telecommunications technology. It is important for HTM professionals to ensure the data is in a standard format so that the interfaces across this system don't become brittle and break easily if one part changes. Moreover, the security and safety considerations of the system and the data should be a primary consideration in and y purchase, with attention given to the proper environmental and encryption mechanisms. Clinical engineers and other HTM professionals are unique in that they understand the patient/clinician/device interface and the need to ensure its safety and effectiveness regardless of geographical environment.

  12. A novel medical device for removal of intrauterine devices under direct vision.

    PubMed

    Su, Shili; Zhao, Zhen; Feng, Shiyan; Dong, Baihua

    2012-11-01

    Evaluation of the efficacy of a novel medical device for removal of retained intrauterine devices (IUDs) under direct vision without uterine distention is reported. The five cases presented used the novel medical device to remove the IUDs. One woman had an incarcerated IUD, two women had fractured IUDs and two women had IUDs with lost threads. All IUDs were removed completely with use of direct vision without uterine distention. The device is effective for the removal of incarceration IUDs under direct vision without uterine distention. Copyright © 2012 Elsevier Inc. All rights reserved.

  13. Enhancing medical device training with hybrid physical-virtual simulators: smart peripherals for virtual devices.

    PubMed

    Samosky, Joseph T; Thornburg, Andrew; Karkhanis, Tushar; Petraglia, Frank; Strickler, Elise; Nelson, Douglas A; Weaver, Robert A; Robinson, Evan

    2013-01-01

    We introduce a novel platform for medical device training: hybrid physical-virtual simulators of medical devices, combining touchscreen-enabled virtual emulations of real devices with sensorized physical peripherals to enable tactile, hands-on interaction between the trainee, simulated device and standardized patients or mannequins. The system enables objective measurement and recording of trainee performance, including interactions with both the virtual device elements and the physical components, and can include metrics and feedback not available in the real device. The system also includes an integrated wireless signaling device for use with standardized patients. We present the implementation of an example system, a virtual defibrillator with sensorized paddles and wireless signaling of successful defibrillator operation.

  14. Effectively utilizing device maintenance data to optimize a medical device maintenance program.

    PubMed

    Brewin, D; Leung, J; Easty, T

    2001-01-01

    Methods developed by the clinical engineering community and the principles outlined by ISO regulations for the application of risk management to medical devices were integrated to provide a basis for the unique optimization system implemented into the University Health Network medical device maintenance program. Device maintenance history data stored in the database is used to conduct a risk analysis and to compute predefined benchmarks to highlight groups of equipment for which the current maintenance regime is not optimal. Using a software data research tool we are able to investigate device history data and support alterations in maintenance intervals, user training, maintenance procedures, and/or device purchasing. These alterations are justified, documented, and monitored for risk in a continuous management cycle. The predicted benefits are an overall improvement in the reliability of the devices maintained, coupled with a drop in repetitive device checks that result in no measurable benefits.

  15. Medical devices in dermatology using DLP technology from Texas Instruments

    NASA Astrophysics Data System (ADS)

    Kock, M.; Lüllau, F.

    2012-03-01

    The market of medical devices is growing continuously worldwide. With the DLP™ technology from Texas Instruments Lüllau Engineering GmbH in Germany has realized different applications in the medical discipline of dermatology. Especially a new digital phototherapy device named skintrek™ PT5 is revolutionizing the treatment of skin diseases like psoriasis , Vitiligo and other Eczema. The functions of the new phototherapy device can only be realized through DLP™ technology which is not only be used for the selective irradiation process. In combination with other optical systems DLP™ technology undertakes also other functionalities like 3D-topology calculation und patient movement compensation.

  16. [Key Technology and Quantity Control of Wearable Medical Devices].

    PubMed

    Cui, Hongen; Yao, Shaowei

    2015-03-01

    In recent years, because the wearable medical devices can indicate the health monitoring index of blood sugar, blood pressure, heart rate, oxygen content, temperature, respiration of the human body anytime and anywhere, can also be used for the treatment of various diseases, accompanied by the development of large data, which will bring a subversive revolution for the medical device industry. This paper introduces the development of wearable devices, key technical index of main products, and to make a preliminary study on its quantity control.

  17. 76 FR 34845 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

    ... Drug Administration 21 CFR Part 874 Medical Devices; Ear, Nose, and Throat Devices; Classification of... established by this final rule create ``requirements'' for specific medical devices under 21 U.S.C. 360k, even..., 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to...

  18. Devices for medical diagnosis with GaN lasers

    NASA Astrophysics Data System (ADS)

    Kwasny, Miroslaw; Mierczyk, Zygmunt

    2003-10-01

    This paper presents laser-induced fluroescence method (LIF) employing endogenous ("autofluroescence") and exogenous fluorophores. LIF is applied for clinical diagnosis in dermatology, gynaecology, urology, lung tumors as well as for early dentin caries. We describe the analysers with He-Ne, He-Cd, and SHG Nd:YAG lasers and new generation systems based on blue semiconductor GaN lasers that have been implemented into clinical practice till now. The LIF method, fundamental one for many medical applications, with excitation radiation of wavelength 400 nm could be appl,ied only using tunable dye lasers or titanium lasers adequte for laboratory investigations. Development of GaN laser shows possibility to design portable, compact diagnostic devices as multi-channel analysers of fluorescence spectra and surface imaging devoted to clinical application. The designed systems used for spectra measurement and registration of fluorescence images include lasers of power 5-30 mW and generate wavelengths of 405-407 nm. They are widely used in PDT method for investigation of superficial distribution of accumulation kinetics of all known photosensitizers, their elimination, and degradation as well as for treatment of superficial lesions of mucosa and skin. Excitation of exogenous porphrins in Soret band makes possible to estimate their concentration and a period of healthy skin photosensitivity that occurs after photosensitiser injections. Due to high sensitivity of spectrum analysers, properties of photosensitisers can be investigated in vitro (e.g. their aggregation, purity, chromatographic distributions) when their concentrations are 2-3 times lower in comparison to concentrations investigated with typical spectrofluorescence methods. Dentistry diagnosis is a new field in which GaN laser devices can be applied. After induction with blue light, decreased autofluorescence intensity can be observed when dentin caries occur and strong characteristic bands of endogenous porphyrines

  19. The Computational Challenges of Medical Imaging

    DTIC Science & Technology

    2004-02-01

    JASON will undertake a study for the DOE and the NIH National Institute for Bio- medical Imaging and Bio-engineering on the role of computation...broadly defined to include raw computational capabilities, mass storage needs, and connectivity) for medical imaging . This study will address the

  20. The Pediatric Urinary Tract and Medical Imaging.

    PubMed

    Penny, Steven M

    2016-01-01

    The pediatric urinary tract often is assessed with medical imaging. Consequently, it is essential for medical imaging professionals to have a fundamental understanding of pediatric anatomy, physiology, and common pathology of the urinary tract to provide optimal patient care. This article provides an overview of fetal development, pediatric urinary anatomy and physiology, and common diseases and conditions of the pediatric urinary tract.

  1. 4D Printing of Shape Memory-Based Personalized Endoluminal Medical Devices.

    PubMed

    Zarek, Matt; Mansour, Nicola; Shapira, Shir; Cohn, Daniel

    2017-01-01

    The convergence of additive manufacturing and shape-morphing materials is promising for the advancement of personalized medical devices. The capability to transform 3D objects from one shape to another, right off the print bed, is known as 4D printing. Shape memory thermosets can be tailored to have a range of thermomechanical properties favorable to medical devices, but processing them is a challenge because they are insoluble and do not flow at any temperature. This study presents here a strategy to capitalize on a series of medical imaging modalities to construct a printable shape memory endoluminal device, exemplified by a tracheal stent. A methacrylated polycaprolactone precursor with a molecular weight of 10 000 g mol(-1) is printed with a UV-LED stereolithography printer based on anatomical data. This approach converges with the zeitgeist of personalized medicine and it is anticipated that it will broadly expand the application of shape memory-exhibiting biomedical devices to myriad clinical indications.

  2. Medical devices manufactured from latex: European regulatory initiatives.

    PubMed

    De Jong, W H; Geertsma, R E; Tinkler, J J B

    2002-05-01

    In Europe the marketing of medical devices manufactured from latex is regulated by directives describing the essential (safety) requirements that products have to fulfill to obtain marketing approval. This paper describes the general requirements for marketing medical devices in Europe and, more specifically, the requirements for products manufactured from natural rubber latex. The requirements for marketing medical devices can be fulfilled by using the relevant harmonized European standards. These standards are regularly under revision to incorporate the latest scientific developments. For certain devices, for example, latex medical (examination and surgical) gloves, specific standards have been published. Medical devices manufactured from latex pose a serious problem because of the risk of induction of allergy both against the latex proteins inherently present (type I or immediate type allergy) and against chemicals added during processing (type IV or delayed type hypersensitivity) present as residues in the latex products. So, besides requirements for product quality in terms of barrier properties, strength, and sterility, the main focus consists of the allergy-inducing properties of the latex products. Recent developments have reopened the discussion on the value of total protein versus allergen determination in latex medical gloves. However, as long as minimal levels needed for both sensitization and elicitation have not been established, a safe maximum level for leachable proteins/allergens in latex products cannot be determined. A European Commission guidance document on the latex allergy problem is currently being drafted by experts from Competent Authorities.

  3. Robust Light Filters Support Powerful Imaging Devices

    NASA Technical Reports Server (NTRS)

    2009-01-01

    Infrared (IR) light filters developed by Lake Shore Cryotronics Inc. of Westerville, Ohio -- using SBIR funding from NASA s Jet Propulsion Laboratory and Langley Research Center -- employ porous silicon and metal mesh technology to provide optical filtration even at the ultra-low temperatures required by many IR sensors. With applications in the astronomy community, Lake Shore s SBIR-developed filters are also promising tools for use in terahertz imaging, the next wave of technology for applications like medical imaging, the study of fragile artworks, and airport security.

  4. Design Engineering of Biomaterials for Medical Devices

    NASA Astrophysics Data System (ADS)

    Hill, David

    1998-10-01

    Written by an exceptionally experienced author in the area of medical equipment product design, this text presents a comprehensive overview of such sound principles and state-of-the-art techniques covering a whole host of material types, biocompatability, the design process and future trends within this exciting field. An all-in-one reference text, concise and easy-to-read. Wide audience appeal, from industry professionals to students of design.

  5. Quality management for the processing of medical devices

    PubMed Central

    Klosz, Kerstin

    2008-01-01

    Rules on the reprocessing of medical devices were put into place in Germany in 2001. The present article explains the background situation and the provisions that are currently in force. The implementation of these statutory requirements is described using the example of the quality management system of Germany’s market leader, Vanguard AG. This quality management system was successfully certified pursuant to DIN EN ISO 13485:2003 for the scope "reprocessing of medical devices", including class “critical C”, in accordance with the recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert-Koch-Institute (RKI) and the German Federal Institute for Drugs and Medical Devices (BfArM) on the “Hygiene requirements for reprocessing of medical devices”. PMID:20204094

  6. Design considerations for medical devices in the home environment.

    PubMed

    Kaufman-Rivi, Diana; Collins-Mitchell, Janette; Jetley, Raoul

    2010-01-01

    Patient demographics, economic forces, and technological advancements contribute to the rise in home care services. Advanced medical devices and equipment originally designed for use by trained personnel in hospitals and clinics are increasingly migrating into the home. Unlike the clinical setting, the home is an uncontrolled environment with additional hazards. The compatibility of the device with the recipient's knowledge, abilities, lifestyle, and home environment plays a significant role in their therapy and rehabilitation. The advent of new device technologies such as wireless devices and interoperability of systems lends a new and complex perspective for medical device use in the home that must also be addressed. Adequately assessing and matching the patient and their caregiver with the appropriate device technology while considering the suitability of the home environment for device operation and maintenance is a challenge that relies on good human factors principles. There is a need to address these challenges in the growing home care sector In this article, the authors take a look at some important considerations and design issues for medical devices used in the home care environment.

  7. Medical device development: managing conflicts of interest encountered by physicians.

    PubMed

    Baim, Donald S; Donovan, Aine; Smith, John J; Briefs, Nancy; Geoffrion, Richard; Feigal, David; Kaplan, Aaron V

    2007-04-01

    New technologies introduced over the past three decades have transformed medical diagnosis and treatment, and significantly improved patient outcomes. These changes have been mediated by the introduction of new medical devices, particularly for the treatment of cardiovascular, orthopedic, and ophthalmic disorders. These devices, in turn, have created large markets and spawned a burgeoning medical device industry, including six Fortune 500 companies whose combined market capitalization now exceeds 400 billion dollars. This success story, which has unquestionably benefited patients and society alike, has been dependent upon an intense collaboration among industry, clinicians, and regulatory authorities. However, when physicians actively involved in patient care participate in such collaborations, they are increasingly vulnerable to creating potential conflicts between these two (clinical and device development) roles. Such conflicts, which may ultimately erode public trust, have important consequences not only for the individual physicians, but also for their parent institutions, their patients, sponsoring companies, and the entire clinical research enterprise that makes the development and introduction of new devices possible. The third Dartmouth Device Development Symposium held in October 2005 brought together thought leaders within the medical device community, including academicians, clinical investigators, regulators from the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS), large and small device manufacturers and the financial (venture capital and investment banks) community. The Symposium examined the conflicts of interest encountered during the early development and commercialization of a medical device. The goal of these discussions was to (1) identify and characterize the conflicts that arise and (2) provide strategies to address these conflicts. This manuscript was prepared by a writing committee to provide a summary

  8. The algorithm stitching for medical imaging

    NASA Astrophysics Data System (ADS)

    Semenishchev, E.; Marchuk, V.; Voronin, V.; Pismenskova, M.; Tolstova, I.; Svirin, I.

    2016-05-01

    In this paper we propose a stitching algorithm of medical images into one. The algorithm is designed to stitching the medical x-ray imaging, biological particles in microscopic images, medical microscopic images and other. Such image can improve the diagnosis accuracy and quality for minimally invasive studies (e.g., laparoscopy, ophthalmology and other). The proposed algorithm is based on the following steps: the searching and selection areas with overlap boundaries; the keypoint and feature detection; the preliminary stitching images and transformation to reduce the visible distortion; the search a single unified borders in overlap area; brightness, contrast and white balance converting; the superimposition into a one image. Experimental results demonstrate the effectiveness of the proposed method in the task of image stitching.

  9. Image analysis in medical imaging: recent advances in selected examples

    PubMed Central

    Dougherty, G

    2010-01-01

    Medical imaging has developed into one of the most important fields within scientific imaging due to the rapid and continuing progress in computerised medical image visualisation and advances in analysis methods and computer-aided diagnosis. Several research applications are selected to illustrate the advances in image analysis algorithms and visualisation. Recent results, including previously unpublished data, are presented to illustrate the challenges and ongoing developments. PMID:21611048

  10. Content standards for medical image metadata

    NASA Astrophysics Data System (ADS)

    d'Ornellas, Marcos C.; da Rocha, Rafael P.

    2003-12-01

    Medical images are at the heart of the healthcare diagnostic procedures. They have provided not only a noninvasive mean to view anatomical cross-sections of internal organs but also a mean for physicians to evaluate the patient"s diagnosis and monitor the effects of the treatment. For a Medical Center, the emphasis may shift from the generation of image to post processing and data management since the medical staff may generate even more processed images and other data from the original image after various analyses and post processing. A medical image data repository for health care information system is becoming a critical need. This data repository would contain comprehensive patient records, including information such as clinical data and related diagnostic images, and post-processed images. Due to the large volume and complexity of the data as well as the diversified user access requirements, the implementation of the medical image archive system will be a complex and challenging task. This paper discusses content standards for medical image metadata. In addition it also focuses on the image metadata content evaluation and metadata quality management.

  11. Medical devices; radiology devices; reclassification of full-field digital mammography system. Final rule.

    PubMed

    2010-11-05

    The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." FDA is reclassifying the device into class II (special controls) because general controls along with special controls will provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

  12. A survey of medical diagnostic imaging technologies

    SciTech Connect

    Heese, V.; Gmuer, N.; Thomlinson, W.

    1991-10-01

    The fields of medical imaging and medical imaging instrumentation are increasingly important. The state-of-the-art continues to advance at a very rapid pace. In fact, various medical imaging modalities are under development at the National Synchrotron Light Source (such as MECT and Transvenous Angiography.) It is important to understand how these techniques compare with today`s more conventional imaging modalities. The purpose of this report is to provide some basic information about the various medical imaging technologies currently in use and their potential developments as a basis for this comparison. This report is by no means an in-depth study of the physics and instrumentation of the various imaging modalities; instead, it is an attempt to provide an explanation of the physical bases of these techniques and their principal clinical and research capabilities.

  13. A survey of medical diagnostic imaging technologies

    SciTech Connect

    Heese, V.; Gmuer, N.; Thomlinson, W.

    1991-10-01

    The fields of medical imaging and medical imaging instrumentation are increasingly important. The state-of-the-art continues to advance at a very rapid pace. In fact, various medical imaging modalities are under development at the National Synchrotron Light Source (such as MECT and Transvenous Angiography.) It is important to understand how these techniques compare with today's more conventional imaging modalities. The purpose of this report is to provide some basic information about the various medical imaging technologies currently in use and their potential developments as a basis for this comparison. This report is by no means an in-depth study of the physics and instrumentation of the various imaging modalities; instead, it is an attempt to provide an explanation of the physical bases of these techniques and their principal clinical and research capabilities.

  14. Medical devices; exemption from premarket notification and reserved devices; Class I--FDA. Proposed rule.

    PubMed

    1998-11-12

    The Food and Drug Administration (FDA) is proposing to amend its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is proposing to designate as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA.

  15. [Regulation of medical devices in the Region of the Americas].

    PubMed

    Enríquez, Nilda; Álvarez, Yadira; Martínez, Dulce María; Pérez, Ana; Lemgruber, Alexandre

    2016-05-01

    Objective To describe and analyze the current status of and the challenges involved in the regulation of medical devices in the Region of the Americas and to present the results of the regional mapping exercise, progress toward the development of advanced assessment indicators, and the achievements of the Regional Working Group. Methods Creating a regional profile on the regulation of medical devices in the Americas is a priority for the Working Group. To this end a tool composed of 45 questions organized into six sections was developed and distributed among 15 countries for self-assessment (the participation rate was 100%). Based on the data received, nine basic indicators were established and an agreement was reached to develop advanced indicators for measuring the extent to which regulatory programs for medical devices were being implemented. Results Of the 15 countries, 93% have an agency in charge of regulating medical devices. An analysis of individual country performance shows wide variability, with some countries meeting all indicators and others meeting as few as 11%. The mapping also made it possible to generate information on collaborative partnerships, training, and regulation. Conclusions The results show significant heterogeneity at the regional level. Implementation of advanced indicators will help to identify areas of opportunity and strengths for the development of the regulatory profile. Although progress has been made toward strengthening regulatory programs for medical devices, remaining gaps need to be bridged through strategies and initiatives to be led by the Working Group.

  16. 76 FR 36993 - Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... classification for human dura mater. This action is being taken to improve the accuracy of the regulations. DATES... HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 (formerly Docket No. 1997N-0484P) Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater; Technical Amendment...

  17. 77 FR 16925 - Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-23

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying the Near Infrared (NIR)...

  18. 78 FR 13347 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...

  19. 75 FR 9422 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-02

    ... HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical... Administration ] (FDA). The meeting will be open to the public. Name of Committee: Orthopaedic and Rehabilitation... CS is not a prosthetic device and is not intended to replace normal body structure. FDA intends to...

  20. 78 FR 19717 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule AGENCY: Food and Drug...

  1. 76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery... PLASTIC SURGERY DEVICES 0 1. The authority citation for 21 CFR part 878 continues to read as...

  2. 76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food and...

  3. 77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents; Correction AGENCY: Food and Drug Administration...

  4. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6... provision by nongovernmental organizations that are U.S. persons of in-kind donations of medicine,...

  5. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of...

  6. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of...

  7. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6... provision by nongovernmental organizations that are U.S. persons of in-kind donations of medicine,...

  8. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of...

  9. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6... provision by nongovernmental organizations that are U.S. persons of in-kind donations of medicine,...

  10. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6... provision by nongovernmental organizations that are U.S. persons of in-kind donations of medicine,...

  11. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of...

  12. Image registration method for medical image sequences

    DOEpatents

    Gee, Timothy F.; Goddard, James S.

    2013-03-26

    Image registration of low contrast image sequences is provided. In one aspect, a desired region of an image is automatically segmented and only the desired region is registered. Active contours and adaptive thresholding of intensity or edge information may be used to segment the desired regions. A transform function is defined to register the segmented region, and sub-pixel information may be determined using one or more interpolation methods.

  13. [Image fusion in medical radiology].

    PubMed

    Burger, C

    1996-07-20

    Image fusion supports the correlation between images of two or more studies of the same organ. First, the effect of differing geometries during image acquisitions, such as a head tilt, is compensated for. As a consequence, congruent images can easily be obtained. Instead of merely putting them side by side in a static manner and burdening the radiologist with the whole correlation task, image fusion supports him with interactive visualization techniques. This is especially worthwhile for small lesions as they can be more precisely located. Image fusion is feasible today. Easy and robust techniques are readily available, and furthermore DICOM, a rapidly evolving data exchange standard, diminishes the once severe compatibility problems for image data originating from systems of different manufacturers. However, the current solutions for image fusion are not yet established enough for a high throughput of fusion studies. Thus, for the time being image fusion is most appropriately confined to clinical research studies.

  14. Medical imaging in new drug clinical development.

    PubMed

    Wang, Yi-Xiang; Deng, Min

    2010-12-01

    Medical imaging can help answer key questions that arise during the drug development process. The role of medical imaging in new drug clinical trials includes identification of likely responders; detection and diagnosis of lesions and evaluation of their severity; and therapy monitoring and follow-up. Nuclear imaging techniques such as PET can be used to monitor drug pharmacokinetics and distribution and study specific molecular endpoints. In assessing drug efficacy, imaging biomarkers and imaging surrogate endpoints can be more objective and faster to measure than clinical outcomes, and allow small group sizes, quick results and good statistical power. Imaging also has important role in drug safety monitoring, particularly when there is no other suitable biomarkers available. Despite the long history of radiological sciences, its application to the drug development process is relatively recent. This review highlights the processes, opportunities, and challenges of medical imaging in new drug development.

  15. Denoising Medical Images using Calculus of Variations.

    PubMed

    Kohan, Mahdi Nakhaie; Behnam, Hamid

    2011-07-01

    We propose a method for medical image denoising using calculus of variations and local variance estimation by shaped windows. This method reduces any additive noise and preserves small patterns and edges of images. A pyramid structure-texture decomposition of images is used to separate noise and texture components based on local variance measures. The experimental results show that the proposed method has visual improvement as well as a better SNR, RMSE and PSNR than common medical image denoising methods. Experimental results in denoising a sample Magnetic Resonance image show that SNR, PSNR and RMSE have been improved by 19, 9 and 21 percents respectively.

  16. Content-Based Medical Image Retrieval

    NASA Astrophysics Data System (ADS)

    Müller, Henning; Deserno, Thomas M.

    This chapter details the necessity for alternative access concepts to the currently mainly text-based methods in medical information retrieval. This need is partly due to the large amount of visual data produced, the increasing variety of medical imaging data and changing user patterns. The stored visual data contain large amounts of unused information that, if well exploited, can help diagnosis, teaching and research. The chapter briefly reviews the history of image retrieval and its general methods before technologies that have been developed in the medical domain are focussed. We also discuss evaluation of medical content-based image retrieval (CBIR) systems and conclude with pointing out their strengths, gaps, and further developments. As examples, the MedGIFT project and the Image Retrieval in Medical Applications (IRMA) framework are presented.

  17. Medical image analysis with artificial neural networks.

    PubMed

    Jiang, J; Trundle, P; Ren, J

    2010-12-01

    Given that neural networks have been widely reported in the research community of medical imaging, we provide a focused literature survey on recent neural network developments in computer-aided diagnosis, medical image segmentation and edge detection towards visual content analysis, and medical image registration for its pre-processing and post-processing, with the aims of increasing awareness of how neural networks can be applied to these areas and to provide a foundation for further research and practical development. Representative techniques and algorithms are explained in detail to provide inspiring examples illustrating: (i) how a known neural network with fixed structure and training procedure could be applied to resolve a medical imaging problem; (ii) how medical images could be analysed, processed, and characterised by neural networks; and (iii) how neural networks could be expanded further to resolve problems relevant to medical imaging. In the concluding section, a highlight of comparisons among many neural network applications is included to provide a global view on computational intelligence with neural networks in medical imaging. Copyright © 2010 Elsevier Ltd. All rights reserved.

  18. Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record.

    PubMed

    Jang, Hye Jung; Choi, Young Deuk; Kim, Nam Hyun

    2017-04-01

    This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude, potential benefits, and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction, but relatively low for time-consuming and decision-making. We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.

  19. Economic content in medical journal advertisements for medical devices and prescription drugs.

    PubMed

    Ackerly, D Clay; Glickman, Seth W; Schulman, Kevin A

    2010-01-01

    Previous studies of economic content in medical journal advertisements have not examined all types of economic content and have not included advertisements for medical devices. To examine trends in the economic content of medical device and pharmaceutical advertisements in medical journals. Three reviewers examined pharmaceutical and medical device advertisements in six leading medical journals from 1997 through 2006. Product characteristics, economic claims and evidence to support those claims were evaluated. Economic content appeared in 23.5% (561/2389) of pharmaceutical and device advertisements; 11.9% made market share claims and 12.7% made other economic claims. From 1997 through 2006, the percentage of medical device advertisements containing economic content declined from 26.7% to 6.7% (p = 0.02), whereas the percentage of pharmaceutical advertisements containing economic content remained stable (21.6-22.0%; p = 0.99). For pharmaceuticals, price claims declined significantly (15.7-4.2%; p < 0.01) and market share claims increased (2.8-11.5%; p = 0.09), and both consistently presented evidence (83% and 98%, respectively) while other types did not (e.g. 13.5% of formulary claims). Medical device economic claims differed from pharmaceutical economic claims; they made fewer market share claims (1.1% vs 12.8%) but more cost-effectiveness (6.5% vs 0.6%) and reimbursement (4.9% vs 0.8%) claims. Fewer than 2% of device advertisements with economic claims provided supporting evidence. The prevalence and type of economic content in pharmaceutical and device advertisements changed between 1997 and 2006, which may reflect evolving market dynamics, such as changes in reimbursement systems. Furthermore, the lack of supporting evidence in medical device advertisements and pharmaceutical formulary claims are potential areas of concern that require additional scrutiny by regulators and journal editors.

  20. Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record

    PubMed Central

    Jang, Hye Jung; Choi, Young Deuk

    2017-01-01

    Objectives This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Methods Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Results Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude, potential benefits, and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction, but relatively low for time-consuming and decision-making. Conclusions We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management. PMID:28523207

  1. Transmitting patient and device data via GSM--central management for decentral mobile medical devices.

    PubMed

    Bachmor, T; Schöchlin, J; Bolz, A

    2002-01-01

    Equipping medical devices with long range telemetry opens completely new possibilities for emergency response, home care and remote diagnosis. Mobile communications nowadays seem to be a generally accepted part of our modern world, but bridging the gap between new (consumer-) technologies and medical devices still is a challenge today. Providing a telemetry link (GSM) is just the trivial part--ensuring security, reliability and service management are the more critical tasks that need to be addressed. Therefore, a complete system concept consists of an automatic fleet management (e.g. periodic device-initiated service calls) as well as customer relationship management (CRM), including technical service and a trouble-ticket system.

  2. Stakeholder challenges in purchasing medical devices for patient safety.

    PubMed

    Hinrichs, Saba; Dickerson, Terry; Clarkson, John

    2013-03-01

    This study identifies the stakeholders who have a role in medical device purchasing within the wider system of health-care delivery and reports on their particular challenges to promote patient safety during purchasing decisions. Data was collected through observational work, participatory workshops, and semi-structured qualitative interviews, which were analyzed and coded. The study takes a systems-based and engineering design approach to the study. Five hospitals took part in this study, and the participants included maintenance, training, clinical end-users, finance, and risk departments. The main stakeholders for purchasing were identified to be staff from clinical engineering (Maintenance), device users (Clinical), device trainers (Training), and clinical governance for analyzing incidents involving devices (Risk). These stakeholders display varied characteristics in terms of interpretation of their own roles, competencies for selecting devices, awareness and use of resources for purchasing devices, and attitudes toward the purchasing process. The role of "clinical engineering" is seen by these stakeholders to be critical in mediating between training, technical, and financial stakeholders but not always recognized in practice. The findings show that many device purchasing decisions are tackled in isolation, which is not optimal for decisions requiring knowledge that is currently distributed among different people within different departments. The challenges expressed relate to the wider system of care and equipment management, calling for a more systemic view of purchasing for medical devices.

  3. Study of the in vitro cytotoxicity testing of medical devices.

    PubMed

    Li, Weijia; Zhou, Jing; Xu, Yuyin

    2015-09-01

    The cytotoxicity test is one of the biological evaluation and screening tests that use tissue cells in vitro to observe the cell growth, reproduction and morphological effects by medical devices. Cytotoxicity is preferred as a pilot project test and an important indicator for toxicity evaluation of medical devices as it is simple, fast, has a high sensitivity and can save animals from toxicity. Three types of cytotoxicity test are stated in the International Organization for Standardization 109993-5: Extract, direct contact and indirect contact tests. The xCELLigence real-time cell analysis system shows a significant potential in regards to cytotoxicity in recent years. The present review provides a brief insight into the in vitro cytotoxicity testing of medical devices.

  4. Study of the in vitro cytotoxicity testing of medical devices

    PubMed Central

    LI, WEIJIA; ZHOU, JING; XU, YUYIN

    2015-01-01

    The cytotoxicity test is one of the biological evaluation and screening tests that use tissue cells in vitro to observe the cell growth, reproduction and morphological effects by medical devices. Cytotoxicity is preferred as a pilot project test and an important indicator for toxicity evaluation of medical devices as it is simple, fast, has a high sensitivity and can save animals from toxicity. Three types of cytotoxicity test are stated in the International Organization for Standardization 109993-5: Extract, direct contact and indirect contact tests. The xCELLigence real-time cell analysis system shows a significant potential in regards to cytotoxicity in recent years. The present review provides a brief insight into the in vitro cytotoxicity testing of medical devices. PMID:26405534

  5. Developing medical device software in compliance with regulations.

    PubMed

    Zema, M; Rosati, S; Gioia, V; Knaflitz, M; Balestra, G

    2015-08-01

    In the last decade, the use of information technology (IT) in healthcare has taken a growing role. In fact, the adoption of an increasing number of computer tools has led to several benefits related to the process of patient care and allowed easier access to social and health care resources. At the same time this trend gave rise to new challenges related to the implementation of these new technologies. Software used in healthcare can be classified as medical devices depending on the way they are used and on their functional characteristics. If they are classified as medical devices they must satisfy specific regulations. The aim of this work is to present a software development framework that can allow the production of safe and high quality medical device software and to highlight the correspondence between each software development phase and the appropriate standard and/or regulation.

  6. Microwave impedance imaging on semiconductor memory devices

    NASA Astrophysics Data System (ADS)

    Kundhikanjana, Worasom; Lai, Keji; Yang, Yongliang; Kelly, Michael; Shen, Zhi-Xun

    2011-03-01

    Microwave impedance microscopy (MIM) maps out the real and imaginary components of the tip-sample impedance, from which the local conductivity and dielectric constant distribution can be derived. The stray field contribution is minimized in our shielded cantilever design, enabling quantitative analysis of nano-materials and device structures. We demonstrate here that the MIM can spatially resolve the conductivity variation in a dynamic random access memory (DRAM) sample. With DC or low-frequency AC bias applied to the tip, contrast between n-doped and p-doped regions in the dC/dV images is observed, and p-n junctions are highlighted in the dR/dV images. The results can be directly compared with data taken by scanning capacitance microscope (SCM), which uses unshielded cantilevers and resonant electronics, and the MIM reveals more information of the local dopant concentration than SCM.

  7. Medical Devices; Cardiovascular Devices; Classification of the Coronary Vascular Physiologic Simulation Software Device. Final order.

    PubMed

    2015-10-21

    The Food and Drug Administration (FDA) is classifying the coronary vascular physiologic simulation software device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the coronary vascular physiologic simulation software device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

  8. Medical image libraries: ICoS project

    NASA Astrophysics Data System (ADS)

    Honniball, John; Thomas, Peter

    1999-08-01

    FOr use of digital techniques for the production, manipulation and storage of images has resulted in the creation of digital image libraries. These libraries often store many thousands of images. While provision of storage media for such large amounts of data has been straightforward, provision of effective searching and retrieval tools has not. Medicine relies heavily on images as a diagnostic tool. The most obvious example is the x-ray, but many other image forms are in everyday use. Advances in technology are affecting the ways medical images are generated, stored and retrieved. The paper describes the work of the Image COding and Segmentation to Support Variable Rate Transmission Channels and Variable Resolution Platforms (ICoS) research project currently under way in Bristol, UK. ICoS is a project of the Mobile of England and Hewlett-Packard Research Laboratories Europe. Funding is provided by the Engineering and PHysical Sciences Research Council. The aim of the ICoS project is to demonstrate the practical application of computer networking to medical image libraries. Work at the University of the West of England concentrates on user interface and indexing issues. Metadata is used to organize the images, coded using the WWW Consortium standard Resource Description Framework. We are investigating the application of such standards to medical images, one outcome being to implement a metadata-based image library. This paper describes the ICoS project in detail and discuses both metadata system and user interfaces in the context of medical applications.

  9. Medical devices early assessment methods: systematic literature review.

    PubMed

    Markiewicz, Katarzyna; van Til, Janine A; IJzerman, Maarten J

    2014-04-01

    The aim of this study was to get an overview of current theory and practice in early assessments of medical devices, and to identify aims and uses of early assessment methods used in practice. A systematic literature review was conducted in September 2013, using computerized databases (PubMed, Science Direct, and Scopus), and references list search. Selected articles were categorized based on their type, objective, and main target audience. The methods used in the application studies were extracted and mapped throughout the early stages of development and for their particular aims. Of 1,961 articles identified, eighty-three studies passed the inclusion criteria, and thirty were included by searching reference lists. There were thirty-one theoretical papers, and eighty-two application papers included. Most studies investigated potential applications/possible improvement of medical devices, developed early assessment framework or included stakeholder perspective in early development stages. Among multiple qualitative and quantitative methods identified, only few were used more than once. The methods aim to inform strategic considerations (e.g., literature review), economic evaluation (e.g., cost-effectiveness analysis), and clinical effectiveness (e.g., clinical trials). Medical devices were often in the prototype product development stage, and the results were usually aimed at informing manufacturers. This study showed converging aims yet widely diverging methods for early assessment during medical device development. For early assessment to become an integral part of activities in the development of medical devices, methods need to be clarified and standardized, and the aims and value of assessment itself must be demonstrated to the main stakeholders for assuring effective and efficient medical device development.

  10. Determining optimal medical image compression: psychometric and image distortion analysis

    PubMed Central

    2012-01-01

    Background Storage issues and bandwidth over networks have led to a need to optimally compress medical imaging files while leaving clinical image quality uncompromised. Methods To determine the range of clinically acceptable medical image compression across multiple modalities (CT, MR, and XR), we performed psychometric analysis of image distortion thresholds using physician readers and also performed subtraction analysis of medical image distortion by varying degrees of compression. Results When physician readers were asked to determine the threshold of compression beyond which images were clinically compromised, the mean image distortion threshold was a JPEG Q value of 23.1 ± 7.0. In Receiver-Operator Characteristics (ROC) plot analysis, compressed images could not be reliably distinguished from original images at any compression level between Q = 50 and Q = 95. Below this range, some readers were able to discriminate the compressed and original images, but high sensitivity and specificity for this discrimination was only encountered at the lowest JPEG Q value tested (Q = 5). Analysis of directly measured magnitude of image distortion from subtracted image pairs showed that the relationship between JPEG Q value and degree of image distortion underwent an upward inflection in the region of the two thresholds determined psychometrically (approximately Q = 25 to Q = 50), with 75 % of the image distortion occurring between Q = 50 and Q = 1. Conclusion It is possible to apply lossy JPEG compression to medical images without compromise of clinical image quality. Modest degrees of compression, with a JPEG Q value of 50 or higher (corresponding approximately to a compression ratio of 15:1 or less), can be applied to medical images while leaving the images indistinguishable from the original. PMID:22849336

  11. Determining optimal medical image compression: psychometric and image distortion analysis.

    PubMed

    Flint, Alexander C

    2012-07-31

    Storage issues and bandwidth over networks have led to a need to optimally compress medical imaging files while leaving clinical image quality uncompromised. To determine the range of clinically acceptable medical image compression across multiple modalities (CT, MR, and XR), we performed psychometric analysis of image distortion thresholds using physician readers and also performed subtraction analysis of medical image distortion by varying degrees of compression. When physician readers were asked to determine the threshold of compression beyond which images were clinically compromised, the mean image distortion threshold was a JPEG Q value of 23.1 ± 7.0. In Receiver-Operator Characteristics (ROC) plot analysis, compressed images could not be reliably distinguished from original images at any compression level between Q = 50 and Q = 95. Below this range, some readers were able to discriminate the compressed and original images, but high sensitivity and specificity for this discrimination was only encountered at the lowest JPEG Q value tested (Q = 5). Analysis of directly measured magnitude of image distortion from subtracted image pairs showed that the relationship between JPEG Q value and degree of image distortion underwent an upward inflection in the region of the two thresholds determined psychometrically (approximately Q = 25 to Q = 50), with 75 % of the image distortion occurring between Q = 50 and Q = 1. It is possible to apply lossy JPEG compression to medical images without compromise of clinical image quality. Modest degrees of compression, with a JPEG Q value of 50 or higher (corresponding approximately to a compression ratio of 15:1 or less), can be applied to medical images while leaving the images indistinguishable from the original.

  12. [Radiotherapy and implantable medical device: example of infusion pumps].

    PubMed

    Abrous-Anane, S; Benhassine, S; Lopez, S; Cristina, K; Mazeron, J-J

    2013-12-01

    Indication for radiotherapy is often questioned for patients equipped with implantable medical devices like infusion pumps as the radiation tolerance is poor or not known. We report here on the case of a patient who we treated with pelvic radiotherapy for cervical cancer and who had an infusion pump in iliac fossa. We conducted a series of tests on five identical pumps that insured that the treatment protocol is harmless to the implanted device.

  13. Enabling Medical Device Interoperability for the Integrated Clinical Environment

    DTIC Science & Technology

    2016-12-01

    the White House CTO, HHS, and standards bodies for improving the clock time accuracy of medical device data transmitted to EHRs, and the 2014-2015...ICE): Particular requirements for the forensic data logger. We decided that taking time to write the draft standard would be valuable in identifying...device and software companies , computer scientists, clinicians, and standards developers. The insights obtained from our research were shared in those

  14. Medical devices and procedures in the hyperbaric chamber.

    PubMed

    Kot, Jacek

    2014-12-01

    The aim of this paper is to present current controversies concerning the safety of medical devices and procedures under pressure in a hyperbaric chamber including: defibrillation in a multiplace chamber; implantable devices during hyperbaric oxygen treatment (HBOT) and the results of a recent European questionnaire on medical devices used inside hyperbaric chambers. Early electrical defibrillation is the only effective therapy for cardiac arrest caused by ventricular fibrillation or pulseless ventricular tachycardia. The procedure of defibrillation under hyperbaric conditions is inherently dangerous owing to the risk of fire, but it can be conducted safely if certain precautions are taken. Recently, new defibrillators have been introduced for hyperbaric medicine, which makes the procedure easier technically, but it must be noted that sparks and fire have been observed during defibrillation, even under normobaric conditions. Therefore, delivery of defibrillation shock in a hyperbaric environment must still be perceived as a hazardous procedure. Implantable devices are being seen with increasing frequency in patients referred for HBOT. These devices create a risk of malfunction when exposed to hyperbaric conditions. Some manufacturers support patients and medical practitioners with information on how their devices behave under increased pressure, but in some cases an individual risk-benefit analysis should be conducted on the patient and the specific implanted device, taking into consideration the patient's clinical condition, the indication for HBOT and the capability of the HBOT facility for monitoring and intervention in the chamber. The results of the recent survey on use of medical devices inside European hyperbaric chambers are also presented. A wide range of non-CE-certified equipment is used in European chambers.

  15. [M-health: trends in wearable medical devices].

    PubMed

    Teng, Xiao-fei; Zhang, Yuan-Ting

    2006-09-01

    This paper focuses on the trends in wearable medical devices for the applications in m-health. The state-of-art technologies for the continuous and noninvasive measurements of physiological parameters, implementation platforms of wearable medical devices - e-textile, and body sensor networks are reviewed here with examples of related recent research projects conducted in different countries. In addition, we introduce our recent research project on the e-textile-based health shirt (h-shirt), which can measure arterial blood pressure noninvasively, continuously and cufflessly.

  16. Low power signal processing electronics for wearable medical devices.

    PubMed

    Casson, Alexander J; Rodriguez-Villegas, Esther

    2010-01-01

    Custom designed microchips, known as Application Specific Integrated Circuits (ASICs), offer the lowest possible power consumption electronics. However, this comes at the cost of a longer, more complex and more costly design process compared to one using generic, off-the-shelf components. Nevertheless, their use is essential in future truly wearable medical devices that must operate for long periods of time from physically small, energy limited batteries. This presentation will demonstrate the state-of-the-art in ASIC technology for providing online signal processing for use in these wearable medical devices.

  17. [Harm related to medical device use - legal and organisational risks].

    PubMed

    Hölscher, U M

    2014-12-01

    The effectiveness of the risk management systems established by medical device manufacturers and health-care facilities is clearly mitigated by European and national legal provisions. Laws, regulations and authorities prevent the systematic exchange of much safety-relevant information. The obligation to report adverse events is suspended for many relevant risks associated with medical device use. Reporting into the vigilance system is of little avail for users. Reporting even may endanger the information provider. The federal fragmentation of the German vigilance system poses a risk for patients. Risk management in health-care facilities without risk policy is dangerously incomplete.

  18. Smart alarms from medical devices in the OR and ICU.

    PubMed

    Imhoff, Michael; Kuhls, Silvia; Gather, Ursula; Fried, Roland

    2009-03-01

    Alarms in medical devices are a matter of concern in critical and perioperative care. The high rate of false alarms is not only a nuisance for patients and caregivers, but can also compromise patient safety and effectiveness of care. The development of alarm systems has lagged behind the technological advances of medical devices over the last 20 years. From a clinical perspective, major improvements in alarm algorithms are urgently needed. This review gives an overview of the current clinical situation and the underlying problems, and discusses different methods from statistics and computational science and their potential for clinical application. Some examples of the application of new alarm algorithms to clinical data are presented.

  19. [Industry regulation and its relationship to the rapid marketing of medical devices].

    PubMed

    Matsuoka, Atsuko

    2012-01-01

    In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices").

  20. THz Medical Imaging: in vivo Hydration Sensing

    PubMed Central

    Taylor, Zachary D.; Singh, Rahul S.; Bennett, David B.; Tewari, Priyamvada; Kealey, Colin P.; Bajwa, Neha; Culjat, Martin O.; Stojadinovic, Alexander; Lee, Hua; Hubschman, Jean-Pierre; Brown, Elliott R.; Grundfest, Warren S.

    2015-01-01

    The application of THz to medical imaging is experiencing a surge in both interest and federal funding. A brief overview of the field is provided along with promising and emerging applications and ongoing research. THz imaging phenomenology is discussed and tradeoffs are identified. A THz medical imaging system, operating at ~525 GHz center frequency with ~125 GHz of response normalized bandwidth is introduced and details regarding principles of operation are provided. Two promising medical applications of THz imaging are presented: skin burns and cornea. For burns, images of second degree, partial thickness burns were obtained in rat models in vivo over an 8 hour period. These images clearly show the formation and progression of edema in and around the burn wound area. For cornea, experimental data measuring the hydration of ex vivo porcine cornea under drying is presented demonstrating utility in ophthalmologic applications. PMID:26085958

  1. Elastomeric actuator devices for magnetic resonance imaging

    NASA Technical Reports Server (NTRS)

    Dubowsky, Steven (Inventor); Hafez, Moustapha (Inventor); Jolesz, Ferenc A. (Inventor); Kacher, Daniel F. (Inventor); Lichter, Matthew (Inventor); Weiss, Peter (Inventor); Wingert, Andreas (Inventor)

    2008-01-01

    The present invention is directed to devices and systems used in magnetic imaging environments that include an actuator device having an elastomeric dielectric film with at least two electrodes, and a frame attached to the actuator device. The frame can have a plurality of configurations including, such as, for example, at least two members that can be, but not limited to, curved beams, rods, plates, or parallel beams. These rigid members can be coupled to flexible members such as, for example, links wherein the frame provides an elastic restoring force. The frame preferably provides a linear actuation force characteristic over a displacement range. The linear actuation force characteristic is defined as .+-.20% and preferably 10% over a displacement range. The actuator further includes a passive element disposed between the flexible members to tune a stiffness characteristic of the actuator. The passive element can be a bi-stable element. The preferred embodiment actuator includes one or more layers of the elastomeric film integrated into the frame. The elastomeric film can be made of many elastomeric materials such as, for example, but not limited to, acrylic, silicone and latex.

  2. A Review of Simulators with Haptic Devices for Medical Training.

    PubMed

    Escobar-Castillejos, David; Noguez, Julieta; Neri, Luis; Magana, Alejandra; Benes, Bedrich

    2016-04-01

    Medical procedures often involve the use of the tactile sense to manipulate organs or tissues by using special tools. Doctors require extensive preparation in order to perform them successfully; for example, research shows that a minimum of 750 operations are needed to acquire sufficient experience to perform medical procedures correctly. Haptic devices have become an important training alternative and they have been considered to improve medical training because they let users interact with virtual environments by adding the sense of touch to the simulation. Previous articles in the field state that haptic devices enhance the learning of surgeons compared to current training environments used in medical schools (corpses, animals, or synthetic skin and organs). Consequently, virtual environments use haptic devices to improve realism. The goal of this paper is to provide a state of the art review of recent medical simulators that use haptic devices. In particular we focus on stitching, palpation, dental procedures, endoscopy, laparoscopy, and orthopaedics. These simulators are reviewed and compared from the viewpoint of used technology, the number of degrees of freedom, degrees of force feedback, perceived realism, immersion, and feedback provided to the user. In the conclusion, several observations per area and suggestions for future work are provided.

  3. [Regulatory Science in the Review of Drugs and Medical Devices].

    PubMed

    Koide, Akihiro

    2016-01-01

    The review of drugs and medical devices is an integral part of regulatory science. The Pharmaceuticals and Medical Devices Agency (PMDA) evaluates the efficacy, safety, and quality of drugs and medical devices after applications are submitted for regulatory approval. The products are approved when their benefits exceed their risks, i.e., an application is approved if the efficacy of the product in patients was demonstrated and the safety of the product is acceptable in view of its observed benefits. However, drugs and medical devices for which efficacy was not clearly demonstrated in clinical trials makes the decision to approve a difficult process. Under those circumstances, the approval process is based on the totality of information, such as the reason why clinical trials did not succeed and medical needs in Japan. The Wingspan stent system, which was approved for the treatment of intracranial arterial stenosis, is an example of a product with a use different from that intended by the US Food and Drug Administration and PMDA.

  4. Monitoring of Vital Signs with Flexible and Wearable Medical Devices.

    PubMed

    Khan, Yasser; Ostfeld, Aminy E; Lochner, Claire M; Pierre, Adrien; Arias, Ana C

    2016-06-01

    Advances in wireless technologies, low-power electronics, the internet of things, and in the domain of connected health are driving innovations in wearable medical devices at a tremendous pace. Wearable sensor systems composed of flexible and stretchable materials have the potential to better interface to the human skin, whereas silicon-based electronics are extremely efficient in sensor data processing and transmission. Therefore, flexible and stretchable sensors combined with low-power silicon-based electronics are a viable and efficient approach for medical monitoring. Flexible medical devices designed for monitoring human vital signs, such as body temperature, heart rate, respiration rate, blood pressure, pulse oxygenation, and blood glucose have applications in both fitness monitoring and medical diagnostics. As a review of the latest development in flexible and wearable human vitals sensors, the essential components required for vitals sensors are outlined and discussed here, including the reported sensor systems, sensing mechanisms, sensor fabrication, power, and data processing requirements.

  5. Aliphatic polyesters for medical imaging and theranostic applications.

    PubMed

    Nottelet, Benjamin; Darcos, Vincent; Coudane, Jean

    2015-11-01

    Medical imaging is a cornerstone of modern medicine. In that context the development of innovative imaging systems combining biomaterials and contrast agents (CAs)/imaging probes (IPs) for improved diagnostic and theranostic applications focuses intense research efforts. In particular, the classical aliphatic (co)polyesters poly(lactide) (PLA), poly(lactide-co-glycolide) (PLGA) and poly(ɛ-caprolactone) (PCL), attract much attention due to their long track record in the medical field. This review aims therefore at providing a state-of-the-art of polyester-based imaging systems. In a first section a rapid description of the various imaging modalities, including magnetic resonance imaging (MRI), optical imaging, computed tomography (CT), ultrasound (US) and radionuclide imaging (SPECT, PET) will be given. Then, the two main strategies used to combine the CAs/IPs and the polyesters will be discussed. In more detail we will first present the strategies relying on CAs/IPs encapsulation in nanoparticles, micelles, dendrimers or capsules. We will then present chemical modifications of polyesters backbones and/or polyester surfaces to yield macromolecular imaging agents. Finally, opportunities offered by these innovative systems will be illustrated with some recent examples in the fields of cell labeling, diagnostic or theranostic applications and medical devices.

  6. Modeling and Imaging Flexural Plate Wave Devices

    SciTech Connect

    Adkins, D.R.; Butler, M.A.; Chu, A.S.; Schubert, W.K.

    1999-07-09

    Sandia National Laboratories is developing a new form of flexural plate wave device (FPW) for sensor applications. In this device, Lorentz forces cause out of plane vibrations in a silicon nitride membrane. Current induced in transducer lines on the membrane provides information about the amplitude and phase of these surface vibrations. By tracking the large amplitude vibrations that occur at resonant frequencies, it is possible to infer information about loading on the membrane. In fabricating FPWs, it is important to understand the impact that minor defects can have on operation. Through modeling and testing, they are developing resilient designs that provide large amplitude signals with a high tolerance to defects. A finite element model has been developed to perform design trade-off studies, and results from the model are being verified with a unique measurement system that can image Angstrom scale displacements at vibrational frequencies up to 800 kHz. Results from FPW modeling and imaging efforts are presented in this paper.

  7. Medical Devices Assess, Treat Balance Disorders

    NASA Technical Reports Server (NTRS)

    2009-01-01

    series of dynamic protocols to isolate and assess balance function deficiencies. The technology was based on Nashner s novel, engineering-inspired concept of balance as an adaptable collaboration between multiple sensory and motor systems. CDP proved useful not only for examining astronauts, but for anyone suffering from balance problems. Today, CDP is the standard medical tool for objectively evaluating balance control.

  8. Battery power comparison to charge medical devices in developing countries.

    PubMed

    Casanova, Alesia M; Bray, Andrew S; Powers, Taylor A; Nimunkar, Amit J; Webster, John G

    2009-01-01

    Many people in developing countries cannot afford or rely on certain modes of electricity. We establish the reasonability of relying on lead-acid batteries, 9 V alkaline batteries, and lithium-ion batteries for charging low-voltage medical equipment. Based on the research and tests we conducted, we determined that using these battery types to charge medical devices truly is a reasonable solution.

  9. Human factors: should your medical devices require intensive care?

    PubMed

    Hyman, William A

    2010-06-01

    The design of a medical device should include active consideration of the way in which real users will actually use the device in the real environment of use. This consideration must include making the way in which the user interfaces with the device, for example, the buttons, the displays, the connections, such that the user can complete their tasks without error and without undue burden. This consideration of realistic user needs is addressed by the discipline of human factors. Copyright 2010 Elsevier Inc. All rights reserved.

  10. [Implanted medical device-related infections: pathophysiology and prevention].

    PubMed

    Lebeaux, David; Ghigo, Jean-Marc; Lucet, Jean-Christophe

    2014-05-01

    Medical progress led to an increase in the number of indications for indwelling devices. However, colonization of implanted devices by pathogenic microorganisms also increases risks of formation of microbial communities surrounded by an extracellular matrix called biofilms. Biofilms are able to survive in the presence of high concentrations of antimicrobials, therefore leading to treatment difficulties and exposing patients to the risk of infection recurrence. Because of these features, preventive measures reducing the risk of microbial contamination are cornerstone for the management of any patient carrying an indwelling device.

  11. 76 FR 55394 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... Collection; Comment Request; Medical Devices: Humanitarian Use Devices AGENCY: Food and Drug Administration... of information technology. Medical Devices: Humanitarian Use Devices--21 CFR Part 814 (OMB Control... to grant HUD designation of a medical device; (2) exempt an HUD from the effectiveness...

  12. Web-based medical image archive system

    NASA Astrophysics Data System (ADS)

    Suh, Edward B.; Warach, Steven; Cheung, Huey; Wang, Shaohua A.; Tangiral, Phanidral; Luby, Marie; Martino, Robert L.

    2002-05-01

    This paper presents a Web-based medical image archive system in three-tier, client-server architecture for the storage and retrieval of medical image data, as well as patient information and clinical data. The Web-based medical image archive system was designed to meet the need of the National Institute of Neurological Disorders and Stroke for a central image repository to address questions of stroke pathophysiology and imaging biomarkers in stroke clinical trials by analyzing images obtained from a large number of clinical trials conducted by government, academic and pharmaceutical industry researchers. In the database management-tier, we designed the image storage hierarchy to accommodate large binary image data files that the database software can access in parallel. In the middle-tier, a commercial Enterprise Java Bean server and secure Web server manages user access to the image database system. User-friendly Web-interfaces and applet tools are provided in the client-tier for easy access to the image archive system over the Internet. Benchmark test results show that our three-tier image archive system yields fast system response time for uploading, downloading, and querying the image database.

  13. 78 FR 63225 - Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Ear, Nose and Throat Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice...

  14. Towards THz medical imaging; reflective imaging of animal tissues.

    PubMed

    Singh, Rahul S; Taylor, Zachary D; Culjat, Martin O; Grundfest, Warren S; Brown, Elliott R

    2008-01-01

    A reflective THz imaging system has been developed, and features a photoconductive switch and zero-bias Schottky diode detector. The system was used to image deli meats and can distinguish between muscle and adipose tissue based on water content. This capability is a step towards the development of THz medical imaging systems.

  15. Development of wearable medical device for Bio-MEMS

    NASA Astrophysics Data System (ADS)

    Nakanishi, Naoyuki; Yamamoto, Hidetake; Tsuchiya, Kazuyoshi; Uetsuji, Yasutomo; Nakamachi, Eiji

    2006-01-01

    Biomedical Micro Electro Mechanical Systems (Bio-MEMS) have been applied to the development of a variety of health care related products including health Monitoring Systems (HMS) and Drug Delivery Systems (DDS). We focus on research to develop the new type compact medical device used for blood sugar control. The new type compact medical device comprises (1) a micropump system to extract blood using a pressure change occurred by electrolysis, (2) a platinum (Pt) electrode as a blood sugar sensor immobilized Glucose Oxidase (GOx) and attached to the gate electrode of Metal-Oxide-Semiconductor Field Effect Transistor (MOSFET) to detect the amount of glucose in extracted blood, and (3) a micropump system to inject insulin using a pressure change occurred by electrolysis. The device can extract blood in a few microliter through a painless microneedle with the micropump, which used the pressure change occurred by electrolysis. The liquid extraction ability of the micropump system through a microneedle, which is 3.8 mm in length and 100 μm in internal diameter, was measured. The wearable medical device with using the micropump controlled by electrolysis could extract human blood at the speed of 0.15 μl/sec. If the wearable medical device extracts human blood for 6 seconds, it is enough human blood volume to measure a glucose level, compared to the amount of commercial based glucose level monitor. The compact medical device with the air bubble that occurred by electrolysis could inject insulin at the speed of 6.15μl/sec.

  16. Dynamic DICOM configuration in a service-oriented medical device architecture.

    PubMed

    Schlamelcher, Jan; Onken, Michael; Eichelberg, Marco; Hein, Andreas

    2015-08-01

    A surgical intervention raises additional requirements to a medical device network, be it security concerns or the demand for just-in-time integration of an additional devices. The German national flagship project OR.NET aims to satisfy these requirements by defining, implementing and validating an integration solution for safe and dynamic networking. This work presents an approach to incorporate imaging related medical devices into a dynamic plug and play operating room (OR) network utilizing the existing Digital Imaging and Communications in Medicine (DICOM) protocol. The presented approach was created as part of the OR.NET project to realize the integration of DICOM devices into the developed infrastructure, both in regard to newly created DICOM devices with direct support of the OR.NET protocol and the integration of existing DICOM devices (e.g. image archives) employing a gateway. Preliminary evaluation results indicate that the approach is viable and that no critical transmission delays are introduced by the prototypical gateway implementation.

  17. Advances in scintillators for medical imaging applications

    NASA Astrophysics Data System (ADS)

    van Loef, Edgar V.; Shah, Kanai S.

    2014-09-01

    A review is presented of some recent work in the field of inorganic scintillator research for medical imaging applications, in particular scintillation detectors for Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET).

  18. Scientific evaluation and pricing of medical devices and associated procedures in France.

    PubMed

    Gilard, Martine; Debroucker, Frederique; Dubray, Claude; Allioux, Yves; Aper, Eliane; Barat-Leonhardt, Valérie; Brami, Michèle; Carbonneil, Cédric; Chartier-Kastler, Emmanuel; Coqueblin, Claire; Fare, Sandrine; Giri, Isabelle; Goehrs, Jean-Marie; Levesque, Karine; Maugendre, Philippe; Parquin, François; Sales, Jean-Patrick; Szwarcensztein, Karine

    2013-01-01

    Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented.

  19. Medical image segmentation by MDP model

    NASA Astrophysics Data System (ADS)

    Lu, Yisu; Chen, Wufan

    2011-11-01

    MDP (Dirichlet Process Mixtures) model is applied to segment medical images in this paper. Segmentation can been automatically done without initializing segmentation class numbers. The MDP model segmentation algorithm is used to segment natural images and MR (Magnetic Resonance) images in the paper. To demonstrate the accuracy of the MDP model segmentation algorithm, many compared experiments, such as EM (Expectation Maximization) image segmentation algorithm, K-means image segmentation algorithm and MRF (Markov Field) image segmentation algorithm, have been done to segment medical MR images. All the methods are also analyzed quantitatively by using DSC (Dice Similarity Coefficients). The experiments results show that DSC of MDP model segmentation algorithm of all slices exceed 90%, which show that the proposed method is robust and accurate.

  20. Image processing for medical diagnosis using CNN

    NASA Astrophysics Data System (ADS)

    Arena, Paolo; Basile, Adriano; Bucolo, Maide; Fortuna, Luigi

    2003-01-01

    Medical diagnosis is one of the most important area in which image processing procedures are usefully applied. Image processing is an important phase in order to improve the accuracy both for diagnosis procedure and for surgical operation. One of these fields is tumor/cancer detection by using Microarray analysis. The research studies in the Cancer Genetics Branch are mainly involved in a range of experiments including the identification of inherited mutations predisposing family members to malignant melanoma, prostate and breast cancer. In bio-medical field the real-time processing is very important, but often image processing is a quite time-consuming phase. Therefore techniques able to speed up the elaboration play an important rule. From this point of view, in this work a novel approach to image processing has been developed. The new idea is to use the Cellular Neural Networks to investigate on diagnostic images, like: Magnetic Resonance Imaging, Computed Tomography, and fluorescent cDNA microarray images.

  1. Risks in the application of medical devices: human factors in the medical environment.

    PubMed

    Wagner, Uwe

    2010-01-01

    The more complex a medical device is, the more difficult it is to control the hazards associated with its use. A substantial percentage of harm or injuries to patients resulting from treatment can be attributed to errors. No one knows exactly how many victims have been claimed by medical errors. Studies from the United States and other countries show that 3% to 4% of all hospital patients suffer harm or injuries. This text is intended to provide a practice-oriented approach to the discussion of targeted improvement opportunities in connection with a superficial consideration of the sociotechnical system comprising the manufacturers, the medical devices, and the users in the health facilities. Analysis of the risk reports received by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) in connection with undesirable events involving the use of medical devices. Supplementary consideration of additional data from previous human factors research in the field of medicine. The evaluation period for the primary data focuses on the years 2005 to 2008. A differentiation is made between the error causal factors, man, and device. A substantial percentage of the incidents that occurred can be attributed to human blunders. Within the scope of an evaluation of more than 16 000 risk reports in connection with medical devices, 5000 risk reports could not be directly attributed to the failure of a medical device. The lack of an error culture seems to be a considerable problem. The safe and reliable development and use of medical devices requires efficient and consistent risk management. Until now, human factors are not sufficiently considered when identifying sources of errors in sociotechnical systems. The useful data required for an extensive risk assessment are missing. An interface-overlapping method of solution is required which permits system-analytical and unbiased error handling and integrates all stakeholders.

  2. Anniversary paper: evaluation of medical imaging systems.

    PubMed

    Krupinski, Elizabeth A; Jiang, Yulei

    2008-02-01

    Medical imaging used to be primarily within the domain of radiology, but with the advent of virtual pathology slides and telemedicine, imaging technology is expanding in the healthcare enterprise. As new imaging technologies are developed, they must be evaluated to assess the impact and benefit on patient care. The authors review the hierarchical model of the efficacy of diagnostic imaging systems by Fryback and Thornbury [Med. Decis. Making 11, 88-94 (1991)] as a guiding principle for system evaluation. Evaluation of medical imaging systems encompasses everything from the hardware and software used to acquire, store, and transmit images to the presentation of images to the interpreting clinician. Evaluation of medical imaging systems can take many forms, from the purely technical (e.g., patient dose measurement) to the increasingly complex (e.g., determining whether a new imaging method saves lives and benefits society). Evaluation methodologies cover a broad range, from receiver operating characteristic (ROC) techniques that measure diagnostic accuracy to timing studies that measure image-interpretation workflow efficiency. The authors review briefly the history of the development of evaluation methodologies and review ROC methodology as well as other types of evaluation methods. They discuss unique challenges in system evaluation that face the imaging community today and opportunities for future advances.

  3. Current perspectives in medical image perception

    PubMed Central

    Krupinski, Elizabeth A.

    2013-01-01

    Medical images constitute a core portion of the information a physician utilizes to render diagnostic and treatment decisions. At a fundamental level, this diagnostic process involves two basic processes: visually inspecting the image (visual perception) and rendering an interpretation (cognition). The likelihood of error in the interpretation of medical images is, unfortunately, not negligible. Errors do occur, and patients’ lives are impacted, underscoring our need to understand how physicians interact with the information in an image during the interpretation process. With improved understanding, we can develop ways to further improve decision making and, thus, to improve patient care. The science of medical image perception is dedicated to understanding and improving the clinical interpretation process. PMID:20601701

  4. Deep Learning in Medical Image Analysis

    PubMed Central

    Shen, Dinggang; Wu, Guorong; Suk, Heung-Il

    2016-01-01

    The computer-assisted analysis for better interpreting images have been longstanding issues in the medical imaging field. On the image-understanding front, recent advances in machine learning, especially, in the way of deep learning, have made a big leap to help identify, classify, and quantify patterns in medical images. Specifically, exploiting hierarchical feature representations learned solely from data, instead of handcrafted features mostly designed based on domain-specific knowledge, lies at the core of the advances. In that way, deep learning is rapidly proving to be the state-of-the-art foundation, achieving enhanced performances in various medical applications. In this article, we introduce the fundamentals of deep learning methods; review their successes to image registration, anatomical/cell structures detection, tissue segmentation, computer-aided disease diagnosis or prognosis, and so on. We conclude by raising research issues and suggesting future directions for further improvements. PMID:28301734

  5. Portable digital device UHDTV panoramic image formation

    NASA Astrophysics Data System (ADS)

    Konstantinov, I. S.; Lazarev, S. A.; Rubcov, K. A.; Maslakov, Y. N.

    2017-02-01

    Systems of panoramic photography and video are developed, as a rule, on the basis of an array of light-sensitive sensors, with different ways of positioning in space. The authors developed a high-quality portable system panoramic photo and video using a 12 light-sensitive sensors and the formation of the video standard Ultra HD 4K. According to the simulation results, it was found that the optimal arrangement of 12 the light-sensitive sensors in conjunction with lenses is their location in the center of the dodecahedron faces. In this case, part of the image formed on each photosensitive lens sensor is unique (not repeating other sensors) as part of the panorama of a regular pentagon. This design allows you to create a panorama of 360-degrees. The developed system is a panoramic photo and video, using PLD (programmable logic devices) and includes modules removal of distortions, masking, calibration, image formation on the sphere describing the dodecahedron and obtaining equidistant projection, modules and compression encoding an image. The article presents the basic elements of the developed system of panoramic photography and video.

  6. Research imaging in an academic medical center.

    PubMed

    Armato, Samuel G; Gruszauskas, Nicholas P; Macmahon, Heber; Torno, Michael D; Li, Feng; Engelmann, Roger M; Starkey, Adam; Pudela, Caileigh L; Marino, Jonathan S; Santiago, Faustino; Chang, Paul J; Giger, Maryellen L

    2012-06-01

    Managing and supervising the complex imaging examinations performed for clinical research in an academic medical center can be a daunting task. Coordinating with both radiology and research staff to ensure that the necessary imaging is performed, analyzed, and delivered in accordance with the research protocol is nontrivial. The purpose of this communication is to report on the establishment of a new Human Imaging Research Office (HIRO) at our institution that provides a dedicated infrastructure to assist with these issues and improve collaborations between radiology and research staff. The HIRO was created with three primary responsibilities: 1) coordinate the acquisition of images for clinical research per the study protocol, 2) facilitate reliable and consistent assessment of disease response for clinical research, and 3) manage and distribute clinical research images in a compliant manner. The HIRO currently provides assistance for 191 clinical research studies from 14 sections and departments within our medical center and performs quality assessment of image-based measurements for six clinical research studies. The HIRO has fulfilled 1806 requests for medical images, delivering 81,712 imaging examinations (more than 44.1 million images) and related reports to investigators for research purposes. The ultimate goal of the HIRO is to increase the level of satisfaction and interaction among investigators, research subjects, radiologists, and other imaging professionals. Clinical research studies that use the HIRO benefit from a more efficient and accurate imaging process. The HIRO model could be adopted by other academic medical centers to support their clinical research activities; the details of implementation may differ among institutions, but the need to support imaging in clinical research through a dedicated, centralized initiative should apply to most academic medical centers. Copyright © 2012 AUR. Published by Elsevier Inc. All rights reserved.

  7. A cloud-based medical image repository

    NASA Astrophysics Data System (ADS)

    Maeder, Anthony J.; Planitz, Birgit M.; El Rifai, Diaa

    2012-02-01

    Many widely used digital medical image collections have been established but these are generally used as raw data sources without related image analysis toolsets. Providing associated functionality to allow specific types of operations to be performed on these images has proved beneficial in some cases (e.g. brain image registration and atlases). However, toolset development to provide generic image analysis functions on medical images has tended to be ad hoc, with Open Source options proliferating (e.g. ITK). Our Automated Medical Image Collection Annotation (AMICA) system is both an image repository, to which the research community can contribute image datasets, and a search/retrieval system that uses automated image annotation. AMICA was designed for the Windows Azure platform to leverage the flexibility and scalability of the cloud. It is intended that AMICA will expand beyond its initial pilot implementation (for brain CT, MR images) to accommodate a wide range of modalities and anatomical regions. This initiative aims to contribute to advances in clinical research by permitting a broader use and reuse of medical image data than is currently attainable. For example, cohort studies for cases with particular physiological or phenotypical profiles will be able to source and include enough cases to provide high statistical power, allowing more individualised risk factors to be assessed and thus allowing screening and staging processes to be optimised. Also, education, training and credentialing of clinicians in image interpretation, will be more effective because it will be possible to select instances of images with specific visual aspects, or correspond to types of cases where reading performance improvement is desirable.

  8. The dilemma over reprocessing single-use medical devices.

    PubMed

    Parsons, M S

    1998-01-01

    Making informed decisions about the reuse of single-use medical devices requires considerable analysis, study and management buy-in. This article addresses such issues as the prevalence of the practice, the changing standards and guidelines, institutional responsibilities, risk and insurance concerns and the ethical issues posed by the concept of reuse.

  9. [Applications of polylactide and its copolymers in medical device fields].

    PubMed

    Qi, Xuefei; Pang, Xiubing; Wu, Kan

    2014-07-01

    Polylactide and its copolymers are a kind of biomedical material andhave been approved by U.S. Food and Drug Administration. This paper briefly introduces its applications in surgical suture, orthopedics, plastic surgery, ophthalmology and other medical device fields, and also analyzes its development in our country.

  10. Perinatal Staff Nurse Medical Device Use and Education.

    ERIC Educational Resources Information Center

    McConnell, Edwina A.

    1998-01-01

    Survey responses from 48 perinatal nurses found that most learned about medical devices by reading manuals; 75% had received inservice training; and 95% learned from other staff. Inadequate knowledge was related to fear of causing patient harm. Initial learning method influenced what was learned, and hands-on experience was considered efficacious.…

  11. From concept to exit strategies--medical device innovation.

    PubMed

    Kermit, Eben L

    2004-01-01

    It's quite a rollercoaster ride when you are part of a medical device start-up team. There are often many partners and processes that are not often taught in school or in the training to do research . For example, how does one obtain financing, protect intellectual property, set up a business, work with contract designers and/or manufacturers? Bringing a medical device business into existence is challenging and generally, only one in 10 medical device start ups make it. This lively 2-hour session brings together panelists with many years of start-up experience to give the audience a perspective of the many facets and ways to successfully (and sometimes not so successfully) bring a product to market. This is a panel discussion on the "nuts and bolts" of medical device innovation, how to do it, what to watch out for, a sharing of experience and lessons learned. The panelists include: Amir Belson M. D.--Neoguide Systems Thomas Conn--consultant Tom Goff, Kerberos MD; Eric Goldfarb--Evalve Sorin Grunwald, Ph.D./MBA--BC Tech Nicole Walker--Onset Ventures D.J. Williams, PhD--Loughborough University.

  12. Overview of deep learning in medical imaging.

    PubMed

    Suzuki, Kenji

    2017-07-08

    The use of machine learning (ML) has been increasing rapidly in the medical imaging field, including computer-aided diagnosis (CAD), radiomics, and medical image analysis. Recently, an ML area called deep learning emerged in the computer vision field and became very popular in many fields. It started from an event in late 2012, when a deep-learning approach based on a convolutional neural network (CNN) won an overwhelming victory in the best-known worldwide computer vision competition, ImageNet Classification. Since then, researchers in virtually all fields, including medical imaging, have started actively participating in the explosively growing field of deep learning. In this paper, the area of deep learning in medical imaging is overviewed, including (1) what was changed in machine learning before and after the introduction of deep learning, (2) what is the source of the power of deep learning, (3) two major deep-learning models: a massive-training artificial neural network (MTANN) and a convolutional neural network (CNN), (4) similarities and differences between the two models, and (5) their applications to medical imaging. This review shows that ML with feature input (or feature-based ML) was dominant before the introduction of deep learning, and that the major and essential difference between ML before and after deep learning is the learning of image data directly without object segmentation or feature extraction; thus, it is the source of the power of deep learning, although the depth of the model is an important attribute. The class of ML with image input (or image-based ML) including deep learning has a long history, but recently gained popularity due to the use of the new terminology, deep learning. There are two major models in this class of ML in medical imaging, MTANN and CNN, which have similarities as well as several differences. In our experience, MTANNs were substantially more efficient in their development, had a higher performance, and required a

  13. Medical applications of microwave imaging.

    PubMed

    Wang, Zhao; Lim, Eng Gee; Tang, Yujun; Leach, Mark

    2014-01-01

    Ultrawide band (UWB) microwave imaging is a promising method for the detection of early stage breast cancer, based on the large contrast in electrical parameters between malignant tumour tissue and the surrounding normal breast-tissue. In this paper, the detection and imaging of a malignant tumour are performed through a tomographic based microwave system and signal processing. Simulations of the proposed system are performed and postimage processing is presented. Signal processing involves the extraction of tumour information from background information and then image reconstruction through the confocal method delay-and-sum algorithms. Ultimately, the revision of time-delay and the superposition of more tumour signals are applied to improve accuracy.

  14. SMPTE Test Pattern For Certification Of Medical Diagnostic Display Devices

    NASA Astrophysics Data System (ADS)

    Lisk, Kenneth G.

    1984-08-01

    Since the invention of x-rays by Wilhelm Conrad Roentgen, rapid advances have been made in the radiological detection of body abnormalities. This was very evident in the 1960's and 70's when the marriage of computers to radiology gave birth to a new generation of imaging modalities such as computerized tomography, ultrasound, digital radiographic imaging, nuclear medicine, and nuclear magnetic resonance. Many of these devices employ digital computer techniques for signal manipulation, and the resultant analog diagnostic images are displayed on television monitors for viewing and on imaging cathode-ray tubes for a photographic hard copy.

  15. 76 FR 48169 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-08

    ... Microbiology/ Medical Countermeasure Devices; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION... following public meeting: ``Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical... multiplexed microbiology/medical countermeasure (MCM) devices, their clinical application and public health...

  16. Medical Device Risk Management For Performance Assurance Optimization and Prioritization.

    PubMed

    Gaamangwe, Tidimogo; Babbar, Vishvek; Krivoy, Agustina; Moore, Michael; Kresta, Petr

    2015-01-01

    Performance assurance (PA) is an integral component of clinical engineering medical device risk management. For that reason, the clinical engineering (CE) community has made concerted efforts to define appropriate risk factors and develop quantitative risk models for efficient data processing and improved PA program operational decision making. However, a common framework that relates the various processes of a quantitative risk system does not exist. This article provides a perspective that focuses on medical device quality and risk-based elements of the PA program, which include device inclusion/exclusion, schedule optimization, and inspection prioritization. A PA risk management framework is provided, and previous quantitative models that have contributed to the advancement of PA risk management are examined. A general model for quantitative risk systems is proposed, and further perspective on possible future directions in the area of PA technology is also provided.

  17. Missing data in the regulation of medical devices.

    PubMed

    Campbell, Gregory; Pennello, Gene; Yue, Lilly

    2011-03-01

    Handling missing data is an important consideration in the analysis of data from all kinds of medical device studies. Missing data in medical device studies can arise for all the reasons one might expect in pharmaceutical clinical trials. In addition, they occur by design, in nonrandomized device studies, and in evaluations of diagnostic tests. For dichotomous endpoints, a tipping point analysis can be used to examine nonparametrically the sensitivity of conclusions to missing data. In general, sensitivity analysis is an important tool to study deviations from simple assumptions about missing data, such as the data being missing at random. Approaches to missing data in Bayesian trials are discussed, including sensitivity analysis. Many types of missing data that can occur with diagnostic test evaluations are surveyed. Careful planning and conduct are recommended to minimize missing data. Although difficult, the prespecification of all missing data analysis strategies is encouraged before any data are collected.

  18. Clinical research challenges in the era of cardiovascular medical devices

    PubMed Central

    2016-01-01

    New therapeutic alternatives, such as innovative medical devices, are frequently the only treatment options left for patients when other efficient medical modalities are lacking or insufficient. Development of novel devices, which are safe and effective, requires understanding of complex premarket and postmarket provisions, including characteristics of clinical trials. Speeding up patient access to new technologies may imply the need to make choices in terms of extent and robustness of clinical evaluation without losing the patient safety perspective. In such situations, some challenges can readily arise due to existing methodological solutions and aspects of current legislation in the field. In this context, some challenges, occurring at various stages of the device lifecycle, will be presented in order to observe the changes and hopefully to contribute to better knowledge and improvements in the area. PMID:27785138

  19. [Microbiological diagnosis of medical device-associated infections].

    PubMed

    de Cueto-López, Marina; Del Pozo-León, Jose Luis; Franco-Álvarez de Luna, Francisco; Marin-Arriaza, Mercedes

    2016-12-01

    The use of surgically implanted medical devices has increased greatly over the last few years. Despite surgical advances and improvements in the materials and design of devices, infection continues to be a major complication of their use. Device-associated infections are produced mainly during their implantation and, are caused by microorganisms that are part of the skin flora. Biofilm development on device surfaces is the most important factor to explain the pathophysiological aspects of infection. Microbiological diagnosis is difficult and can often only be achieved after removal of the device. Sonication of the removed device may be a useful tool, since this procedure dislodges and disaggregates biofilm bacteria from the device. Molecular techniques, especially PCR, applied to the tissues and material obtained after sonication have shown to have a high sensitivity and specificity for the diagnosis of cardiovascular device infections. Copyright © 2015 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  20. Multispectral imaging for medical diagnosis

    NASA Technical Reports Server (NTRS)

    Anselmo, V. J.

    1977-01-01

    Photography technique determines amount of morbidity present in tissue. Imaging apparatus incorporates numerical filtering. Overall system operates in near-real time. Information gained from this system enables physician to understand extent of injury and leads to accelerated treatment.

  1. Multispectral imaging for medical diagnosis

    NASA Technical Reports Server (NTRS)

    Anselmo, V. J.

    1977-01-01

    Photography technique determines amount of morbidity present in tissue. Imaging apparatus incorporates numerical filtering. Overall system operates in near-real time. Information gained from this system enables physician to understand extent of injury and leads to accelerated treatment.

  2. Lessons learned: mobile device encryption in the academic medical center.

    PubMed

    Kusche, Kristopher P

    2009-01-01

    The academic medical center is faced with the unique challenge of meeting the multi-faceted needs of both a modern healthcare organization and an academic institution, The need for security to protect patient information must be balanced by the academic freedoms expected in the college setting. The Albany Medical Center, consisting of the Albany Medical College and the Albany Medical Center Hospital, was challenged with implementing a solution that would preserve the availability, integrity and confidentiality of business, patient and research data stored on mobile devices. To solve this problem, Albany Medical Center implemented a mobile encryption suite across the enterprise. Such an implementation comes with complexities, from performance across multiple generations of computers and operating systems, to diversity of application use mode and end user adoption, all of which requires thoughtful policy and standards creation, understanding of regulations, and a willingness and ability to work through such diverse needs.

  3. Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

    PubMed

    Hojo, Taisuke

    2017-01-01

     Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

  4. French Sizing of Medical Devices is not Fit for Purpose

    SciTech Connect

    Kibriya, Nabil Hall, Rebecca; Powell, Steven; How, Thien; McWilliams, Richard G.

    2013-08-01

    PurposeThe purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology.MethodsThe labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.ResultsA total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm.The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.ConclusionsOur results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed.

  5. French sizing of medical devices is not fit for purpose.

    PubMed

    Kibriya, Nabil; Hall, Rebecca; Powell, Steven; How, Thien; McWilliams, Richard G

    2013-08-01

    The purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology. The labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity. A total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm. The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average. Our results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed.

  6. Acoustic Waves in Medical Imaging and Diagnostics

    PubMed Central

    Sarvazyan, Armen P.; Urban, Matthew W.; Greenleaf, James F.

    2013-01-01

    Up until about two decades ago acoustic imaging and ultrasound imaging were synonymous. The term “ultrasonography,” or its abbreviated version “sonography” meant an imaging modality based on the use of ultrasonic compressional bulk waves. Since the 1990s numerous acoustic imaging modalities started to emerge based on the use of a different mode of acoustic wave: shear waves. It was demonstrated that imaging with these waves can provide very useful and very different information about the biological tissue being examined. We will discuss physical basis for the differences between these two basic modes of acoustic waves used in medical imaging and analyze the advantages associated with shear acoustic imaging. A comprehensive analysis of the range of acoustic wavelengths, velocities, and frequencies that have been used in different imaging applications will be presented. We will discuss the potential for future shear wave imaging applications. PMID:23643056

  7. Multi-channel medical imaging system

    SciTech Connect

    Frangioni, John V.

    2016-05-03

    A medical imaging system provides simultaneous rendering of visible light and fluorescent images. The system may employ dyes in a small-molecule form that remain in a subject's blood stream for several minutes, allowing real-time imaging of the subject's circulatory system superimposed upon a conventional, visible light image of the subject. The system may provide an excitation light source to excite the fluorescent substance and a visible light source for general illumination within the same optical guide used to capture images. The system may be configured for use in open surgical procedures by providing an operating area that is closed to ambient light. The systems described herein provide two or more diagnostic imaging channels for capture of multiple, concurrent diagnostic images and may be used where a visible light image may be usefully supplemented by two or more images that are independently marked for functional interest.

  8. Acoustic waves in medical imaging and diagnostics.

    PubMed

    Sarvazyan, Armen P; Urban, Matthew W; Greenleaf, James F

    2013-07-01

    Up until about two decades ago acoustic imaging and ultrasound imaging were synonymous. The term ultrasonography, or its abbreviated version sonography, meant an imaging modality based on the use of ultrasonic compressional bulk waves. Beginning in the 1990s, there started to emerge numerous acoustic imaging modalities based on the use of a different mode of acoustic wave: shear waves. Imaging with these waves was shown to provide very useful and very different information about the biological tissue being examined. We discuss the physical basis for the differences between these two basic modes of acoustic waves used in medical imaging and analyze the advantages associated with shear acoustic imaging. A comprehensive analysis of the range of acoustic wavelengths, velocities and frequencies that have been used in different imaging applications is presented. We discuss the potential for future shear wave imaging applications. Copyright © 2013 World Federation for Ultrasound in Medicine & Biology. Published by Elsevier Inc. All rights reserved.

  9. Multi-channel medical imaging system

    SciTech Connect

    Frangioni, John V

    2013-12-31

    A medical imaging system provides simultaneous rendering of visible light and fluorescent images. The system may employ dyes in a small-molecule form that remain in the subject's blood stream for several minutes, allowing real-time imaging of the subject's circulatory system superimposed upon a conventional, visible light image of the subject. The system may provide an excitation light source to excite the fluorescent substance and a visible light source for general illumination within the same optical guide used to capture images. The system may be configured for use in open surgical procedures by providing an operating area that is closed to ambient light. The systems described herein provide two or more diagnostic imaging channels for capture of multiple, concurrent diagnostic images and may be used where a visible light image may be usefully supplemented by two or more images that are independently marked for functional interest.

  10. Tiny Devices Project Sharp, Colorful Images

    NASA Technical Reports Server (NTRS)

    2009-01-01

    Displaytech Inc., based in Longmont, Colorado and recently acquired by Micron Technology Inc. of Boise, Idaho, first received a Small Business Innovation Research contract in 1993 from Johnson Space Center to develop tiny, electronic, color displays, called microdisplays. Displaytech has since sold over 20 million microdisplays and was ranked one of the fastest growing technology companies by Deloitte and Touche in 2005. Customers currently incorporate the microdisplays in tiny pico-projectors, which weigh only a few ounces and attach to media players, cell phones, and other devices. The projectors can convert a digital image from the typical postage stamp size into a bright, clear, four-foot projection. The company believes sales of this type of pico-projector may exceed $1.1 billion within 5 years.

  11. Intuitionistic fuzzy segmentation of medical images.

    PubMed

    Chaira, Tamalika

    2010-06-01

    This paper proposes a novel and probably the first method, using Attanassov intuitionistic fuzzy set theory to segment blood vessels and also the blood cells in pathological images. This type of segmentation is very important in detecting different types of human diseases, e.g., an increase in the number of vessels may lead to cancer in prostates, mammary, etc. The medical images are not properly illuminated, and segmentation in that case becomes very difficult. A novel image segmentation approach using intuitionistic fuzzy set theory and a new membership function is proposed using restricted equivalence function from automorphisms, for finding the membership values of the pixels of the image. An intuitionistic fuzzy image is constructed using Sugeno type intuitionistic fuzzy generator. Local thresholding is applied to threshold medical images. The results showed a much better performance on poor contrast medical images, where almost all the blood vessels and blood cells are visible properly. There are several fuzzy and intuitionistic fuzzy thresholding methods, but these methods are not related to the medical images. To make a comparison with the proposed method with other thresholding methods, the method is compared with six nonfuzzy, fuzzy, and intuitionistic fuzzy methods.

  12. Automated medical image library creation for education.

    PubMed

    Smith, Mark; Feied, Craig; Gillam, Michael; Handler, Jonathan

    2006-01-01

    The authors describe a method to create a medical teaching library that is automatically maintained, contains tens of thousands of radiologic images and is built using existing, internal, hospital dictations, radiologic images, and an off-the-shelf commercial search engine product (Google Inc.).

  13. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine....515 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of...

  14. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of...

  15. Improved Interactive Medical-Imaging System

    NASA Technical Reports Server (NTRS)

    Ross, Muriel D.; Twombly, Ian A.; Senger, Steven

    2003-01-01

    An improved computational-simulation system for interactive medical imaging has been invented. The system displays high-resolution, three-dimensional-appearing images of anatomical objects based on data acquired by such techniques as computed tomography (CT) and magnetic-resonance imaging (MRI). The system enables users to manipulate the data to obtain a variety of views for example, to display cross sections in specified planes or to rotate images about specified axes. Relative to prior such systems, this system offers enhanced capabilities for synthesizing images of surgical cuts and for collaboration by users at multiple, remote computing sites.

  16. Sharing medical images: a proposal of a reference image database

    NASA Astrophysics Data System (ADS)

    dos Santos, Marcelo; Furuie, Sérgio S.

    2006-03-01

    Due to increasing number of digital images used in medical diagnosis, the image processing and analysis are becoming essential for many tasks in medicine. One of the obstacles within the field of medical image processing is the lack of reference image datasets freely available for groups and/or individual users, in order to evaluate their new methods and applications. In order to improve this situation, this work presents the development of a framework to make available a free, online, multipurpose and multimodality medical image database for software and algorithm evaluation. The project is implemented as a distributed architecture for medical image database including a publishing workflow, authoring tools, and role-based access control. Our effort aims to offer a testbed and a set of resources including software, links to scientific papers, gold standards, reference and post-processed images, enabling the medical image processing community (scientists, physicians, students and industrials) to be more aware of evaluation issues. The proposed approach has been used as an electronic teaching system in Radiology as well.

  17. Feasibility of energy harvesting techniques for wearable medical devices.

    PubMed

    Voss, Thaddaeus J; Subbian, Vignesh; Beyette, Fred R

    2014-01-01

    Wearable devices are arguably one of the most rapidly growing technologies in the computing and health care industry. These systems provide improved means of monitoring health status of humans in real-time. In order to cope with continuous sensing and transmission of biological and health status data, it is desirable to move towards energy autonomous systems that can charge batteries using passive, ambient energy. This not only ensures uninterrupted data capturing, but could also eliminate the need to frequently remove, replace, and recharge batteries. To this end, energy harvesting is a promising area that can lead to extremely power-efficient portable medical devices. This paper presents an experimental prototype to study the feasibility of harvesting two energy sources, solar and thermoelectric energy, in the context of wearable devices. Preliminary results show that such devices can be powered by transducing ambient energy that constantly surrounds us.

  18. Tracking and surveillance of patients with medical devices and implants.

    PubMed

    Morgan, R W

    1993-01-01

    The United States Congress and FDA recently proposed modifications to the regulation for the tracking of certain medical devices and implants that will place significant demands on the manufacturers and importers of those products. The regulation, which comes into effect in August this year, will require the industry to carry out not only tracking of those devices or implants to the end user, but also continued observation of the device user or implant recipient throughout the life of the patient or the device. In this article, the author outlines FDA requirements and advises how best to meet those demands. The important elements for setting up a patient-tracking programme are discussed; these include the use of a Patient Registry as a basis for tracking and the importance of confidentiality throughout the tracking process.

  19. Image readout device with electronically variable spatial resolution

    NASA Astrophysics Data System (ADS)

    Benz, H. A.

    1981-07-01

    An invention relating to the use of a standing acoustic wave charge storage device as an image readout device is described. A frequency f sub 1 was applied to the storage transfer device to create a traveling electric field in the device in one direction along a straight line. A second frequency f sub 2 was applied to the charge transfer device to create a traveling electric field opposite to the first traveling electric field. A standing wave was created. When an image was focused on the charge transfer device, light was stored in the wells of the standing wave. When the frequency f sub 2 is removed from the device, the standing wave tends to break up and the charges stored move to an electrode connected to an output terminal and to a utilization device where the received charges represent the image on the surface of the charge transfer device along a projection of said straight line.

  20. Medical imaging techniques: implications for nursing care.

    PubMed

    Malcolm, Alison

    The four basic techniques of medical imaging are X-ray, ultrasound, magnetic resonance and radionuclide. This article describes imaging techniques that display anatomical structure and those that are better at showing the physiological function of organs and tissues. Safety and preparation relating to nursing practice are discussed. Understanding the purpose and limitations of the different imaging techniques is important for providing best patient care.

  1. Wearable Devices in Medical Internet of Things: Scientific Research and Commercially Available Devices

    PubMed Central

    Thurow, Kerstin; Stoll, Regina

    2017-01-01

    Objectives Wearable devices are currently at the heart of just about every discussion related to the Internet of Things. The requirement for self-health monitoring and preventive medicine is increasing due to the projected dramatic increase in the number of elderly people until 2020. Developed technologies are truly able to reduce the overall costs for prevention and monitoring. This is possible by constantly monitoring health indicators in various areas, and in particular, wearable devices are considered to carry this task out. These wearable devices and mobile apps now have been integrated with telemedicine and telehealth efficiently, to structure the medical Internet of Things. This paper reviews wearable health care devices both in scientific papers and commercial efforts. Methods MIoT is demonstrated through a defined architecture design, including hardware and software dealing with wearable devices, sensors, smart phones, medical application, and medical station analyzers for further diagnosis and data storage. Results Wearables, with the help of improved technology have been developed greatly and are considered reliable tools for long-term health monitoring systems. These are applied in the observation of a large variety of health monitoring indicators in the environment, vital signs, and fitness. Conclusions Wearable devices are now used for a wide range of healthcare observation. One of the most important elements essential in data collection is the sensor. During recent years with improvement in semiconductor technology, sensors have made investigation of a full range of parameters closer to realization. PMID:28261526

  2. Wearable Devices in Medical Internet of Things: Scientific Research and Commercially Available Devices.

    PubMed

    Haghi, Mostafa; Thurow, Kerstin; Stoll, Regina

    2017-01-01

    Wearable devices are currently at the heart of just about every discussion related to the Internet of Things. The requirement for self-health monitoring and preventive medicine is increasing due to the projected dramatic increase in the number of elderly people until 2020. Developed technologies are truly able to reduce the overall costs for prevention and monitoring. This is possible by constantly monitoring health indicators in various areas, and in particular, wearable devices are considered to carry this task out. These wearable devices and mobile apps now have been integrated with telemedicine and telehealth efficiently, to structure the medical Internet of Things. This paper reviews wearable health care devices both in scientific papers and commercial efforts. MIoT is demonstrated through a defined architecture design, including hardware and software dealing with wearable devices, sensors, smart phones, medical application, and medical station analyzers for further diagnosis and data storage. Wearables, with the help of improved technology have been developed greatly and are considered reliable tools for long-term health monitoring systems. These are applied in the observation of a large variety of health monitoring indicators in the environment, vital signs, and fitness. Wearable devices are now used for a wide range of healthcare observation. One of the most important elements essential in data collection is the sensor. During recent years with improvement in semiconductor technology, sensors have made investigation of a full range of parameters closer to realization.

  3. Medical Applications of Microwave Imaging

    PubMed Central

    Wang, Zhao; Lim, Eng Gee; Tang, Yujun

    2014-01-01

    Ultrawide band (UWB) microwave imaging is a promising method for the detection of early stage breast cancer, based on the large contrast in electrical parameters between malignant tumour tissue and the surrounding normal breast-tissue. In this paper, the detection and imaging of a malignant tumour are performed through a tomographic based microwave system and signal processing. Simulations of the proposed system are performed and postimage processing is presented. Signal processing involves the extraction of tumour information from background information and then image reconstruction through the confocal method delay-and-sum algorithms. Ultimately, the revision of time-delay and the superposition of more tumour signals are applied to improve accuracy. PMID:25379515

  4. A patient-centric distribution architecture for medical image sharing.

    PubMed

    Constantinescu, Liviu; Kim, Jinman; Kumar, Ashnil; Haraguchi, Daiki; Wen, Lingfeng; Feng, Dagan

    2013-01-01

    Over the past decade, rapid development of imaging technologies has resulted in the introduction of improved imaging devices, such as multi-modality scanners that produce combined positron emission tomography-computed tomography (PET-CT) images. The adoption of picture archiving and communication systems (PACS) in hospitals have dramatically improved the ability to digitally share medical image studies via portable storage, mobile devices and the Internet. This has in turn led to increased productivity, greater flexibility, and improved communication between hospital staff, referring physicians, and outpatients. However, many of these sharing and viewing capabilities are limited to proprietary vendor-specific applications. Furthermore, there are still interoperability and deployment issues which reduce the rate of adoption of such technologies, thus leaving many stakeholders, particularly outpatients and referring physicians, with access to only traditional still images with no ability to view or interpret the data in full. In this paper, we present a distribution architecture for medical image display across numerous devices and media, which uses a preprocessor and an in-built networking framework to improve compatibility and promote greater accessibility of medical data. Our INVOLVE2 system consists of three main software modules: 1) a preprocessor, which collates and converts imaging studies into a compressed and distributable format; 2) a PACS-compatible workflow for self-managing distribution of medical data, e.g. via CD USB, network etc; 3) support for potential mobile and web-based data access. The focus of this study was on cultivating patient-centric care, by allowing outpatient users to comfortably access and interpret their own data. As such, the image viewing software included on our cross-platform CDs was designed with a simple and intuitive user-interface (UI) for use by outpatients and referring physicians. Furthermore, digital image access via

  5. Deep Learning in Medical Image Analysis.

    PubMed

    Shen, Dinggang; Wu, Guorong; Suk, Heung-Il

    2017-03-09

    This review covers computer-assisted analysis of images in the field of medical imaging. Recent advances in machine learning, especially with regard to deep learning, are helping to identify, classify, and quantify patterns in medical images. At the core of these advances is the ability to exploit hierarchical feature representations learned solely from data, instead of features designed by hand according to domain-specific knowledge. Deep learning is rapidly becoming the state of the art, leading to enhanced performance in various medical applications. We introduce the fundamentals of deep learning methods and review their successes in image registration, detection of anatomical and cellular structures, tissue segmentation, computer-aided disease diagnosis and prognosis, and so on. We conclude by discussing research issues and suggesting future directions for further improvement. Expected final online publication date for the Annual Review of Biomedical Engineering Volume 19 is June 4, 2017. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

  6. Monte Carlo simulations of medical imaging modalities

    SciTech Connect

    Estes, G.P.

    1998-09-01

    Because continuous-energy Monte Carlo radiation transport calculations can be nearly exact simulations of physical reality (within data limitations, geometric approximations, transport algorithms, etc.), it follows that one should be able to closely approximate the results of many experiments from first-principles computations. This line of reasoning has led to various MCNP studies that involve simulations of medical imaging modalities and other visualization methods such as radiography, Anger camera, computerized tomography (CT) scans, and SABRINA particle track visualization. It is the intent of this paper to summarize some of these imaging simulations in the hope of stimulating further work, especially as computer power increases. Improved interpretation and prediction of medical images should ultimately lead to enhanced medical treatments. It is also reasonable to assume that such computations could be used to design new or more effective imaging instruments.

  7. Medical image segmentation using genetic algorithms.

    PubMed

    Maulik, Ujjwal

    2009-03-01

    Genetic algorithms (GAs) have been found to be effective in the domain of medical image segmentation, since the problem can often be mapped to one of search in a complex and multimodal landscape. The challenges in medical image segmentation arise due to poor image contrast and artifacts that result in missing or diffuse organ/tissue boundaries. The resulting search space is therefore often noisy with a multitude of local optima. Not only does the genetic algorithmic framework prove to be effective in coming out of local optima, it also brings considerable flexibility into the segmentation procedure. In this paper, an attempt has been made to review the major applications of GAs to the domain of medical image segmentation.

  8. Radiology and Enterprise Medical Imaging Extensions (REMIX).

    PubMed

    Erdal, Barbaros S; Prevedello, Luciano M; Qian, Songyue; Demirer, Mutlu; Little, Kevin; Ryu, John; O'Donnell, Thomas; White, Richard D

    2017-08-24

    Radiology and Enterprise Medical Imaging Extensions (REMIX) is a platform originally designed to both support the medical imaging-driven clinical and clinical research operational needs of Department of Radiology of The Ohio State University Wexner Medical Center. REMIX accommodates the storage and handling of "big imaging data," as needed for large multi-disciplinary cancer-focused programs. The evolving REMIX platform contains an array of integrated tools/software packages for the following: (1) server and storage management; (2) image reconstruction; (3) digital pathology; (4) de-identification; (5) business intelligence; (6) texture analysis; and (7) artificial intelligence. These capabilities, along with documentation and guidance, explaining how to interact with a commercial system (e.g., PACS, EHR, commercial database) that currently exists in clinical environments, are to be made freely available.

  9. Photoacoustic imaging: opening new frontiers in medical imaging.

    PubMed

    Valluru, Keerthi S; Chinni, Bhargava K; Rao, Navalgund A

    2011-01-01

    In today's world, technology is advancing at an exponential rate and medical imaging is no exception. During the last hundred years, the field of medical imaging has seen a tremendous technological growth with the invention of imaging modalities including but not limited to X-ray, ultrasound, computed tomography, magnetic resonance imaging, positron emission tomography, and single-photon emission computed tomography. These tools have led to better diagnosis and improved patient care. However, each of these modalities has its advantages as well as disadvantages and none of them can reveal all the information a physician would like to have. In the last decade, a new diagnostic technology called photoacoustic imaging has evolved which is moving rapidly from the research phase to the clinical trial phase. This article outlines the basics of photoacoustic imaging and describes our hands-on experience in developing a comprehensive photoacoustic imaging system to detect tissue abnormalities.

  10. A Review of Numerical Simulation and Analytical Modeling for Medical Devices Safety in MRI.

    PubMed

    Kabil, J; Belguerras, L; Trattnig, S; Pasquier, C; Felblinger, J; Missoffe, A

    2016-11-10

    To review past and present challenges and ongoing trends in numerical simulation for MRI (Magnetic Resonance Imaging) safety evaluation of medical devices. A wide literature review on numerical and analytical simulation on simple or complex medical devices in MRI electromagnetic fields shows the evolutions through time and a growing concern for MRI safety over the years. Major issues and achievements are described, as well as current trends and perspectives in this research field. Numerical simulation of medical devices is constantly evolving, supported by calculation methods now well-established. Implants with simple geometry can often be simulated in a computational human model, but one issue remaining today is the experimental validation of these human models. A great concern is to assess RF heating on implants too complex to be traditionally simulated, like pacemaker leads. Thus, ongoing researches focus on alternative hybrids methods, both numerical and experimental, with for example a transfer function method. For the static field and gradient fields, analytical models can be used for dimensioning simple implants shapes, but limited for complex geometries that cannot be studied with simplifying assumptions. Numerical simulation is an essential tool for MRI safety testing of medical devices. The main issues remain the accuracy of simulations compared to real life and the studies of complex devices; but as the research field is constantly evolving, some promising ideas are now under investigation to take up the challenges.

  11. Quantitative imaging features: extension of the oncology medical image database

    NASA Astrophysics Data System (ADS)

    Patel, M. N.; Looney, P. T.; Young, K. C.; Halling-Brown, M. D.

    2015-03-01

    Radiological imaging is fundamental within the healthcare industry and has become routinely adopted for diagnosis, disease monitoring and treatment planning. With the advent of digital imaging modalities and the rapid growth in both diagnostic and therapeutic imaging, the ability to be able to harness this large influx of data is of paramount importance. The Oncology Medical Image Database (OMI-DB) was created to provide a centralized, fully annotated dataset for research. The database contains both processed and unprocessed images, associated data, and annotations and where applicable expert determined ground truths describing features of interest. Medical imaging provides the ability to detect and localize many changes that are important to determine whether a disease is present or a therapy is effective by depicting alterations in anatomic, physiologic, biochemical or molecular processes. Quantitative imaging features are sensitive, specific, accurate and reproducible imaging measures of these changes. Here, we describe an extension to the OMI-DB whereby a range of imaging features and descriptors are pre-calculated using a high throughput approach. The ability to calculate multiple imaging features and data from the acquired images would be valuable and facilitate further research applications investigating detection, prognosis, and classification. The resultant data store contains more than 10 million quantitative features as well as features derived from CAD predictions. Theses data can be used to build predictive models to aid image classification, treatment response assessment as well as to identify prognostic imaging biomarkers.

  12. Imaging requirements for medical applications of additive manufacturing.

    PubMed

    Huotilainen, Eero; Paloheimo, Markku; Salmi, Mika; Paloheimo, Kaija-Stiina; Björkstrand, Roy; Tuomi, Jukka; Markkola, Antti; Mäkitie, Antti

    2014-02-01

    Additive manufacturing (AM), formerly known as rapid prototyping, is steadily shifting its focus from industrial prototyping to medical applications as AM processes, bioadaptive materials, and medical imaging technologies develop, and the benefits of the techniques gain wider knowledge among clinicians. This article gives an overview of the main requirements for medical imaging affected by needs of AM, as well as provides a brief literature review from existing clinical cases concentrating especially on the kind of radiology they required. As an example application, a pair of CT images of the facial skull base was turned into 3D models in order to illustrate the significance of suitable imaging parameters. Additionally, the model was printed into a preoperative medical model with a popular AM device. Successful clinical cases of AM are recognized to rely heavily on efficient collaboration between various disciplines - notably operating surgeons, radiologists, and engineers. The single main requirement separating tangible model creation from traditional imaging objectives such as diagnostics and preoperative planning is the increased need for anatomical accuracy in all three spatial dimensions, but depending on the application, other specific requirements may be present as well. This article essentially intends to narrow the potential communication gap between radiologists and engineers who work with projects involving AM by showcasing the overlap between the two disciplines.

  13. Career development of biomedical engineers in medical device industry.

    PubMed

    Ni, Quan; Pu, Yachuan

    2009-01-01

    With concerns of the current health care system, biomedical engineers have expertise, opportunity and responsibility in developing innovations that may improve cost, coverage and quality of health care delivery. This paper reviews the product development process in the medical device industry, and the associated training and experience required for biomedical engineers involved at each stage of the process. This paper also provides personal perspectives of some of the differences between established device companies and start-ups in the product development process and career paths for biomedical engineers.

  14. Micro Computer Tomography for medical device and pharmaceutical packaging analysis.

    PubMed

    Hindelang, Florine; Zurbach, Raphael; Roggo, Yves

    2015-04-10

    Biomedical device and medicine product manufacturing are long processes facing global competition. As technology evolves with time, the level of quality, safety and reliability increases simultaneously. Micro Computer Tomography (Micro CT) is a tool allowing a deep investigation of products: it can contribute to quality improvement. This article presents the numerous applications of Micro CT for medical device and pharmaceutical packaging analysis. The samples investigated confirmed CT suitability for verification of integrity, measurements and defect detections in a non-destructive manner. Copyright © 2015 Elsevier B.V. All rights reserved.

  15. Tunable Ultrasonic Energy Harvesting for Implantable Biosensors and Medical Devices

    NASA Astrophysics Data System (ADS)

    Pellegrino, M.; Eovino, B. E.; Beker, L.; Bourouina, T.; Lin, L.

    2016-11-01

    This work reports a tunable ultrasonic energy harvesting (UEH) device capable of high power output and/or large bandwidth based on concentric piezoelectric ring-shaped structures. Two different designs are presented: (1) the single ring-shaped UEH (r-UEH), and (2) concentric r-UEHs. Concentric r-UEHs can save space and therefore can provide benefits in powering low-power implantable biosensors and medical devices. This paper presents results of simulation studies and initial experiments of a single r-UEH.

  16. Perspectives of medical X-ray imaging

    NASA Astrophysics Data System (ADS)

    Freudenberger, J.; Hell, E.; Knüpfer, W.

    2001-06-01

    While X-ray image intensifiers (XII), storage phosphor screens and film-screen systems are still the work horses of medical imaging, large flat panel solid state detectors using either scintillators and amorphous silicon photo diode arrays (FD-Si), or direct X-ray conversion in amorphous selenium are reaching maturity. The main advantage with respect to image quality and low patient dose of the XII and FD-Si systems is caused by the rise of the Detector Quantum Efficiency originating from the application of thick needle-structured phosphor X-ray absorbers. With the detectors getting closer to an optimal state, further progress in medical X-ray imaging requires an improvement of the usable source characteristics. The development of clinical monochromatic X-ray sources of high power would not only allow an improved contrast-to-dose ratio by allowing smaller average photon energies in applications but would also lead to new imaging techniques.

  17. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; prominence of required label... SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices... information, resulting from the use of label space for any word, statement, design, or device which is...

  18. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device... reactivity of the human blood or blood component in the medical device presents no significant health...

  19. 21 CFR 801.150 - Medical devices; processing, labeling, or repacking.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; processing, labeling, or... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Other Exemptions § 801.150 Medical devices... shipment or other delivery of a device which is, in accordance with the practice of the trade, to...

  20. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; prominence of required label... SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices... information, resulting from the use of label space for any word, statement, design, or device which is...