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. PMID:25467905

  2. 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... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  3. 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...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  4. 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... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  5. 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...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  6. 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...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  7. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  8. 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... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  9. 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... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  10. 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... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  11. 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...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  12. 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... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  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... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  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... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  15. 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... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  16. 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... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  17. 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

  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. Medical Device Safety

    MedlinePlus

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices Medical Device Safety Medical Device Safety Share Tweet Linkedin Pin it More sharing ...

  20. Medical devices; gastroenterology-urology devices; classification of the ingestible telemetric gastrointestinal capsule imaging system. Final rule.

    PubMed

    2002-01-24

    The Food and Drug Administration (FDA) is classifying the ingestible telemetric gastrointestinal capsule imaging system device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:11820252

  1. 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. PMID:17476069

  2. 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.

  3. 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. PMID:22741084

  4. 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 ...

  5. Medical Device Safety

    MedlinePlus

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

  6. 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.

  7. 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.

  8. Medical device error.

    PubMed

    Goodman, Gerald R

    2002-12-01

    This article discusses principal concepts for the analysis, classification, and reporting of problems involving medical device technology. We define a medical device in regulatory terminology and define and discuss concepts and terminology used to distinguish the causes and sources of medical device problems. Database classification systems for medical device failure tracking are presented, as are sources of information on medical device failures. The importance of near-accident reporting is discussed to alert users that reported medical device errors are typically limited to those that have caused an injury or death. This can represent only a fraction of the true number of device problems. This article concludes with a summary of the most frequently reported medical device failures by technology type, clinical application, and clinical setting. PMID:12400632

  9. 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)

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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...

  11. 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. PMID:27040333

  12. [Implantable medical devices].

    PubMed

    Crickx, B; Arrault, X

    2008-01-01

    Medical devices have been individualized to include a category of implantable medical devices, "designed to be totally implanted in the human body or to replace an epithelial surface or a surface of the eye, through surgery, and remain in place after the intervention" (directive 93/42/CEE and decree of 20 April 206). Each implantable medical device has a common name and a commercial name for precise identification of the model (type/references). The users' service and the implanting physician should be clearly identified. There are a number of rules concerning health traceability to rapidly identify patients exposed to risks in which the implantable medical devices of a particular batch or series were used and to monitor the consequences. The traceability data should be preserved 10 years and the patient's medical file for 20 years. PMID:18442666

  13. Medical imaging

    SciTech Connect

    Chapman, D.

    1996-09-01

    There are a number of medically related imaging programs at synchrotron facilities around the world. The most advanced of these are the dual energy transvenous coronary angiography imaging programs, which have progressed to human imaging for some years. The NSLS facility will be discussed and patient images from recent sessions from the NSLS and HASYLAB will be presented. The effort at the Photon Factory and Accumulator Ring will also be briefly covered, as well as future plans for the new facilities. Emphasis will be on the new aspects of these imaging programs; this includes imaging with a peripheral venous injection of the iodine contrast agent, imaging at three photon energies, and the potential of a hospital-based compact source. Other medical programs to be discussed, are the multiple energy computed tomography (MECT) project at the NSLS and plans for a MECT program at the ESRF. Recently, experiments performed at the NSLS to image mammography phantoms using monochromatic beam have produced very promising results. This program will be discussed as well as some new results from imaging a phantom using a thin Laue crystal analyzer after the object to eliminate scatter onto the detector. {copyright} {ital 1996 American Institute of Physics.}

  14. [Quality improvement of the medical images in digital and optoelectronic devices].

    PubMed

    Shlychkoiv, V I; Shchukin, I V

    1981-01-01

    The realization of image processing algorithms in a hybrid optoelectronic device is discussed. The linear part of the algorithm is carried out in the optical block, and the nonlinear part of the algorithm in the electronic processing block of the device. These studies indicate the expediency of using the optical methods for processing the images of medico-biological objects to facilitate their visual analysis. PMID:7321818

  15. 75 FR 8375 - Device Improvements to Reduce Unnecessary Radiation Exposure From Medical Imaging; Public Meeting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ..., and metrics of body dose and peak skin dose are displayed to the operator(s) of the equipment and... devices, demonstrating dose reduction and image quality claims? If so, why, and what data should be..., operating principles for the technology, general information about optimizing patient dose and image...

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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...

  17. 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. PMID:19058651

  18. Image quality degradation by light-scattering processes in high-performance display devices for medical imaging

    NASA Astrophysics Data System (ADS)

    Badano, Aldo

    1999-11-01

    This thesis addresses the characterization of light scattering processes that degrade image quality in high performance electronic display devices for digital radiography. Using novel experimental and computational tools, we study the lateral diffusion of light in emissive display devices that causes extensive veiling glare and significant reduction of the physical contrast. In addition, we examine the deleterious effects of ambient light reflections that affect the contrast of low luminance regions, and superimpose unwanted structured signal. The analysis begins by introducing the performance limitations of the human visual system to define high fidelity requirements. It is noted that current devices severely suffer from image quality degradation due to optical transport processes. To model the veiling glare and reflectance characteristics of display devices, we introduce a Monte Carlo light transport simulation code, DETECT-II, that tracks individual photons through multiple scattering events. The simulation accounts for the photon polarization state at each scattering event, and provides descriptions for rough surfaces and thin film coatings. A new experimental method to measure veiling glare is described next, based on a conic collimated probe that minimizes contamination from bright areas. The measured veiling glare ratio is taken to be the luminance in the surrounding bright field divided by the luminance in the dark circle. We show that veiling glare ratios in the order of a few hundreds can be measured with an uncertainty of a few percent. The veiling glare response function is obtained by measuring the small spot contrast ratio of test patterns having varying dark spot radius. Using DETECT-II, we then estimate the ring response functions for a high performance medical imaging monitor of current design, and compare the predictions of the model with the experimentally measured response function. The data presented in this thesis demonstrate that although

  19. 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

  20. 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...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2030 Medical image digitizer. (a) Identification. A medical image digitizer is a device intended to convert an analog medical image into a...

  1. 21 CFR 892.2030 - Medical image digitizer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image digitizer. 892.2030 Section 892.2030...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2030 Medical image digitizer. (a) Identification. A medical image digitizer is a device intended to convert an analog medical image into a...

  2. 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...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2030 Medical image digitizer. (a) Identification. A medical image digitizer is a device intended to convert an analog medical image into a...

  3. 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...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2030 Medical image digitizer. (a) Identification. A medical image digitizer is a device intended to convert an analog medical image into a...

  4. 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...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2030 Medical image digitizer. (a) Identification. A medical image digitizer is a device intended to convert an analog medical image into a...

  5. 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…

  6. Barriers to medical device innovation

    PubMed Central

    Bergsland, Jacob; Elle, Ole Jakob; Fosse, Erik

    2014-01-01

    The US Food and Drug Administration (FDA) has defined a medical device as a health care product that does not achieve it’s purpose by chemical action or by being metabolized. This means that a vast number of products are considered medical devices. Such devices play an essential role in the practice of medicine. The FDA classifies medical devices in three classes, depending on the risk of the device. Since Class I and II devices have relatively simple requirements for getting to the market, this review will focus on “implantable devices”, which, in general, belong to Class III. The European Union and Canada use a slightly different classification system. While early generations of medical devices were introduced without much testing, either technical or clinical, the process of introducing a Class III medical device from concept to clinical practice has become strongly regulated and requires extensive technological and clinical testing. The modern era of implantable medical devices may be considered to have started in the 1920s with development of artificial hips. The implantable pacemaker was another milestone and pacemakers and cardioverters/defibrillators have since saved millions of lives and created commercial giants in the medical device industry. This review will include some examples of cardiovascular devices. Similar considerations apply to the total implantable device market, although clinical and technological applications obviously vary considerably. PMID:24966699

  7. 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.

  8. Medical Images Remote Consultation

    NASA Astrophysics Data System (ADS)

    Ferraris, Maurizio; Frixione, Paolo; Squarcia, Sandro

    Teleconsultation of digital images among different medical centers is now a reality. The problem to be solved is how to interconnect all the clinical diagnostic devices in a hospital in order to allow physicians and health physicists, working in different places, to discuss on interesting clinical cases visualizing the same diagnostic images at the same time. Applying World Wide Web technologies, the proposed system can be easily used by people with no specific computer knowledge providing a verbose help to guide the user through the right steps of execution. Diagnostic images are retrieved from a relational database or from a standard DICOM-PACS through the DICOM-WWW gateway allowing connection of the usual Web browsers to DICOM applications via the HTTP protocol. The system, which is proposed for radiotherapy implementation, where radiographies play a fundamental role, can be easily converted to different field of medical applications where a remote access to secure data are compulsory.

  9. Implantable medical devices MRI safe.

    PubMed

    Dal Molin, Renzo; Hecker, Bertrand

    2013-01-01

    Pacemakers, ICDs, neurostimulators like deep brain stimulator electrodes, spiral cord stimulators, insulin pumps, cochlear implants, retinal implants, hearing aids, electro cardio gram (ECG) leads, or devices in interventional MRI such as vascular guide wires or catheters are affected by MRI magnetic and electromagnetic fields. Design of MRI Safe medical devices requires computer modeling, bench testing, phantom testing, and animal studies. Implanted medical devices can be MRI unsafe, MRI conditional or MRI safe (see glossary). In the following paragraphs we will investigate how to design implanted medical devices MRI safe. PMID:23739365

  10. Device for wavelength-selective imaging

    DOEpatents

    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.

  11. 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

  12. 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.

  13. [Medical image compression: a review].

    PubMed

    Noreña, Tatiana; Romero, Eduardo

    2013-01-01

    Modern medicine is an increasingly complex activity , based on the evidence ; it consists of information from multiple sources : medical record text , sound recordings , images and videos generated by a large number of devices . Medical imaging is one of the most important sources of information since they offer comprehensive support of medical procedures for diagnosis and follow-up . However , the amount of information generated by image capturing gadgets quickly exceeds storage availability in radiology services , generating additional costs in devices with greater storage capacity . Besides , the current trend of developing applications in cloud computing has limitations, even though virtual storage is available from anywhere, connections are made through internet . In these scenarios the optimal use of information necessarily requires powerful compression algorithms adapted to medical activity needs . In this paper we present a review of compression techniques used for image storage , and a critical analysis of them from the point of view of their use in clinical settings. PMID:23715317

  14. 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.

  15. Medical devices; device tracking. Final rule.

    PubMed

    2002-02-01

    The Food and Drug Administration (FDA) is amending the medical device tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA), and to simplify certain requirements. PMID:11838471

  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. PMID:25735659

  17. NASA Technology Finds Uses in Medical Imaging

    NASA Video Gallery

    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...

  18. 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. PMID:18997210

  19. Investing in medical device companies.

    PubMed

    Benson, B; Mutsch, E

    1993-11-01

    For companies seeking investors, money is available, but it is not as easy to obtain as it has been in recent years. Although the medical device industry remains an attractive proposition, several factors have contributed to the downturn in public-offering investment. This article outlines these factors and discusses the types of medical technologies that are likely to attract investment in the immediate future. PMID:10146504

  20. Medical image file formats.

    PubMed

    Larobina, Michele; Murino, Loredana

    2014-04-01

    Image file format is often a confusing aspect for someone wishing to process medical images. This article presents a demystifying overview of the major file formats currently used in medical imaging: Analyze, Neuroimaging Informatics Technology Initiative (Nifti), Minc, and Digital Imaging and Communications in Medicine (Dicom). Concepts common to all file formats, such as pixel depth, photometric interpretation, metadata, and pixel data, are first presented. Then, the characteristics and strengths of the various formats are discussed. The review concludes with some predictive considerations about the future trends in medical image file formats. PMID:24338090

  1. [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. PMID:26255429

  2. [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. PMID:26665948

  3. Medical ultrasound imaging.

    PubMed

    Jensen, Jørgen Arendt

    2007-01-01

    The paper gives an introduction to current medical ultrasound imaging systems. The basics of anatomic and blood flow imaging are described. The properties of medical ultrasound and its focusing are described, and the various methods for two- and three-dimensional imaging of the human anatomy are shown. Systems using both linear and non-linear propagation of ultrasound are described. The blood velocity can also be non-invasively visualized using ultrasound and the basic signal processing for doing this is introduced. Examples for spectral velocity estimation, color flow imaging and the new vector velocity images are presented. PMID:17092547

  4. 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.

  5. Images, signals and devices

    SciTech Connect

    McDonald, C.J.

    1987-01-01

    This volume highlights medical imaging and monitoring and covers topics such as interactive video, diagnostic digital angiography, computerized management of intensive care patients, ambulatory ECG monitoring and magnetic resonance. Contents include: general guidelines; reveiws/surveys; office practice management guidelines; and clinical computing.

  6. 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.

  7. 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...

  8. 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.

  9. 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.

  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. PMID:11824451

  11. 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.

  12. Learning from adverse incidents involving medical devices.

    PubMed

    Amoore, John; Ingram, Paula

    While an adverse event involving a medical device is often ascribed to either user error or device failure, the causes are typically multifactorial. A number of incidents involving medical devices are explored using this approach to investigate the various causes of the incident and the protective barriers that minimised or prevented adverse consequences. User factors, including mistakes, omissions and lack of training, conspired with background factors--device controls and device design, storage conditions, hidden device damage and physical layout of equipment when in use--to cause the adverse events. Protective barriers that prevented or minimised the consequences included staff vigilance, operating procedures and alarms. PMID:12715578

  13. 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.

  14. 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..., 2012 (77 FR 72924). The final regulations 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...

  15. 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.

  16. Wavelets in medical imaging

    NASA Astrophysics Data System (ADS)

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

  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. PMID:25330611

  18. 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... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic...

  19. 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... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic...

  20. 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... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic...

  1. 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.

  2. SAW-Modulated Image Device

    NASA Technical Reports Server (NTRS)

    Benz, H. F.

    1985-01-01

    Imaging device uses surface-acoustic-wave (SAW) charge transfer for image readout. Spatial resolution of image changed electronically by changing frequency of applied signal. Surface acoustic waves create traveling longitudinal electric fields. These fields create potential wells that carry along stored charges. Charges injected into wells by photoelectric conversion when light strikes device.

  3. [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. PMID:27333770

  4. 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.

  5. 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. PMID:21306047

  6. 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.

  7. 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. PMID:23822402

  8. 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.

  9. 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 ...

  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...

  11. [Remote monitoring of active implantable medical device].

    PubMed

    Zhang, Yujing

    2013-09-01

    Active implantable medical device develops rapidly in recent years. The clinical demands and current application are introduced, the technical trends are discussed, and the safety risks are analyzed in this paper. PMID:24409793

  12. Medical devices for the anesthetist: current perspectives.

    PubMed

    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

  13. 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

  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. PMID:18003568

  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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration International Medical Device Regulators Forum; Medical... Medical Device Regulators Forum (IMDRF) was conceived in 2011 as a forum to discuss future directions...

  16. 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.

  17. 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.

  18. 78 FR 18233 - Medical Devices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    .../ MedicalDevices/ pma/. DeviceRegulationa ndGuidance/ HowtoMarketYourDe vice/ PremarketSubmissi ons/ PremarketApproval PMA/default.htm. 822.7 http://www.fda.gov/ http://www.fda.gov/ cdrh/ombudsman/...

  19. Medical alert bracelet (image)

    MedlinePlus

    People with diabetes should always wear a medical alert bracelet or necklace that emergency medical workers will be able to find. Medical identification products can help ensure proper treatment in an ...

  20. Medical ice slurry production device

    DOEpatents

    Kasza, Kenneth E.; Oras, John; Son, HyunJin

    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.

  1. [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

  2. 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.

  3. MRI compatibility and visibility assessment of implantable medical devices.

    PubMed

    Schueler, B A; Parrish, T B; Lin, J C; Hammer, B E; Pangrle, B J; Ritenour, E R; Kucharczyk, J; Truwit, C L

    1999-04-01

    We have developed a protocol to evaluate the magnetic resonance (MR) compatibility of implantable medical devices. The testing protocol consists of the evaluation of magnetic field-induced movement, electric current, heating, image distortion, and device operation. In addition, current induction is evaluated with a finite element analysis simulation technique that models the effect of radiofrequency fields on each device. The protocol has been applied to several implantable infusion pumps and neurostimulators with associated attachments. Experiments were performed using a 1.5-T whole-body MR system with parameters selected to approximate the intended clinical and worst case configuration. The devices exhibited moderate magnetic field-induced deflection and torque but had significant image artifacts. No heating was detected for any of the devices. Pump operation was halted in the magnetic field, but resumed after removed. Exposure to the magnetic field activated some of the neurostimulators. PMID:10232520

  4. [Perspectives on the supervision of medical device software].

    PubMed

    Li, Jun; Yang, Guozhong

    2011-05-01

    Medical device software is a special kind of medical device, which is different from hardware and may introduce more risk. How to reduce the risk of software efficiently is the important thing for medical device regulation system. This article analyzes medical device software's properties, introduces the status of foreign supervision, and finally gives some advises to the related parties. PMID:21954581

  5. Medical hyperspectral imaging: a review

    NASA Astrophysics Data System (ADS)

    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.

  6. 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

  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. 77 FR 19293 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-30

    ... the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. Submit... INFORMATION: Name of Committee: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory... with or considering hip replacement (...

  9. 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... (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...

  10. 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...

  11. 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...

  12. 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...

  13. 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.

  14. 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......

  15. Electron beam sterilisation of heterogeneous medical devices

    NASA Astrophysics Data System (ADS)

    Sadat, T.; Morisseau, MrD.; Ross, MissA.

    1993-07-01

    Electron beam radiation is used in the sterilisation of medical disposable devices. High energy, 10 MeV, electron beam linear accelerators are in use worldwide for this purpose. The dose distribution achieved in the products treated influences the efficiency of treatment. This paper looks at the dose distribution achieved with such machines and the methods used to define it in heterogeneous products.

  16. 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

  17. 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

  18. 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. PMID:12397833

  19. 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.

  20. Medical devices; classification for medical washer and medical washer-disinfector. Final rule.

    PubMed

    2002-11-15

    The Food and Drug Administration (FDA) is classifying the medical washer and medical washer-disinfector intended for general medical purposes to clean and dry surgical instruments, decontaminate or disinfect anesthesia equipment, hollowware, and other medical devices into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors" (the guidance) as the special control that, in addition to general controls, the agency believes will reasonably ensure the safety and effectiveness of the device. 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 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (the FDAMA). PMID:12437015

  1. Data sources: use in the epidemiologic study of medical devices.

    PubMed

    Torrence, Mary E

    2002-05-01

    Medical device epidemiology is the study of the prevalence and incidence of use, effectiveness, and adverse events associated with medical devices in a population. The identification of large data sources with medical device data provides a large population for epidemiologic studies. Two challenges in medical device epidemiology are the ability to find data on the specific device and the exposure of a patient to that device. This paper identifies data sources both from the govenment and from the private sector that can be used for epidemiologic studies of medical devices and, to a limited degree, studies of medical devices in women. Each source provides data for different types of devices and in differing specificity. The paper also discusses briefly the strengths and weaknesses of each data source. More data sources are needed to enhance the study of medical device epidemiology. Additional efforts and focus are needed to enhance the ability to study medical devices in women. PMID:12071476

  2. 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

  3. 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

  4. Power Approaches for Implantable Medical Devices.

    PubMed

    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

  5. DICOM: a standard for medical imaging

    NASA Astrophysics Data System (ADS)

    Horii, Steven C.; Bidgood, W. Dean

    1993-01-01

    Since 1983, the American College of Radiology (ACR) and the National Electrical Manufacturers Association (NEMA) have been engaged in developing standards related to medical imaging. This alliance of users and manufacturers was formed to meet the needs of the medical imaging community as its use of digital imaging technology increased. The development of electronic picture archiving and communications systems (PACS), which could connect a number of medical imaging devices together in a network, led to the need for a standard interface and data structure for use on imaging equipment. Since medical image files tend to be very large and include much text information along with the image, the need for a fast, flexible, and extensible standard was quickly established. The ACR-NEMA Digital Imaging and Communications Standards Committee developed a standard which met these needs. The standard (ACR-NEMA 300-1988) was first published in 1985 and revised in 1988. It is increasingly available from equipment manufacturers. The current work of the ACR- NEMA Committee has been to extend the standard to incorporate direct network connection features, and build on standards work done by the International Standards Organization in its Open Systems Interconnection series. This new standard, called Digital Imaging and Communication in Medicine (DICOM), follows an object-oriented design methodology and makes use of as many existing internationally accepted standards as possible. This paper gives a brief overview of the requirements for communications standards in medical imaging, a history of the ACR-NEMA effort and what it has produced, and a description of the DICOM standard.

  6. Medical device data systems and FDA regulation. Should medical device data systems require FDA clearance?

    PubMed

    Kelley, Peter

    2010-01-01

    It is widely understood why medical devices need to be regulated by the FDA and other governing bodies. However medical software does not typically require the same level of regulation. Currently the FDA is investigating whether one type of medical software, Medical Device Data Systems (MDDS), should require FDA clearance because of the potential risk they impose when interconnected with medical devices. Hospitals are looking to implement MDDS because the technology allows nursing staff to spend more time on direct patient care and reduces charting errors. This article will explore the FDA's proposal and will review the possible risks and provide a rationale for why MDDS should be regulated by the FDA and why MDDS vendors should have the right level of quality and risk management procedures in place to ensure that they are developing and bringing to market the safest products possible. PMID:20677470

  7. [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. PMID:27197502

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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

  14. 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.

  15. 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.

  16. 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...

  17. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    .../MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm or by sending an email request... HUMAN SERVICES Food and Drug Administration 21 CFR Part 890 Medical Devices; Exemption From Premarket... Part 890 Medical devices, Physical medicine devices. Therefore, under the Federal Food, Drug,...

  18. An open architecture for medical image workstation

    NASA Astrophysics Data System (ADS)

    Liang, Liang; Hu, Zhiqiang; Wang, Xiangyun

    2005-04-01

    Dealing with the difficulties of integrating various medical image viewing and processing technologies with a variety of clinical and departmental information systems and, in the meantime, overcoming the performance constraints in transferring and processing large-scale and ever-increasing image data in healthcare enterprise, we design and implement a flexible, usable and high-performance architecture for medical image workstations. This architecture is not developed for radiology only, but for any workstations in any application environments that may need medical image retrieving, viewing, and post-processing. This architecture contains an infrastructure named Memory PACS and different kinds of image applications built on it. The Memory PACS is in charge of image data caching, pre-fetching and management. It provides image applications with a high speed image data access and a very reliable DICOM network I/O. In dealing with the image applications, we use dynamic component technology to separate the performance-constrained modules from the flexibility-constrained modules so that different image viewing or processing technologies can be developed and maintained independently. We also develop a weakly coupled collaboration service, through which these image applications can communicate with each other or with third party applications. We applied this architecture in developing our product line and it works well. In our clinical sites, this architecture is applied not only in Radiology Department, but also in Ultrasonic, Surgery, Clinics, and Consultation Center. Giving that each concerned department has its particular requirements and business routines along with the facts that they all have different image processing technologies and image display devices, our workstations are still able to maintain high performance and high usability.

  19. 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.

  20. 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.

  1. 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...

  2. 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 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;...

  3. 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

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory... of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function... intervention for patients who have failed maximal medical management. Of note, the CoAxia NeuroFlo Catheter...

  4. 77 FR 18829 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... HUMAN SERVICES Food and Drug Administration Gastroenterology and Urology Devices Panel of the Medical... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide... related to medical devices intended for obese patients. The committee will provide...

  5. 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. PMID:23686179

  6. 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.

  7. Multispectral fluorescence imaging device for malignancy detection

    NASA Astrophysics Data System (ADS)

    Bocher, Thomas; Luhmann, Till; Baier, S.; Dierolf, Marc; Naumann, M.; Beuthan, Juergen; Berlien, Hans-Peter; Mueller, Gerhard J.

    1997-12-01

    In medical diagnosis of superficial lesions at inner or outer surfaces of the human body fluorescence imaging techniques are able to deliver additional information on the metabolic and structural state of the observed tissue. To subtract background fluorescence and to achieve a differential diagnosis a multispectral analysis in several wavelength windows is needed. Additionally, special image algorithms have to be applied which depend on the examined malignancy. For this purpose a multispectral fluorescence imaging device was developed. It can be used both endoscopically and in combination with a standard operational microscope from Carl Zeiss, Germany. In this paper, the device and first clinical results are presented. The device was built to detect superficial lesions like tumors, inflammations, etc. Target chromophores are NADH, Protoporphyrin IX, collagen and other. The measured optical bands are (405 plus or minus 5) nm, (442 plus or minus 5) nm, (458 plus or minus 5) nm, (550 plus or minus 5) nm, (630 plus or minus 5) nm and (690 plus or minus 5) nm. A special UV-source with a liquid light guide is used as the illumination source in two excitation bands of (365 plus or minus 10) nm and (420 plus or minus 20) nm. First clinical investigations of superficial malignancies like squamous cell carcinoma and basalioma are presented.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. Regulatory science based approach in development of novel medical devices.

    PubMed

    Sakuma, Ichiro

    2015-08-01

    For development rational evaluation method for medical devices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medical device under development should be conducted as well as its technological development. Clinical performance of a medical device is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medical device is accepted. Setting of appropriate end points is required to evaluate a medical device appropriately. Risk assessment and risk management are the basis of medical device safety assurance. In case of medical device software, there are difficulties in identifying the risk due to its complexity of user environment and different design and manufacturing procedure compared with conventional hardware based medical devices. Recent technological advancement such as information and communication technologies (ICT) for medical devices and wireless network has raised new issue on risk management: cybersecurity. We have to watch closely the progress of safety standard development. PMID:26736611

  13. A system for ultrasonic beacon-guidance of catheters and other minimally-invasive medical devices.

    PubMed

    Vilkomerson, D; Lyons, D

    1997-01-01

    Catheters and other interventional medical devices are presently guided by X-ray imaging, despite the advantages of ultrasound imaging over X-ray imaging in cost, safety, and availability. X-ray imaging is used because ultrasound reflects specularly from catheters and similar devices; their visibility is highly angle-dependent. With an omni-directional receiver mounted on a device, the receiver's location in the ultrasound image can be deduced from knowing which acoustic ray struck the receiver and the time from transmission of the imaging pulse to its reception by the receiver. This information is independent of specular reflection. The location of the device can then be indicated in the ultrasound image by an arrow pointing to the sensor, making possible ultrasound guidance of these devices. This paper describes the technical and practical considerations in the design and construction of the device-mounted receiver and associated electronics, and describes some clinical uses. PMID:18244147

  14. Medical Imaging of Hyperpolarized Gases

    NASA Astrophysics Data System (ADS)

    Miller, G. Wilson

    2009-08-01

    Since the introduction of hyperpolarized 3He and 129Xe as gaseous MRI contrast agents more than a decade ago, a rich variety of imaging techniques and medical applications have been developed. Magnetic resonance imaging of the inhaled gas depicts ventilated lung airspaces with unprecedented detail, and allows one to track airflow and pulmonary mechanics during respiration. Information about lung structure and function can also be obtained using the physical properties of the gas, including spin relaxation in the presence of oxygen, restricted diffusion inside the alveolar airspaces, and the NMR frequency shift of xenon dissolved in blood and tissue.

  15. 76 FR 21237 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-15

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 884 Medical Devices; Obstetrical and... these specific medical devices under 21 U.S.C. 360k, even though product sponsors may have flexibility...., August 17, 2009. List of Subjects in 21 CFR Part 884 Medical devices. Therefore, under the Federal...

  16. Production of Medical Device Using MIM Technique

    NASA Astrophysics Data System (ADS)

    Omar, M. A.; Mustapha, M.; Ali, E. A. G. E.; Subuki, I.; Meh, B.

    2010-03-01

    Metal Injection moulding (MIM) is an advanced near net shape forming process. This paper presents the attempt to manufacture medical devices particularly fracture fixation plates for orthopedic applications for commercial purposes by MIM process. The stainless steel powder with the median particle size of 15 μm and a binder consisting of polyethylene, paraffin wax and stearic acid were mixed at 160° C using a sigma-blade mixer for one hour to prepare the feedstock of the fracture fixation plates. The fracture fixation plate component was injection molded using vertical injection moulding machine with the nozzle temperature of 200° C. Prior to sintering, the specimens were debound using a combination of solvent extraction and thermal pyrolysis method. The specimens were then sintered under vacuum. The properties of the fracture fixation plates such as physical and mechanical properties were presented and discussed. The in-vitro biocompatibility study on the fracture plates produced was examined.

  17. 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. PMID:25279540

  18. 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.

  19. 76 FR 7220 - Medical Device Innovation Initiative; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

    ... HUMAN SERVICES Food and Drug Administration Medical Device Innovation Initiative; Request for Comments... Innovation Initiative'' (the report). The report proposes potential actions for FDA's Center for Devices and... global leader in medical device innovation and CDRH is committed to assuring that American patients...

  20. 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. PMID:17238733

  1. 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...

  2. 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...

  3. 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...

  4. 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

    ... 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. 76 FR 6625 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory... Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Embolization Device (PED), sponsored by Chestnut Medical. The PED is indicated for the endovascular...

  6. 77 FR 73034 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ... 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...

  7. 76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide... HUMAN SERVICES Food and Drug Administration Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION:...

  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. 78 FR 13350 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... 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...

  10. 76 FR 14414 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: Microbiology Devices Panel of the Medical Devices Advisory...

  11. 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

  12. Charge coupled device image sensor study

    NASA Technical Reports Server (NTRS)

    1974-01-01

    An evaluation of a charge-coupled device (CCD) image sensors for use in spacecraft-borne imaging systems was conducted. The study resulted in design recommendations for two sensors, an approximately 500 times 500 element imaging device and a 1 times 190 element linear imaging device with a 190 times 121 buffer store. Emphasis was placed on the higher resolution, area-imaging sensor. The objectives of the proposed sensors are listed, results of the experiments are analyzed, and estimates of the device performance are presented. A summary of the major technical recommendations is included.

  13. 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. PMID:23559585

  14. 76 FR 67463 - Pediatric Medical Devices; Public Workshop; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-01

    ... medical devices and pediatric device approvals or clearance; the scientific and regulatory limitations and... to support pediatric effectiveness claims for medical devices and pediatric device approvals or... HUMAN SERVICES Food and Drug Administration Pediatric Medical Devices; Public Workshop; Request...

  15. 75 FR 69447 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-12

    ... Collection; Comment Request; Medical Devices; Device Tracking AGENCY: Food and Drug Administration, HHS... device information is collected to facilitate identifying the current location of medical devices and... solicits comments on information collection requirements for the tracking of medical devices. DATES:...

  16. Medical devices: classification of the dental sonography device and jaw tracking device. Final rule.

    PubMed

    2003-12-01

    The Food and Drug Administration (FDA) is classifying the dental sonography device into class I, when it is used to monitor temporomandibular joint sounds, and into class II, when it is used to interpret temporomandibular joint sounds for the diagnosis of temporomandibular joint disorders and associated orofacial pain. FDA is classifying the jaw tracking device into class I, when it is used to monitor mandibular jaw positions relative to the maxilla, and into class II, when it is used to interpret mandibular jaw positions relative to the maxilla, for the diagnosis of temporomandibular joint disorders and associated orofacial pain. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device. FDA is taking this action 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 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). PMID:14651050

  17. 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

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

    PubMed

    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

  19. 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.

  20. 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.

  1. 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. ...

  2. Despeckling of Medical Ultrasound Images

    PubMed Central

    Michailovich, Oleg V.; Tannenbaum, Allen

    2013-01-01

    Speckle noise is an inherent property of medical ultrasound imaging, and it generally tends to reduce the image resolution and contrast, thereby reducing the diagnostic value of this imaging modality. As a result, speckle noise reduction is an important prerequisite, whenever ultrasound imaging is used for tissue characterization. Among the many methods that have been proposed to perform this task, there exists a class of approaches that use a multiplicative model of speckled image formation and take advantage of the logarithmical transformation in order to convert multiplicative speckle noise into additive noise. The common assumption made in a dominant number of such studies is that the samples of the additive noise are mutually uncorrelated and obey a Gaussian distribution. The present study shows conceptually and experimentally that this assumption is oversimplified and unnatural. Moreover, it may lead to inadequate performance of the speckle reduction methods. The study introduces a simple preprocessing procedure, which modifies the acquired radio-frequency images (without affecting the anatomical information they contain), so that the noise in the log-transformation domain becomes very close in its behavior to a white Gaussian noise. As a result, the preprocessing allows filtering methods based on assuming the noise to be white and Gaussian, to perform in nearly optimal conditions. The study evaluates performances of three different, nonlinear filters—wavelet denoising, total variation filtering, and anisotropic diffusion—and demonstrates that, in all these cases, the proposed preprocessing significantly improves the quality of resultant images. Our numerical tests include a series of computer-simulated and in vivo experiments. PMID:16471433

  3. Despeckling of medical ultrasound images.

    PubMed

    Michailovich, Oleg V; Tannenbaum, Allen

    2006-01-01

    Speckle noise is an inherent property of medical ultrasound imaging, and it generally tends to reduce the image resolution and contrast, thereby reducing the diagnostic value of this imaging modality. As a result, speckle noise reduction is an important prerequisite, whenever ultrasound imaging is used for tissue characterization. Among the many methods that have been proposed to perform this task, there exists a class of approaches that use a multiplicative model of speckled image formation and take advantage of the logarithmical transformation in order to convert multiplicative speckle noise into additive noise. The common assumption made in a dominant number of such studies is that the samples of the additive noise are mutually uncorrelated and obey a Gaussian distribution. The present study shows conceptually and experimentally that this assumption is oversimplified and unnatural. Moreover, it may lead to inadequate performance of the speckle reduction methods. The study introduces a simple preprocessing procedure, which modifies the acquired radio-frequency images (without affecting the anatomical information they contain), so that the noise in the log-transformation domain becomes very close in its behavior to a white Gaussian noise. As a result, the preprocessing allows filtering methods based on assuming the noise to be white and Gaussian, to perform in nearly optimal conditions. The study evaluates performances of three different, nonlinear filters--wavelet denoising, total variation filtering, and anisotropic diffusion--and demonstrates that, in all these cases, the proposed preprocessing significantly improves the quality of resultant images. Our numerical tests include a series of computer-simulated and in vivo experiments. PMID:16471433

  4. Novel Algorithm for Classification of Medical Images

    NASA Astrophysics Data System (ADS)

    Bhushan, Bharat; Juneja, Monika

    2010-11-01

    Content-based image retrieval (CBIR) methods in medical image databases have been designed to support specific tasks, such as retrieval of medical images. These methods cannot be transferred to other medical applications since different imaging modalities require different types of processing. To enable content-based queries in diverse collections of medical images, the retrieval system must be familiar with the current Image class prior to the query processing. Further, almost all of them deal with the DICOM imaging format. In this paper a novel algorithm based on energy information obtained from wavelet transform for the classification of medical images according to their modalities is described. For this two types of wavelets have been used and have been shown that energy obtained in either case is quite distinct for each of the body part. This technique can be successfully applied to different image formats. The results are shown for JPEG imaging format.

  5. Calibrated parametric medical ultrasound imaging.

    PubMed

    Valckx, F M; Thijsse, J M; van Geemen, A J; Rotteveel, J J; Mullaart, R

    2000-01-01

    The goal of this study was to develop a calibrated on-line technique to extract as much diagnostically-relevant information as possible from conventional video-format echograms. The final aim is to improve the diagnostic potentials of medical ultrasound. Video-output images were acquired by a frame grabber board incorporated in a multiprocessor workstation. Calibration images were obtained from a stable tissue-mimicking phantom with known acoustic characteristics. Using these images as reference, depth dependence of the gray level could fairly be corrected for the transducer performance characteristics, for the observer-dependent equipment settings and for attenuation in the examined tissues. Second-order statistical parameters still displayed some nonconsistent depth dependencies. The results obtained with two echoscanners for the same phantom were different; hence, an a posteriori normalization of clinical data with the phantom data is indicated. Prior to processing of clinical echograms,. the anatomical reflections and echoless voids were removed automatically. The final step in the preprocessing concerned the compensation of the overall attenuation in the tissue. A 'sliding window' processing was then applied to a region of interest (ROI) in the 'back-scan converted' images. A number of first and second order statistical texture parameters and acoustical parameters were estimated in each window and assigned to the central pixel. This procedure results in a set of new 'parametric' images of the ROI, which can be inserted in the original echogram (gray value, color) or presented as a color overlay. A clinical example is presented for illustrating the potentials of the developed technique. Depending on the choice of the parameters, four full resolution calibrated parametric images can be calculated and simultaneously displayed within 5 to 20 seconds. In conclusion, an on-line technique has been developed to estimate acoustic and texture parameters with a reduced

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

    PubMed Central

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

    2016-01-01

    Objective To investigate the regulatory approval of new medical devices. Design Cross sectional study of new medical devices reported in the biomedical literature. Data sources 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. Eligibility criteria for study selection 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.” Main outcome measures 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. Results 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. Conclusions 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. PMID:27207165

  7. 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

  8. Medical Image Retrieval: A Multimodal Approach.

    PubMed

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Through the approaches announced in this guidance, FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk......

  10. 75 FR 55803 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

    ... 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... a disability, please contact AnnMarie Williams, Conference Management Staff, at 301-796-5966...

  11. 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. PMID:25991287

  12. 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

  13. Managing the medical device directive. A practical case study.

    PubMed

    Nielsen, M

    1995-11-01

    Through a case study of a fictional company, this article provides a guide on how to implement CE-marking procedures, as detailed in the Medical Device Directive. The overlap in transitional periods between the Medical Device and Electromagnetic Compatibility Directives is discussed, together with issues such as selection of conformity assessment routes. PMID:10158130

  14. 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. PMID:19964137

  15. Medical Imaging Physics, 4th Edition

    NASA Astrophysics Data System (ADS)

    Hendee, William R.; Ritenour, E. Russell

    2002-05-01

    This comprehensive publication covers all aspects of image formation in modern medical imaging modalities, from radiography, fluoroscopy, and computed tomography, to magnetic resonance imaging and ultrasound. It addresses the techniques and instrumentation used in the rapidly changing field of medical imaging. Now in its fourth edition, this text provides the reader with the tools necessary to be comfortable with the physical principles, equipment, and procedures used in diagnostic imaging, as well as appreciate the capabilities and limitations of the technologies.

  16. 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

  17. 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

  18. 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. PMID:21142522

  19. 76 FR 36993 - Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... CFR Part 882 Medical devices, Neurological devices. Therefore, under the Federal Food, Drug, and... Devices; Neurological Devices; Clarification of Classification for Human Dura Mater; Technical Amendment...). In the Federal Register of November 24, 2004 (69 FR 68612), FDA published a final rule...

  20. 78 FR 77689 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide... Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... published a proposed rule (44 FR 50520) for classification of iontophoresis devices for specialized...

  1. Medical Devices in the Treatment of Obesity.

    PubMed

    Chang, Julietta; Brethauer, Stacy

    2016-09-01

    Obesity continues to be a growing epidemic worldwide. Although bariatric surgery remains the most effective and durable treatment of obesity and its comorbidities, there is a need for less invasive yet efficacious weight loss therapies. Currently the Food and Drug Administration has approved two endoscopically placed intragastric balloon devices and a surgically placed vagal blockade device. Another device that holds promise, particularly for the treatment of type 2 diabetes, is the endoscopically placed duodenojejunal bypass sleeve. This article reviews the indications and current data regarding results for these devices. PMID:27519137

  2. 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.

  3. 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. PMID:20236065

  4. 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.

  5. Perceptually lossless wavelet-based compression for medical images

    NASA Astrophysics Data System (ADS)

    Lin, Nai-wen; Yu, Tsaifa; Chan, Andrew K.

    1997-05-01

    In this paper, we present a wavelet-based medical image compression scheme so that images displayed on different devices are perceptually lossless. Since visual sensitivity of human varies with different subbands, we apply the perceptual lossless criteria to quantize the wavelet transform coefficients of each subband such that visual distortions are reduced to unnoticeable. Following this, we use a high compression ratio hierarchical tree to code these coefficients. Experimental results indicate that our perceptually lossless coder achieves a compression ratio 2-5 times higher than typical lossless compression schemes while producing perceptually identical image content on the target display device.

  6. 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. PMID:25956618

  7. [Data transparency regarding medical devices - the position of the medical device industry].

    PubMed

    Soskuty, Gabriela

    2011-01-01

    The medical device industry, strongly dominated by medium-sized firms, has significant growth potential and a high number of job opportunities with 170,000 employees in more than 11,000 companies. Approximately one third of the business volume is achieved with innovative products that are less than three years old. The safety, quality and efficiency of the products is tested and approved by CE certification. Due to the heterogeneous field of devices, however, evidence requirements must be differentiated according to the type of device in question. Transparency is as important as the type of evidence, and industry is well aware of the significance of transparency for credibility in the market. Industry believes that all the stakeholders affected must collaborate to define the evidence requirements and decide which data are necessary to assess the benefits of a technology. Before a consistent level of transparency can be achieved, however, it is crucial to jointly develop a framework of requirements including invasiveness, risk potential, patient-relevant endpoints and intended use of the technology, as well as the data source. Transparency is a process that can only be achieved if all stakeholders cooperate successfully. Also, it is important to keep in mind that the development of study designs and reliable evidence needs time. In the interest of all patients it is essential to maintain an innovation-friendly climate in Germany. PMID:21530908

  8. 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

  9. Medical devices; laser fluorescence caries detection device. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-04-01

    The Food and Drug Administration (FDA) is classifying the laser fluorescence caries detection device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:11010622

  10. 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

  11. 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. PMID:26415828

  12. 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. PMID:25694857

  13. 77 FR 72924 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ... rulemaking (REG-113770-10) (the proposed regulations) in the Federal Register (77 FR 6028). The IRS and the... ``Intended for Humans'' A number of commenters suggested that certain devices, such as sterilization...

  14. Medical devices; gastroenterology-urology devices; nonimplanted, peripheral electrical continence device. Food and Drug Administration, HHS. Final rule.

    PubMed

    2000-04-01

    The Food and Drug Administration (FDA) is classifying the nonimplanted, peripheral electrical continence device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:11010624

  15. Compact integral three-dimensional imaging device

    NASA Astrophysics Data System (ADS)

    Arai, J.; Yamashita, T.; Hiura, H.; Miura, M.; Funatsu, R.; Nakamura, T.; Nakasu, E.

    2015-05-01

    A compact integral three-dimensional (3D) imaging device for capturing high resolution 3D images has been developed that positions the lens array and image sensor close together. Unlike the conventional scheme, where a camera lens is used to project the elemental images generated by the lens array onto the image sensor, the developed device combines the lens array and image sensor into one unit and makes no use of a camera lens. In order to capture high resolution 3D images, a high resolution imaging sensor and a lens array composed of many elemental lenses are required, and in an experimental setup, a CMOS image sensor circuit patterned with multiple exposures and a multiple lens array were used. Two types of optics were implemented for controlling the depth of 3D images. The first type was a convex lens that is suitable for compressing a relatively large object space, and the second was an afocal lens array that is suitable for capturing a relatively small object space without depth distortion. The objects captured with the imaging device and depth control optics were reconstructed as 3D images by using display equipment consisting of a liquid crystal panel and a lens array. The reconstructed images were found to have appropriate motion parallax.

  16. 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.

  17. Medical Devices that Treat Obesity: What to Know

    MedlinePlus

    ... For Consumers Consumer Updates Medical Devices that Treat Obesity: What to Know Share Tweet Linkedin Pin it ... be less invasive.” back to top How is obesity measured? Obesity is typically measured by calculating body ...

  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 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. PMID:10128335

  20. When medical devices fail: Lessons learned in a hemodialysis unit.

    PubMed

    Phillips, J Matthew; Mossop, Paula; Bartol, Carolyn; Hodgson, Barbara

    2015-01-01

    Technology and medical equipment devices have become integrated in the delivery of health care. These technologies and devices can introduce new risks, either through user error or malfunction. When these incidents occur, it is important they are reported so that learning and improvements are possible. A just culture encourages reporting of incidents by not blaming individuals, but rather by seeking to understand incidents in relation to how they occurred because of the systems in place. These concepts are explored through a case study in a dialysis unit where a malfunction of a medical equipment device (central venous catheter) was identified. The process for addressing the issue is defined and includes reviewing applicable data, reporting incidents, and evaluating devices that malfunctioned. Finally, the role of the frontline health care professional is identified as an important stakeholder in identifying issues with technology and medical devices, reporting these incidents, and participating in the process that resolves the issues. PMID:26901981

  1. 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. PMID:25230354

  2. 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.

  3. 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.

  4. 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

  5. Development of implantable medical devices: from an engineering perspective.

    PubMed

    Joung, Yeun-Ho

    2013-09-01

    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

  6. 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

    ... 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... Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. General...

  7. 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

    ... Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of July 14, 2011 (76 FR 41507). The amendment is being made to reflect a... HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the...

  8. 77 FR 12064 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-28

    ... HUMAN SERVICES Food and Drug Administration Radiological Devices Panel of the Medical Devices Advisory... Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to... April 9, 2009 (74 FR 16214), for breast transilluminators, one of the remaining preamendments class...

  9. 77 FR 71195 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-29

    ... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide... Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if made final, would make...

  10. 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

    ... Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee scheduled for April 5, 2013. The meeting was announced in the Federal Register of November 29, 2012 (77 FR 71195). The meeting... Devices Advisory Committee: Notice of Postponement of Meeting AGENCY: Food and Drug Administration,...

  11. 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...

  12. 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

    ... in the Federal Register of August 9, 2011 (76 FR 48871). The meeting is postponed so that FDA can... 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. The medical information bus: overview of the medical device data language.

    PubMed

    Gottschalk, H W

    1991-01-01

    The Medical Information Bus (MIB) reference model defines a new, object-oriented Medical Device Data Language (MDDL), under development by the Institute of Electrical and Electronic Engineers Society (IEEE) P1073 MIB Standard Committee. The MDDL treats medical devices, host computers, humans and device parameters as objects, and provides a flexible and extensible language for describing and passing messages between objects. This paper describes the MDDL semantic reference model and presents an overview of the MDDL structure, within the framework of the International Standards Organization (ISO) System Management Overview (SMO) model. A simple example of how the MDDL can be used to construct a device event report is also described. PMID:10114051

  18. 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.

  19. 77 FR 8260 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ... Collection; Comment Request; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor... solicits comments on medical device reporting (MDR); manufacturer, importer, user facility, and distributor... appropriate, and other forms of information technology. Medical Device Reporting: Manufacturer, Importer,...

  20. 76 FR 71041 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-16

    ... Collection; Comment Request; Medical Device Recall Authority AGENCY: Food and Drug Administration, HHS... on the information collection requirements for medical device recall authority. DATES: Submit either... of information technology. Medical Device Recall Authority--21 CFR Part 810 (OMB Control Number...

  1. Seeing it through: translational validation of new medical imaging modalities

    PubMed Central

    Aldrich, Melissa B.; Marshall, Milton V.; Sevick-Muraca, Eva M.; Lanza, Greg; Kotyk, John; Culver, Joseph; Wang, Lihong V.; Uddin, Jashim; Crews, Brenda C.; Marnett, Lawrence J.; Liao, Joseph C.; Contag, Chris; Crawford, James M.; Wang, Ken; Reisdorph, Bill; Appelman, Henry; Turgeon, D. Kim; Meyer, Charles; Wang, Tom

    2012-01-01

    Medical imaging is an invaluable tool for diagnosis, surgical guidance, and assessment of treatment efficacy. The Network for Translational Research (NTR) for Optical Imaging consists of four research groups working to “bridge the gap” between lab discovery and clinical use of fluorescence- and photoacoustic-based imaging devices used with imaging biomarkers. While the groups are using different modalities, all the groups face similar challenges when attempting to validate these systems for FDA approval and, ultimately, clinical use. Validation steps taken, as well as future needs, are described here. The group hopes to provide translational validation guidance for itself, as well as other researchers. PMID:22574264

  2. 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.

  3. Wavelet compression efficiency investigation for medical images

    NASA Astrophysics Data System (ADS)

    Moryc, Marcin; Dziech, Wiera

    2006-03-01

    Medical images are acquired or stored digitally. These images can be very large in size and number, and compression can increase the speed of transmission and reduce the cost of storage. In the paper analysis of medical images' approximation using the transform method based on wavelet functions is investigated. The tested clinical images are taken from multiple anatomical regions and modalities (Computer Tomography CT, Magnetic Resonance MR, Ultrasound, Mammography and X-Ray images). To compress medical images, the threshold criterion has been applied. The mean square error (MSE) is used as a measure of approximation quality. Plots of the MSE versus compression percentage and approximated images are included for comparison of approximation efficiency.

  4. Denoising Medical Images using Calculus of Variations

    PubMed Central

    Kohan, Mahdi Nakhaie; Behnam, Hamid

    2011-01-01

    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. PMID:22606674

  5. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. (c) U.S. financial institutions are authorized to conduct all... 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. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 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,...

  7. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 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,...

  8. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. (c) U.S. financial institutions are authorized to conduct all... 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...

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

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. (c) U.S. financial institutions are authorized to conduct all... 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...

  10. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 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,...