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.

  2. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  3. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  4. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  5. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  6. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  7. 21 CFR 892.2010 - 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 892.2010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device....

  8. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  9. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  10. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  11. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  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 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image...

  13. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  14. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  15. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  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 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image...

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

    PubMed

    Qiu, Minghui

    2013-09-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2014-02-01

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

  19. Medical Device Safety

    MedlinePlus

    ... Home Medical Devices Medical Device Safety Medical Device Safety Share Tweet Linkedin Pin it More sharing options ... 17 More Medical Device Recalls Recent Medical Device Safety Communications FDA analyses and recommendations for patients and ...

  20. 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.

  1. 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.

  2. 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.

  3. 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 ...

  4. 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.

  5. Medical devices: US medical device regulation.

    PubMed

    Jarow, Jonathan P; Baxley, John H

    2015-03-01

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

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

    PubMed Central

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

    2014-01-01

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

  7. 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...

  8. Medical devices; obstetrical and gynecological devices; classification of the assisted reproduction embryo image assessment system. Final order.

    PubMed

    2015-02-26

    The Food and Drug Administration (FDA) is classifying the Assisted Reproduction Embryo Image Assessment System into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the Assisted Reproduction Embryo Image Assessment System classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

  9. [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.

  10. Medical imaging

    NASA Astrophysics Data System (ADS)

    Elliott, Alex

    2005-07-01

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

  11. 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...

  12. Optomechanical medical devices (instruments)

    NASA Astrophysics Data System (ADS)

    Reiss, Roger S.

    2004-03-01

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

  13. 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

  14. Medical imaging

    SciTech Connect

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

    1987-01-01

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

  15. 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…

  16. Device for wavelength-selective imaging

    SciTech Connect

    Frangioni, John V.

    2010-09-14

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

  17. 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.

  18. 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

    ... CT devices that allow very thin slices, etc.). 1. What hardware and software features should... procedures so that they incorporate the ALARA concept (maintaining dose As Low As Reasonably Achievable) and... common clinical applications for which the device could be used (such as those requiring special...

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

    NASA Astrophysics Data System (ADS)

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

    2009-02-01

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

  20. 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

  1. Assurance Cases for Medical Devices

    DTIC Science & Technology

    2011-04-28

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

  2. 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.

  3. Reducing Risks Associated with Medical Device Misconnections

    MedlinePlus

    ... Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices ... Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products

  4. 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.

  5. 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...

  6. 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.

  7. 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.

  8. Recent medical devices for tonsillectomy.

    PubMed

    Sayin, I; Cingi, C

    2012-01-01

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

  9. [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.

  10. 78 FR 18233 - Medical Devices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

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

  11. 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.

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

    PubMed

    Yang, Wanjuan; Li, Jun; Li, Jingli

    2014-09-01

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

  13. Multiregional medical device development: regulatory perspective.

    PubMed

    Tamura, Atsushi; Kutsumi, Hiromu

    2014-04-01

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

  14. 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.

  15. 21 CFR 892.2030 - Medical image digitizer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  16. 21 CFR 892.2030 - Medical image digitizer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  17. 21 CFR 892.2030 - Medical image digitizer.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  18. 21 CFR 892.2030 - Medical image digitizer.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  19. 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.

  20. The Universal Medical Device Nomenclature System.

    PubMed

    Gaev, J A

    1996-01-01

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

  1. Overview of Medical Imaging

    NASA Astrophysics Data System (ADS)

    Hendee, William

    2008-03-01

    The use of radiation probes to image tissues in the human body has progressed through an extraordinary evolution in the past three decades. Beginning with transmission computed tomography in the 1970s, this evolution has included real-time ultrasound, emission computed tomography, magnetic resonance imaging and digital radiography. These advances have recently yielded major improvements in imaging such as multi-detector transmission computed tomography, functional magnetic resonance imaging, dual imaging modalities built on a common platform, and image-guided intervention. These improvements and others have accelerated the usefulness of imaging methods in the early detection, definitive diagnosis, and effective intervention of a wide spectrum of diseases and disabilities. They also have led to increases in radiation doses to patients and the population, an issue of major concern to physicists and physicians. At this time there are four major frontiers for research in medical imaging: (1) molecular imaging; (2) functional imaging; (3) multi-modality imaging; and (4) information management. These research frontiers, together with the use of sophisticated imaging technologies in clinical practice, offer rich professional opportunities for physicists.

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

    PubMed

    Peng, Liang; Liu, Xiaoyan

    2015-01-01

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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 78 FR 15877 - Taxable Medical Devices; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

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

  8. 77 FR 6028 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

    ... instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or...) whether the device generally must be implanted, inserted, operated, or otherwise administered by a medical... subject to an IDE is not a ``taxable medical device'' under the proposed regulations. VI....

  9. 21 CFR 892.2030 - Medical image digitizer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  10. Medical devices and patient safety.

    PubMed

    Mattox, Elizabeth

    2012-08-01

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

  11. [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.

  12. 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.

  13. 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.

  14. Wavelets in medical imaging

    NASA Astrophysics Data System (ADS)

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

    2012-07-01

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

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

    PubMed

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

    2013-06-01

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

  16. Privacy Challenges for Wireless Medical Devices

    SciTech Connect

    Lagesse, Brent J

    2010-01-01

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

  17. 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.

  18. 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.

  19. Medical Image Analysis Facility

    NASA Technical Reports Server (NTRS)

    1978-01-01

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

  20. Intrauterine device (image)

    MedlinePlus

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

  1. Anti-thrombotic technologies for medical devices.

    PubMed

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

    2016-08-03

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

  2. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  3. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  4. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  5. 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...

  6. Mobile medical device connectivity: real world solutions.

    PubMed

    Pettus, Dan

    2004-01-01

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

  7. 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.

  8. 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 ...

  9. 78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

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

  10. 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

  11. Home Healthcare Medical Devices: A Checklist

    MedlinePlus

    ... not using it. Contact your doctor and home healthcare team often to review your health condition. * Check ... assurance of their safety and effectiveness. A home healthcare medical device is any product or equipment used ...

  12. Proposed amendments to the medical devices Directives.

    PubMed

    Donawa, Maria

    2006-01-01

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

  13. [Maintenance and obsolescence of medical devices].

    PubMed

    Ancellin, J

    1999-02-01

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

  14. 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.

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

    PubMed

    Levesque, Philippe; Sawan, Mohamad

    2009-08-01

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

  16. Inhibition of bacterial adhesion on medical devices.

    PubMed

    Rodrigues, Lígia R

    2011-01-01

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

  17. 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.

  18. 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.

  19. Application of Stereo-Imaging Technology to Medical Field

    PubMed Central

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

    2012-01-01

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

  20. [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

  1. Medical Device Recalls: Examination of Selected Cases

    DTIC Science & Technology

    1989-10-01

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

  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. Intrauterine contraceptive devices: MR imaging.

    PubMed

    Mark, A S; Hricak, H

    1987-02-01

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

  4. 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.

  5. 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.

  6. Medical imaging 4

    SciTech Connect

    Loew, M.H. )

    1990-01-01

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

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

    PubMed Central

    Hillman, B J

    1986-01-01

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

  8. 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...

  9. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  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, 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...

  12. Medical hyperspectral imaging: a review.

    PubMed

    Lu, Guolan; Fei, Baowei

    2014-01-01

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

  13. 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

  14. 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

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

    PubMed Central

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

    2010-01-01

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

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

    PubMed

    Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying

    2013-03-01

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

  17. 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

  18. 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... parts 1000 to 1050, subchapter J, to mean the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C... amending its authority citations in parts 1003, 1004, 1005, 1010, 1020, 1030, 1040, and 1050 to...

  19. [Membrane separation technology in medical devices].

    PubMed

    Hu, Xianghua; Dang, Xiyun; Wu, Minyu

    2014-01-01

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

  20. 77 FR 72924 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ..., pursuant to a written binding contract for the lease, installment sale, or sale on credit of a taxable... tax from sale price. Installment Sales, Leases, and Long-Term Contracts Several commenters requested transition relief for installment sales and leases of taxable medical devices where the contract is...

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

    PubMed

    Ma, Bozhi; Hao, Hongwei; Li, Luming

    2015-03-01

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

  2. 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

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

    PubMed

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

    2010-01-01

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

  4. 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.

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

    PubMed

    Tateishi, Minori; Tomizawa, Yasuko

    2009-01-01

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

  6. Fabricating a hybrid imaging device

    NASA Technical Reports Server (NTRS)

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

    2003-01-01

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

  7. Onboard tagging for smart medical devices.

    PubMed

    Li, Kejia; Warren, Steve

    2011-01-01

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

  8. Model observers in medical imaging research.

    PubMed

    He, Xin; Park, Subok

    2013-10-04

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

  9. 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

  10. Power Approaches for Implantable Medical Devices.

    PubMed

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

    2015-11-13

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

  11. Medical imaging: the radiation issue.

    PubMed

    Einstein, Andrew J

    2009-06-01

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

  12. 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

  13. Machine Learning for Medical Imaging.

    PubMed

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

    2017-01-01

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

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. [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.

  20. 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...

  1. 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

  2. Microscopy imaging device with advanced imaging properties

    DOEpatents

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

    2016-10-25

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

  3. Microscopy imaging device with advanced imaging properties

    DOEpatents

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

    2016-11-22

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

  4. Microscopy imaging device with advanced imaging properties

    DOEpatents

    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.

  5. Polyimide MEMS actuators for medical imaging

    NASA Astrophysics Data System (ADS)

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

    2005-01-01

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

  6. 78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... ``Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain... facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the IDE regulations. Early feasibility studies allow for limited early clinical evaluations of...

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

    PubMed

    Paul Segars, W; Tsui, Benjamin M W

    2009-12-01

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

  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. Medical imaging V

    SciTech Connect

    Loew, M.H.

    1991-01-01

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

  10. Medical Imaging Informatics.

    PubMed

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

    2016-01-01

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

  11. 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.

  12. 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.

  13. 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...

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

    PubMed

    Clarkson, Douglas M

    2017-03-01

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

  15. Teaching medical device design using design control.

    PubMed

    May-Newman, Karen; Cornwall, G Bryan

    2012-01-01

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

  16. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  17. 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... multilumen device with two balloons mounted near the distal tip. The proximal end has a multiport...

  18. Tracking medical devices to ensure patient safety.

    PubMed

    Beyea, Suzanne C

    2003-01-01

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

  19. 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.

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

    PubMed

    Kampfrath, Thomas; Cotten, Steven W

    2013-10-01

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

  1. 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.

  2. 75 FR 14170 - Medical Device Epidemiology Network: Developing Partnership Between the Center for Devices and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-24

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

  3. 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

  4. Resolution enhancement in medical ultrasound imaging.

    PubMed

    Ploquin, Marie; Basarab, Adrian; Kouamé, Denis

    2015-01-01

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

  5. 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.

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

    PubMed

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

    2013-01-01

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

  7. 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.

  8. 75 FR 16365 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 814 RIN 0910-AG29 Medical Devices; Pediatric... the regulations on premarket approval of medical devices to include requirements relating to the... submit certain medical device applications to include readily available information providing...

  9. 75 FR 16347 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... during our review, see Guidance for Industry and FDA Staff: Interactive Review for Medical Device... HUMAN SERVICES Food and Drug Administration 21 CFR Part 814 RIN 0910-AG29 Medical Devices; Pediatric... Administration (FDA) is amending the regulations on premarket approval of medical devices to include...

  10. 75 FR 875 - Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-06

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

  11. 77 FR 61768 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-11

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

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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

    ... 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: Notice... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

  17. 78 FR 20328 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

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

  18. 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

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

  19. 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...

  20. 76 FR 50485 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

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

  1. Calibration of imaging luminance measuring devices (ILMD)

    NASA Astrophysics Data System (ADS)

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

    2015-11-01

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

  2. 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.

  3. 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.

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

    PubMed

    Wang, Chenxi; Wang, Quan; Ren, Haiping

    2013-05-01

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

  5. Novel gaseous detectors for medical imaging

    NASA Astrophysics Data System (ADS)

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

    2004-02-01

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

  6. The value of diagnostic medical imaging.

    PubMed

    Bradley, Don; Bradley, Kendall E

    2014-01-01

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

  7. 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

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

    PubMed

    Raths, David

    2009-02-01

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

  9. 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.

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

    PubMed

    Sakuma, Ichiro

    2013-01-01

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

  11. Architectures and Devices for Millimeter Wave Imaging

    DTIC Science & Technology

    2009-02-01

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

  12. 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.

  13. 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

  14. 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.

  15. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  16. Processing of medical images using Maple

    NASA Astrophysics Data System (ADS)

    Toro Betancur, V.

    2013-05-01

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

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

    MedlinePlus

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

  18. 75 FR 41986 - Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

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

  19. 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...). The meeting will be open to the public. Name of Committee: Radiological Devices Panel of the Medical... committee hot line/ phone line to learn about possible modifications before coming to the meeting....

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

    PubMed

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

    2015-01-01

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

  1. 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

  2. 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.

  3. 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

  4. 31 CFR 561.327 - Food, medicine, and medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false Food, medicine, and medical devices... REGULATIONS General Definitions § 561.327 Food, medicine, and medical devices. (a) The term food means items...-grade gelatin powder, and peptones and their derivatives. (b) The term medicine has the same...

  5. 76 FR 7220 - Medical Device Innovation Initiative; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

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

  6. 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.

  7. 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.

  8. 77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

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

  10. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration... of the draft guidance entitled ``Medical Device Classification Product Codes.'' The purpose of the... classification product codes for medical devices regulated by the Center for Devices and Radiological...

  11. 77 FR 66847 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-07

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

  12. 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

  13. 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

  14. 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.

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

    PubMed

    Kirisits, Andreas; Redekop, W Ken

    2013-02-01

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

  16. 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.

  17. 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.

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

    PubMed

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

    2015-01-01

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

  19. 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.

  20. 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

  1. 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.

  2. A concept ideation framework for medical device design.

    PubMed

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

    2015-06-01

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

  3. 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.

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

    PubMed

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

    2011-01-01

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

  5. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  6. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  8. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

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

    PubMed

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

    2011-07-01

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

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

    PubMed

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

    2014-09-01

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

  11. 76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

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

  12. 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.

  13. 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.

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

    PubMed

    Großkopf, Volker; Jäkel, Christian

    2008-09-03

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

  15. Making Medical Devices Safer at Home

    MedlinePlus

    ... influence the caregiver's ability to use complex, high-maintenance devices. Usability is a critical factor in the ... with the start/stop button on an infusion pump or the inability to hear different types of ...

  16. Quality management for the processing of medical devices.

    PubMed

    Klosz, Kerstin

    2008-09-03

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

  17. 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration...

  18. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

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

  19. 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...

  20. 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...

  1. 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

    ... soluble salts or other drugs into the body for purposes other than those specified in part (a). Devices... HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION:...

  2. 76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology... for the filing and review of a petition for reclassification of such class III devices. In order to... effectiveness of the device for its intended use. After review of the information submitted in the petition,...

  3. 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...

  4. 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...

  5. 78 FR 55081 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

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

  6. 78 FR 67365 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

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

  7. 77 FR 16038 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

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

  8. 78 FR 49272 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

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

  9. 76 FR 56200 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-12

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

  10. 75 FR 7282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-18

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

  11. 76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

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

  12. 76 FR 63928 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

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

  13. 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

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

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

    PubMed

    Donawa, Maria

    2005-04-01

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

  16. 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.

  17. Laser focus compensating sensing and imaging device

    DOEpatents

    Vann, C.S.

    1993-08-31

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

  18. Laser focus compensating sensing and imaging device

    DOEpatents

    Vann, Charles S.

    1993-01-01

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

  19. The algorithm stitching for medical imaging

    NASA Astrophysics Data System (ADS)

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

    2016-05-01

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

  20. 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

  1. Content standards for medical image metadata

    NASA Astrophysics Data System (ADS)

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

    2003-12-01

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

  2. 76 FR 71982 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

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

  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. 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.

  5. 76 FR 24495 - Reprocessing of Reusable Medical Devices; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ... Medical Devices Workshop.'' The purpose of the workshop is to discuss factors affecting the reprocessing... devices with the overall goal to reduce the risk of infection. The topics to be discussed are: Factors... reprocessing may have been a contributing factor in microbial transmission and subsequent infection....

  6. [Microbiological diagnosis of medical device-associated infections].

    PubMed

    de Cueto-López, Marina; Del Pozo-León, Jose Luis; Franco-Álvarez de Luna, Francisco; Marin-Arriaza, Mercedes

    2016-12-01

    The use of surgically implanted medical devices has increased greatly over the last few years. Despite surgical advances and improvements in the materials and design of devices, infection continues to be a major complication of their use. Device-associated infections are produced mainly during their implantation and, are caused by microorganisms that are part of the skin flora. Biofilm development on device surfaces is the most important factor to explain the pathophysiological aspects of infection. Microbiological diagnosis is difficult and can often only be achieved after removal of the device. Sonication of the removed device may be a useful tool, since this procedure dislodges and disaggregates biofilm bacteria from the device. Molecular techniques, especially PCR, applied to the tissues and material obtained after sonication have shown to have a high sensitivity and specificity for the diagnosis of cardiovascular device infections.

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

    PubMed

    Dougherty, G

    2010-01-01

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

  8. 26 CFR 48.4191-2 - Taxable medical device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    .... Example 6. X manufactures pregnancy test kits. X sells the kits to distributors Y and Z, which, in turn, sell the pregnancy test kits to medical institutions and offices, medical professionals, and retail businesses. The FDA requires manufacturers of pregnancy test kits to list the kits as a device with the...

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

    PubMed

    Hyman, William A

    2010-06-01

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

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

    PubMed

    Larose, Emily

    2013-01-01

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

  11. Image-Capture Devices Extend Medicine's Reach

    NASA Technical Reports Server (NTRS)

    2009-01-01

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

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

    PubMed Central

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

    2009-01-01

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

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

    PubMed

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

    2009-01-01

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

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

    NASA Astrophysics Data System (ADS)

    Kock, M.; Lüllau, F.

    2012-03-01

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

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

    PubMed

    Cui, Hongen; Yao, Shaowei

    2015-03-01

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

  16. Medical imaging in new drug clinical development.

    PubMed

    Wang, Yi-Xiang; Deng, Min

    2010-12-01

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

  17. Denoising Medical Images using Calculus of Variations.

    PubMed

    Kohan, Mahdi Nakhaie; Behnam, Hamid

    2011-07-01

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

  18. 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.

  19. Medical image analysis with artificial neural networks.

    PubMed

    Jiang, J; Trundle, P; Ren, J

    2010-12-01

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

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

    PubMed

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

    2002-05-01

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

  1. Medical device integration using mobile telecommunications infrastructure.

    PubMed

    Moorman, Bridget A; Cockle, Richard A

    2013-01-01

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

  2. 4D Printing of Shape Memory-Based Personalized Endoluminal Medical Devices.

    PubMed

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

    2017-01-01

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

  3. 76 FR 34845 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

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

  4. [Image fusion in medical radiology].

    PubMed

    Burger, C

    1996-07-20

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

  5. Design Engineering of Biomaterials for Medical Devices

    NASA Astrophysics Data System (ADS)

    Hill, David

    1998-10-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  12. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  13. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

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

    PubMed

    Brewin, D; Leung, J; Easty, T

    2001-01-01

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

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

    PubMed

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

    2013-01-01

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

  16. Theory of Electron Imaging in Small Devices

    SciTech Connect

    Heller, Eric J.

    2015-05-21

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

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

    PubMed

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

    2010-01-01

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

  18. Image registration method for medical image sequences

    DOEpatents

    Gee, Timothy F.; Goddard, James S.

    2013-03-26

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

  19. Medical image libraries: ICoS project

    NASA Astrophysics Data System (ADS)

    Honniball, John; Thomas, Peter

    1999-08-01

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

  20. THz Medical Imaging: in vivo Hydration Sensing

    PubMed Central

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

    2015-01-01

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

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

    PubMed

    Galiano Riveros, Eduardo

    2002-12-01

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

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

    PubMed

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

    2016-05-01

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

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

    PubMed

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

    2010-01-01

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

  4. Aliphatic polyesters for medical imaging and theranostic applications.

    PubMed

    Nottelet, Benjamin; Darcos, Vincent; Coudane, Jean

    2015-11-01

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

  5. Advances in scintillators for medical imaging applications

    NASA Astrophysics Data System (ADS)

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

    2014-09-01

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

  6. Web-based medical image archive system

    NASA Astrophysics Data System (ADS)

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

    2002-05-01

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

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

    PubMed

    1998-11-12

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

  8. 76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-21

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

  9. 76 FR 36993 - Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 (formerly Docket No. 1997N-0484P) Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food...

  10. 75 FR 68972 - Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery..., 21 CFR part 878 is amended as follows: PART 878--GENERAL AND PLASTIC SURGERY DEVICES 0 1....

  11. 75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

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

  12. 78 FR 19717 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

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

  13. 75 FR 68200 - Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 892 Medical Devices; Radiology Devices... the Commissioner of Food and Drugs, 21 CFR part 892 is amended as follows: PART 892--RADIOLOGY...

  14. Image processing for medical diagnosis using CNN

    NASA Astrophysics Data System (ADS)

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

    2003-01-01

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

  15. Medical image segmentation by MDP model

    NASA Astrophysics Data System (ADS)

    Lu, Yisu; Chen, Wufan

    2011-11-01

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

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

    PubMed Central

    LI, WEIJIA; ZHOU, JING; XU, YUYIN

    2015-01-01

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

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

    PubMed

    Li, Weijia; Zhou, Jing; Xu, Yuyin

    2015-09-01

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

  18. Developing medical device software in compliance with regulations.

    PubMed

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

    2015-08-01

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

  19. Current perspectives in medical image perception

    PubMed Central

    Krupinski, Elizabeth A.

    2013-01-01

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

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

    PubMed

    Matsuoka, Atsuko

    2012-01-01

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

  1. A cloud-based medical image repository

    NASA Astrophysics Data System (ADS)

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

    2012-02-01

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

  2. Optical imaging device of retinal function

    NASA Astrophysics Data System (ADS)

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

    2002-06-01

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

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

    PubMed

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

    2016-06-01

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

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

    PubMed

    Hölscher, U M

    2014-12-01

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

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

    PubMed

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

    2009-03-01

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

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

    PubMed

    Casson, Alexander J; Rodriguez-Villegas, Esther

    2010-01-01

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

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

    PubMed

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

    2013-12-01

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

  8. Micro Computer Tomography for medical device and pharmaceutical packaging analysis.

    PubMed

    Hindelang, Florine; Zurbach, Raphael; Roggo, Yves

    2015-04-10

    Biomedical device and medicine product manufacturing are long processes facing global competition. As technology evolves with time, the level of quality, safety and reliability increases simultaneously. Micro Computer Tomography (Micro CT) is a tool allowing a deep investigation of products: it can contribute to quality improvement. This article presents the numerous applications of Micro CT for medical device and pharmaceutical packaging analysis. The samples investigated confirmed CT suitability for verification of integrity, measurements and defect detections in a non-destructive manner.

  9. Medical devices and procedures in the hyperbaric chamber.

    PubMed

    Kot, Jacek

    2014-12-01

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

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

    PubMed

    Koide, Akihiro

    2016-01-01

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

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

    PubMed

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

    2016-04-01

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

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

    PubMed

    Bachmor, T; Schöchlin, J; Bolz, A

    2002-01-01

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

  13. Robust Light Filters Support Powerful Imaging Devices

    NASA Technical Reports Server (NTRS)

    2009-01-01

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

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

    PubMed

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

    2009-01-01

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

  15. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Transitional pass-through payments: Medical devices...: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets the... under the criteria in paragraph (c) of this section. (b) Eligibility. A medical device must meet...

  16. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 3 2014-10-01 2014-10-01 false Transitional pass-through payments: Medical devices...: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets the... under the criteria in paragraph (c) of this section. (b) Eligibility. A medical device must meet...

  17. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Transitional pass-through payments: Medical devices...: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets the... under the criteria in paragraph (c) of this section. (b) Eligibility. A medical device must meet...

  18. Medical applications of microwave imaging.

    PubMed

    Wang, Zhao; Lim, Eng Gee; Tang, Yujun; Leach, Mark

    2014-01-01

    Ultrawide band (UWB) microwave imaging is a promising method for the detection of early stage breast cancer, based on the large contrast in electrical parameters between malignant tumour tissue and the surrounding normal breast-tissue. In this paper, the detection and imaging of a malignant tumour are performed through a tomographic based microwave system and signal processing. Simulations of the proposed system are performed and postimage processing is presented. Signal processing involves the extraction of tumour information from background information and then image reconstruction through the confocal method delay-and-sum algorithms. Ultimately, the revision of time-delay and the superposition of more tumour signals are applied to improve accuracy.

  19. Intuitionistic fuzzy segmentation of medical images.

    PubMed

    Chaira, Tamalika

    2010-06-01

    This paper proposes a novel and probably the first method, using Attanassov intuitionistic fuzzy set theory to segment blood vessels and also the blood cells in pathological images. This type of segmentation is very important in detecting different types of human diseases, e.g., an increase in the number of vessels may lead to cancer in prostates, mammary, etc. The medical images are not properly illuminated, and segmentation in that case becomes very difficult. A novel image segmentation approach using intuitionistic fuzzy set theory and a new membership function is proposed using restricted equivalence function from automorphisms, for finding the membership values of the pixels of the image. An intuitionistic fuzzy image is constructed using Sugeno type intuitionistic fuzzy generator. Local thresholding is applied to threshold medical images. The results showed a much better performance on poor contrast medical images, where almost all the blood vessels and blood cells are visible properly. There are several fuzzy and intuitionistic fuzzy thresholding methods, but these methods are not related to the medical images. To make a comparison with the proposed method with other thresholding methods, the method is compared with six nonfuzzy, fuzzy, and intuitionistic fuzzy methods.

  20. Automated medical image library creation for education.

    PubMed

    Smith, Mark; Feied, Craig; Gillam, Michael; Handler, Jonathan

    2006-01-01

    The authors describe a method to create a medical teaching library that is automatically maintained, contains tens of thousands of radiologic images and is built using existing, internal, hospital dictations, radiologic images, and an off-the-shelf commercial search engine product (Google Inc.).

  1. Acoustic waves in medical imaging and diagnostics.

    PubMed

    Sarvazyan, Armen P; Urban, Matthew W; Greenleaf, James F

    2013-07-01

    Up until about two decades ago acoustic imaging and ultrasound imaging were synonymous. The term ultrasonography, or its abbreviated version sonography, meant an imaging modality based on the use of ultrasonic compressional bulk waves. Beginning in the 1990s, there started to emerge numerous acoustic imaging modalities based on the use of a different mode of acoustic wave: shear waves. Imaging with these waves was shown to provide very useful and very different information about the biological tissue being examined. We discuss the physical basis for the differences between these two basic modes of acoustic waves used in medical imaging and analyze the advantages associated with shear acoustic imaging. A comprehensive analysis of the range of acoustic wavelengths, velocities and frequencies that have been used in different imaging applications is presented. We discuss the potential for future shear wave imaging applications.

  2. Multi-channel medical imaging system

    SciTech Connect

    Frangioni, John V

    2013-12-31

    A medical imaging system provides simultaneous rendering of visible light and fluorescent images. The system may employ dyes in a small-molecule form that remain in the subject's blood stream for several minutes, allowing real-time imaging of the subject's circulatory system superimposed upon a conventional, visible light image of the subject. The system may provide an excitation light source to excite the fluorescent substance and a visible light source for general illumination within the same optical guide used to capture images. The system may be configured for use in open surgical procedures by providing an operating area that is closed to ambient light. The systems described herein provide two or more diagnostic imaging channels for capture of multiple, concurrent diagnostic images and may be used where a visible light image may be usefully supplemented by two or more images that are independently marked for functional interest.

  3. Multi-channel medical imaging system

    SciTech Connect

    Frangioni, John V.

    2016-05-03

    A medical imaging system provides simultaneous rendering of visible light and fluorescent images. The system may employ dyes in a small-molecule form that remain in a subject's blood stream for several minutes, allowing real-time imaging of the subject's circulatory system superimposed upon a conventional, visible light image of the subject. The system may provide an excitation light source to excite the fluorescent substance and a visible light source for general illumination within the same optical guide used to capture images. The system may be configured for use in open surgical procedures by providing an operating area that is closed to ambient light. The systems described herein provide two or more diagnostic imaging channels for capture of multiple, concurrent diagnostic images and may be used where a visible light image may be usefully supplemented by two or more images that are independently marked for functional interest.

  4. Multispectral imaging for medical diagnosis

    NASA Technical Reports Server (NTRS)

    Anselmo, V. J.

    1977-01-01

    Photography technique determines amount of morbidity present in tissue. Imaging apparatus incorporates numerical filtering. Overall system operates in near-real time. Information gained from this system enables physician to understand extent of injury and leads to accelerated treatment.

  5. 76 FR 55394 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

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

  6. Medical Devices Assess, Treat Balance Disorders

    NASA Technical Reports Server (NTRS)

    2009-01-01

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

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

    PubMed

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

    2014-05-01

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

  8. Improved Interactive Medical-Imaging System

    NASA Technical Reports Server (NTRS)

    Ross, Muriel D.; Twombly, Ian A.; Senger, Steven

    2003-01-01

    An improved computational-simulation system for interactive medical imaging has been invented. The system displays high-resolution, three-dimensional-appearing images of anatomical objects based on data acquired by such techniques as computed tomography (CT) and magnetic-resonance imaging (MRI). The system enables users to manipulate the data to obtain a variety of views for example, to display cross sections in specified planes or to rotate images about specified axes. Relative to prior such systems, this system offers enhanced capabilities for synthesizing images of surgical cuts and for collaboration by users at multiple, remote computing sites.

  9. Medical imaging techniques: implications for nursing care.

    PubMed

    Malcolm, Alison

    The four basic techniques of medical imaging are X-ray, ultrasound, magnetic resonance and radionuclide. This article describes imaging techniques that display anatomical structure and those that are better at showing the physiological function of organs and tissues. Safety and preparation relating to nursing practice are discussed. Understanding the purpose and limitations of the different imaging techniques is important for providing best patient care.

  10. Development of wearable medical device for Bio-MEMS

    NASA Astrophysics Data System (ADS)

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

    2006-01-01

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

  11. Medical image segmentation using genetic algorithms.

    PubMed

    Maulik, Ujjwal

    2009-03-01

    Genetic algorithms (GAs) have been found to be effective in the domain of medical image segmentation, since the problem can often be mapped to one of search in a complex and multimodal landscape. The challenges in medical image segmentation arise due to poor image contrast and artifacts that result in missing or diffuse organ/tissue boundaries. The resulting search space is therefore often noisy with a multitude of local optima. Not only does the genetic algorithmic framework prove to be effective in coming out of local optima, it also brings considerable flexibility into the segmentation procedure. In this paper, an attempt has been made to review the major applications of GAs to the domain of medical image segmentation.

  12. Monte Carlo simulations of medical imaging modalities

    SciTech Connect

    Estes, G.P.

    1998-09-01

    Because continuous-energy Monte Carlo radiation transport calculations can be nearly exact simulations of physical reality (within data limitations, geometric approximations, transport algorithms, etc.), it follows that one should be able to closely approximate the results of many experiments from first-principles computations. This line of reasoning has led to various MCNP studies that involve simulations of medical imaging modalities and other visualization methods such as radiography, Anger camera, computerized tomography (CT) scans, and SABRINA particle track visualization. It is the intent of this paper to summarize some of these imaging simulations in the hope of stimulating further work, especially as computer power increases. Improved interpretation and prediction of medical images should ultimately lead to enhanced medical treatments. It is also reasonable to assume that such computations could be used to design new or more effective imaging instruments.

  13. Deep Learning in Medical Image Analysis.

    PubMed

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

    2017-03-09

    This review covers computer-assisted analysis of images in the field of medical imaging. Recent advances in machine learning, especially with regard to deep learning, are helping to identify, classify, and quantify patterns in medical images. At the core of these advances is the ability to exploit hierarchical feature representations learned solely from data, instead of features designed by hand according to domain-specific knowledge. Deep learning is rapidly becoming the state of the art, leading to enhanced performance in various medical applications. We introduce the fundamentals of deep learning methods and review their successes in image registration, detection of anatomical and cellular structures, tissue segmentation, computer-aided disease diagnosis and prognosis, and so on. We conclude by discussing research issues and suggesting future directions for further improvement. Expected final online publication date for the Annual Review of Biomedical Engineering Volume 19 is June 4, 2017. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

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

    PubMed

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

    2015-08-01

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

  15. 76 FR 48169 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-08

    ... Microbiology/ Medical Countermeasure Devices; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION... following public meeting: ``Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical... multiplexed microbiology/medical countermeasure (MCM) devices, their clinical application and public...

  16. Device for imaging scenes with very large ranges of intensity

    DOEpatents

    Deason, Vance Albert

    2011-11-15

    A device for imaging scenes with a very large range of intensity having a pair of polarizers, a primary lens, an attenuating mask, and an imaging device optically connected along an optical axis. Preferably, a secondary lens, positioned between the attenuating mask and the imaging device is used to focus light on the imaging device. The angle between the first polarization direction and the second polarization direction is adjustable.

  17. 78 FR 63225 - Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

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

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

    PubMed

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

    2013-01-01

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

  19. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine....515 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of...

  20. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of...

  1. Lessons learned: mobile device encryption in the academic medical center.

    PubMed

    Kusche, Kristopher P

    2009-01-01

    The academic medical center is faced with the unique challenge of meeting the multi-faceted needs of both a modern healthcare organization and an academic institution, The need for security to protect patient information must be balanced by the academic freedoms expected in the college setting. The Albany Medical Center, consisting of the Albany Medical College and the Albany Medical Center Hospital, was challenged with implementing a solution that would preserve the availability, integrity and confidentiality of business, patient and research data stored on mobile devices. To solve this problem, Albany Medical Center implemented a mobile encryption suite across the enterprise. Such an implementation comes with complexities, from performance across multiple generations of computers and operating systems, to diversity of application use mode and end user adoption, all of which requires thoughtful policy and standards creation, understanding of regulations, and a willingness and ability to work through such diverse needs.

  2. Perinatal Staff Nurse Medical Device Use and Education.

    ERIC Educational Resources Information Center

    McConnell, Edwina A.

    1998-01-01

    Survey responses from 48 perinatal nurses found that most learned about medical devices by reading manuals; 75% had received inservice training; and 95% learned from other staff. Inadequate knowledge was related to fear of causing patient harm. Initial learning method influenced what was learned, and hands-on experience was considered efficacious.…

  3. From concept to exit strategies--medical device innovation.

    PubMed

    Kermit, Eben L

    2004-01-01

    It's quite a rollercoaster ride when you are part of a medical device start-up team. There are often many partners and processes that are not often taught in school or in the training to do research . For example, how does one obtain financing, protect intellectual property, set up a business, work with contract designers and/or manufacturers? Bringing a medical device business into existence is challenging and generally, only one in 10 medical device start ups make it. This lively 2-hour session brings together panelists with many years of start-up experience to give the audience a perspective of the many facets and ways to successfully (and sometimes not so successfully) bring a product to market. This is a panel discussion on the "nuts and bolts" of medical device innovation, how to do it, what to watch out for, a sharing of experience and lessons learned. The panelists include: Amir Belson M. D.--Neoguide Systems Thomas Conn--consultant Tom Goff, Kerberos MD; Eric Goldfarb--Evalve Sorin Grunwald, Ph.D./MBA--BC Tech Nicole Walker--Onset Ventures D.J. Williams, PhD--Loughborough University.

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

    PubMed

    Parsons, M S

    1998-01-01

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

  5. A patient-centric distribution architecture for medical image sharing.

    PubMed

    Constantinescu, Liviu; Kim, Jinman; Kumar, Ashnil; Haraguchi, Daiki; Wen, Lingfeng; Feng, Dagan

    2013-01-01

    Over the past decade, rapid development of imaging technologies has resulted in the introduction of improved imaging devices, such as multi-modality scanners that produce combined positron emission tomography-computed tomography (PET-CT) images. The adoption of picture archiving and communication systems (PACS) in hospitals have dramatically improved the ability to digitally share medical image studies via portable storage, mobile devices and the Internet. This has in turn led to increased productivity, greater flexibility, and improved communication between hospital staff, referring physicians, and outpatients. However, many of these sharing and viewing capabilities are limited to proprietary vendor-specific applications. Furthermore, there are still interoperability and deployment issues which reduce the rate of adoption of such technologies, thus leaving many stakeholders, particularly outpatients and referring physicians, with access to only traditional still images with no ability to view or interpret the data in full. In this paper, we present a distribution architecture for medical image display across numerous devices and media, which uses a preprocessor and an in-built networking framework to improve compatibility and promote greater accessibility of medical data. Our INVOLVE2 system consists of three main software modules: 1) a preprocessor, which collates and converts imaging studies into a compressed and distributable format; 2) a PACS-compatible workflow for self-managing distribution of medical data, e.g. via CD USB, network etc; 3) support for potential mobile and web-based data access. The focus of this study was on cultivating patient-centric care, by allowing outpatient users to comfortably access and interpret their own data. As such, the image viewing software included on our cross-platform CDs was designed with a simple and intuitive user-interface (UI) for use by outpatients and referring physicians. Furthermore, digital image access via

  6. Imaging requirements for medical applications of additive manufacturing.

    PubMed

    Huotilainen, Eero; Paloheimo, Markku; Salmi, Mika; Paloheimo, Kaija-Stiina; Björkstrand, Roy; Tuomi, Jukka; Markkola, Antti; Mäkitie, Antti

    2014-02-01

    Additive manufacturing (AM), formerly known as rapid prototyping, is steadily shifting its focus from industrial prototyping to medical applications as AM processes, bioadaptive materials, and medical imaging technologies develop, and the benefits of the techniques gain wider knowledge among clinicians. This article gives an overview of the main requirements for medical imaging affected by needs of AM, as well as provides a brief literature review from existing clinical cases concentrating especially on the kind of radiology they required. As an example application, a pair of CT images of the facial skull base was turned into 3D models in order to illustrate the significance of suitable imaging parameters. Additionally, the model was printed into a preoperative medical model with a popular AM device. Successful clinical cases of AM are recognized to rely heavily on efficient collaboration between various disciplines - notably operating surgeons, radiologists, and engineers. The single main requirement separating tangible model creation from traditional imaging objectives such as diagnostics and preoperative planning is the increased need for anatomical accuracy in all three spatial dimensions, but depending on the application, other specific requirements may be present as well. This article essentially intends to narrow the potential communication gap between radiologists and engineers who work with projects involving AM by showcasing the overlap between the two disciplines.

  7. Clinical research challenges in the era of cardiovascular medical devices

    PubMed Central

    2016-01-01

    New therapeutic alternatives, such as innovative medical devices, are frequently the only treatment options left for patients when other efficient medical modalities are lacking or insufficient. Development of novel devices, which are safe and effective, requires understanding of complex premarket and postmarket provisions, including characteristics of clinical trials. Speeding up patient access to new technologies may imply the need to make choices in terms of extent and robustness of clinical evaluation without losing the patient safety perspective. In such situations, some challenges can readily arise due to existing methodological solutions and aspects of current legislation in the field. In this context, some challenges, occurring at various stages of the device lifecycle, will be presented in order to observe the changes and hopefully to contribute to better knowledge and improvements in the area. PMID:27785138

  8. Missing data in the regulation of medical devices.

    PubMed

    Campbell, Gregory; Pennello, Gene; Yue, Lilly

    2011-03-01

    Handling missing data is an important consideration in the analysis of data from all kinds of medical device studies. Missing data in medical device studies can arise for all the reasons one might expect in pharmaceutical clinical trials. In addition, they occur by design, in nonrandomized device studies, and in evaluations of diagnostic tests. For dichotomous endpoints, a tipping point analysis can be used to examine nonparametrically the sensitivity of conclusions to missing data. In general, sensitivity analysis is an important tool to study deviations from simple assumptions about missing data, such as the data being missing at random. Approaches to missing data in Bayesian trials are discussed, including sensitivity analysis. Many types of missing data that can occur with diagnostic test evaluations are surveyed. Careful planning and conduct are recommended to minimize missing data. Although difficult, the prespecification of all missing data analysis strategies is encouraged before any data are collected.

  9. Medical Device Risk Management For Performance Assurance Optimization and Prioritization.

    PubMed

    Gaamangwe, Tidimogo; Babbar, Vishvek; Krivoy, Agustina; Moore, Michael; Kresta, Petr

    2015-01-01

    Performance assurance (PA) is an integral component of clinical engineering medical device risk management. For that reason, the clinical engineering (CE) community has made concerted efforts to define appropriate risk factors and develop quantitative risk models for efficient data processing and improved PA program operational decision making. However, a common framework that relates the various processes of a quantitative risk system does not exist. This article provides a perspective that focuses on medical device quality and risk-based elements of the PA program, which include device inclusion/exclusion, schedule optimization, and inspection prioritization. A PA risk management framework is provided, and previous quantitative models that have contributed to the advancement of PA risk management are examined. A general model for quantitative risk systems is proposed, and further perspective on possible future directions in the area of PA technology is also provided.

  10. Perspectives of medical X-ray imaging

    NASA Astrophysics Data System (ADS)

    Freudenberger, J.; Hell, E.; Knüpfer, W.

    2001-06-01

    While X-ray image intensifiers (XII), storage phosphor screens and film-screen systems are still the work horses of medical imaging, large flat panel solid state detectors using either scintillators and amorphous silicon photo diode arrays (FD-Si), or direct X-ray conversion in amorphous selenium are reaching maturity. The main advantage with respect to image quality and low patient dose of the XII and FD-Si systems is caused by the rise of the Detector Quantum Efficiency originating from the application of thick needle-structured phosphor X-ray absorbers. With the detectors getting closer to an optimal state, further progress in medical X-ray imaging requires an improvement of the usable source characteristics. The development of clinical monochromatic X-ray sources of high power would not only allow an improved contrast-to-dose ratio by allowing smaller average photon energies in applications but would also lead to new imaging techniques.

  11. Nanotechnology-supported THz medical imaging

    PubMed Central

    Stylianou, Andreas; Talias, Michael A

    2013-01-01

    Over the last few decades, the achievements and progress in the field of medical imaging have dramatically enhanced the early detection and treatment of many pathological conditions. The development of new imaging modalities, especially non-ionising ones, which will improve prognosis, is of crucial importance. A number of novel imaging modalities have been developed but they are still in the initial stages of development and serious drawbacks obstruct them from offering their benefits to the medical field. In the 21 st century, it is believed that nanotechnology will highly influence our everyday life and dramatically change the world of medicine, including medical imaging. Here we discuss how nanotechnology, which is still in its infancy, can improve Terahertz (THz) imaging, an emerging imaging modality, and how it may find its way into real clinical applications. THz imaging is characterised by the use of non-ionising radiation and although it has the potential to be used in many biomedical fields, it remains in the field of basic research. An extensive review of the recent available literature shows how the current state of this emerging imaging modality can be transformed by nanotechnology. Innovative scientific concepts that use nanotechnology-based techniques to overcome some of the limitations of the use of THz imaging are discussed. We review a number of drawbacks, such as a low contrast mechanism, poor source performance and bulky THz systems, which characterise present THz medical imaging and suggest how they can be overcome through nanotechnology. Better resolution and higher detection sensitivity can also be achieved using nanotechnology techniques. PMID:24555052

  12. Multiscale Medical Image Fusion in Wavelet Domain

    PubMed Central

    Khare, Ashish

    2013-01-01

    Wavelet transforms have emerged as a powerful tool in image fusion. However, the study and analysis of medical image fusion is still a challenging area of research. Therefore, in this paper, we propose a multiscale fusion of multimodal medical images in wavelet domain. Fusion of medical images has been performed at multiple scales varying from minimum to maximum level using maximum selection rule which provides more flexibility and choice to select the relevant fused images. The experimental analysis of the proposed method has been performed with several sets of medical images. Fusion results have been evaluated subjectively and objectively with existing state-of-the-art fusion methods which include several pyramid- and wavelet-transform-based fusion methods and principal component analysis (PCA) fusion method. The comparative analysis of the fusion results has been performed with edge strength (Q), mutual information (MI), entropy (E), standard deviation (SD), blind structural similarity index metric (BSSIM), spatial frequency (SF), and average gradient (AG) metrics. The combined subjective and objective evaluations of the proposed fusion method at multiple scales showed the effectiveness and goodness of the proposed approach. PMID:24453868

  13. French Sizing of Medical Devices is not Fit for Purpose

    SciTech Connect

    Kibriya, Nabil Hall, Rebecca; Powell, Steven; How, Thien; McWilliams, Richard G.

    2013-08-01

    PurposeThe purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology.MethodsThe labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.ResultsA total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm.The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.ConclusionsOur results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed.

  14. Quantitative imaging features: extension of the oncology medical image database

    NASA Astrophysics Data System (ADS)

    Patel, M. N.; Looney, P. T.; Young, K. C.; Halling-Brown, M. D.

    2015-03-01

    Radiological imaging is fundamental within the healthcare industry and has become routinely adopted for diagnosis, disease monitoring and treatment planning. With the advent of digital imaging modalities and the rapid growth in both diagnostic and therapeutic imaging, the ability to be able to harness this large influx of data is of paramount importance. The Oncology Medical Image Database (OMI-DB) was created to provide a centralized, fully annotated dataset for research. The database contains both processed and unprocessed images, associated data, and annotations and where applicable expert determined ground truths describing features of interest. Medical imaging provides the ability to detect and localize many changes that are important to determine whether a disease is present or a therapy is effective by depicting alterations in anatomic, physiologic, biochemical or molecular processes. Quantitative imaging features are sensitive, specific, accurate and reproducible imaging measures of these changes. Here, we describe an extension to the OMI-DB whereby a range of imaging features and descriptors are pre-calculated using a high throughput approach. The ability to calculate multiple imaging features and data from the acquired images would be valuable and facilitate further research applications investigating detection, prognosis, and classification. The resultant data store contains more than 10 million quantitative features as well as features derived from CAD predictions. Theses data can be used to build predictive models to aid image classification, treatment response assessment as well as to identify prognostic imaging biomarkers.

  15. SMPTE Test Pattern For Certification Of Medical Diagnostic Display Devices

    NASA Astrophysics Data System (ADS)

    Lisk, Kenneth G.

    1984-08-01

    Since the invention of x-rays by Wilhelm Conrad Roentgen, rapid advances have been made in the radiological detection of body abnormalities. This was very evident in the 1960's and 70's when the marriage of computers to radiology gave birth to a new generation of imaging modalities such as computerized tomography, ultrasound, digital radiographic imaging, nuclear medicine, and nuclear magnetic resonance. Many of these devices employ digital computer techniques for signal manipulation, and the resultant analog diagnostic images are displayed on television monitors for viewing and on imaging cathode-ray tubes for a photographic hard copy.

  16. Supervised restoration of degraded medical images using multiple-point geostatistics.

    PubMed

    Pham, Tuan D

    2012-06-01

    Reducing noise in medical images has been an important issue of research and development for medical diagnosis, patient treatment, and validation of biomedical hypotheses. Noise inherently exists in medical and biological images due to the acquisition and transmission in any imaging devices. Being different from image enhancement, the purpose of image restoration is the process of removing noise from a degraded image in order to recover as much as possible its original version. This paper presents a statistically supervised approach for medical image restoration using the concept of multiple-point geostatistics. Experimental results have shown the effectiveness of the proposed technique which has potential as a new methodology for medical and biological image processing.

  17. A hybrid technique for medical image segmentation.

    PubMed

    Nyma, Alamgir; Kang, Myeongsu; Kwon, Yung-Keun; Kim, Cheol-Hong; Kim, Jong-Myon

    2012-01-01

    Medical image segmentation is an essential and challenging aspect in computer-aided diagnosis and also in pattern recognition research. This paper proposes a hybrid method for magnetic resonance (MR) image segmentation. We first remove impulsive noise inherent in MR images by utilizing a vector median filter. Subsequently, Otsu thresholding is used as an initial coarse segmentation method that finds the homogeneous regions of the input image. Finally, an enhanced suppressed fuzzy c-means is used to partition brain MR images into multiple segments, which employs an optimal suppression factor for the perfect clustering in the given data set. To evaluate the robustness of the proposed approach in noisy environment, we add different types of noise and different amount of noise to T1-weighted brain MR images. Experimental results show that the proposed algorithm outperforms other FCM based algorithms in terms of segmentation accuracy for both noise-free and noise-inserted MR images.

  18. Medical image registration using fuzzy theory.

    PubMed

    Pan, Meisen; Tang, Jingtian; Xiong, Qi

    2012-01-01

    Mutual information (MI)-based registration, which uses MI as the similarity measure, is a representative method in medical image registration. It has an excellent robustness and accuracy, but with the disadvantages of a large amount of calculation and a long processing time. In this paper, by computing the medical image moments, the centroid is acquired. By applying fuzzy c-means clustering, the coordinates of the medical image are divided into two clusters to fit a straight line, and the rotation angles of the reference and floating images are computed, respectively. Thereby, the initial values for registering the images are determined. When searching the optimal geometric transformation parameters, we put forward the two new concepts of fuzzy distance and fuzzy signal-to-noise ratio (FSNR), and we select FSNR as the similarity measure between the reference and floating images. In the experiments, the Simplex method is chosen as multi-parameter optimisation. The experimental results show that this proposed method has a simple implementation, a low computational cost, a fast registration and good registration accuracy. Moreover, it can effectively avoid trapping into the local optima. It is adapted to both mono-modality and multi-modality image registrations.

  19. Tracking and surveillance of patients with medical devices and implants.

    PubMed

    Morgan, R W

    1993-01-01

    The United States Congress and FDA recently proposed modifications to the regulation for the tracking of certain medical devices and implants that will place significant demands on the manufacturers and importers of those products. The regulation, which comes into effect in August this year, will require the industry to carry out not only tracking of those devices or implants to the end user, but also continued observation of the device user or implant recipient throughout the life of the patient or the device. In this article, the author outlines FDA requirements and advises how best to meet those demands. The important elements for setting up a patient-tracking programme are discussed; these include the use of a Patient Registry as a basis for tracking and the importance of confidentiality throughout the tracking process.

  20. Feasibility of energy harvesting techniques for wearable medical devices.

    PubMed

    Voss, Thaddaeus J; Subbian, Vignesh; Beyette, Fred R

    2014-01-01

    Wearable devices are arguably one of the most rapidly growing technologies in the computing and health care industry. These systems provide improved means of monitoring health status of humans in real-time. In order to cope with continuous sensing and transmission of biological and health status data, it is desirable to move towards energy autonomous systems that can charge batteries using passive, ambient energy. This not only ensures uninterrupted data capturing, but could also eliminate the need to frequently remove, replace, and recharge batteries. To this end, energy harvesting is a promising area that can lead to extremely power-efficient portable medical devices. This paper presents an experimental prototype to study the feasibility of harvesting two energy sources, solar and thermoelectric energy, in the context of wearable devices. Preliminary results show that such devices can be powered by transducing ambient energy that constantly surrounds us.

  1. A new concept for medical imaging centered on cellular phone technology.

    PubMed

    Granot, Yair; Ivorra, Antoni; Rubinsky, Boris

    2008-04-30

    According to World Health Organization reports, some three quarters of the world population does not have access to medical imaging. In addition, in developing countries over 50% of medical equipment that is available is not being used because it is too sophisticated or in disrepair or because the health personnel are not trained to use it. The goal of this study is to introduce and demonstrate the feasibility of a new concept in medical imaging that is centered on cellular phone technology and which may provide a solution to medical imaging in underserved areas. The new system replaces the conventional stand-alone medical imaging device with a new medical imaging system made of two independent components connected through cellular phone technology. The independent units are: a) a data acquisition device (DAD) at a remote patient site that is simple, with limited controls and no image display capability and b) an advanced image reconstruction and hardware control multiserver unit at a central site. The cellular phone technology transmits unprocessed raw data from the patient site DAD and receives and displays the processed image from the central site. (This is different from conventional telemedicine where the image reconstruction and control is at the patient site and telecommunication is used to transmit processed images from the patient site). The primary goal of this study is to demonstrate that the cellular phone technology can function in the proposed mode. The feasibility of the concept is demonstrated using a new frequency division multiplexing electrical impedance tomography system, which we have developed for dynamic medical imaging, as the medical imaging modality. The system is used to image through a cellular phone a simulation of breast cancer tumors in a medical imaging diagnostic mode and to image minimally invasive tissue ablation with irreversible electroporation in a medical imaging interventional mode.

  2. Microwave impedance imaging on semiconductor memory devices

    NASA Astrophysics Data System (ADS)

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

    2011-03-01

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

  3. Wearable Devices in Medical Internet of Things: Scientific Research and Commercially Available Devices

    PubMed Central

    Thurow, Kerstin; Stoll, Regina

    2017-01-01

    Objectives Wearable devices are currently at the heart of just about every discussion related to the Internet of Things. The requirement for self-health monitoring and preventive medicine is increasing due to the projected dramatic increase in the number of elderly people until 2020. Developed technologies are truly able to reduce the overall costs for prevention and monitoring. This is possible by constantly monitoring health indicators in various areas, and in particular, wearable devices are considered to carry this task out. These wearable devices and mobile apps now have been integrated with telemedicine and telehealth efficiently, to structure the medical Internet of Things. This paper reviews wearable health care devices both in scientific papers and commercial efforts. Methods MIoT is demonstrated through a defined architecture design, including hardware and software dealing with wearable devices, sensors, smart phones, medical application, and medical station analyzers for further diagnosis and data storage. Results Wearables, with the help of improved technology have been developed greatly and are considered reliable tools for long-term health monitoring systems. These are applied in the observation of a large variety of health monitoring indicators in the environment, vital signs, and fitness. Conclusions Wearable devices are now used for a wide range of healthcare observation. One of the most important elements essential in data collection is the sensor. During recent years with improvement in semiconductor technology, sensors have made investigation of a full range of parameters closer to realization. PMID:28261526

  4. 21 CFR 801.150 - Medical devices; processing, labeling, or repacking.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; processing, labeling, or... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Other Exemptions § 801.150 Medical devices... shipment or other delivery of a device which is, in accordance with the practice of the trade, to...

  5. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  6. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device... reactivity of the human blood or blood component in the medical device presents no significant health...

  7. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; prominence of required label... SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices... information, resulting from the use of label space for any word, statement, design, or device which is...

  8. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  9. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device... reactivity of the human blood or blood component in the medical device presents no significant health...

  10. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device... reactivity of the human blood or blood component in the medical device presents no significant health...

  11. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 3 2011-10-01 2011-10-01 false Transitional pass-through payments: Medical devices... devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets the... under the criteria in paragraph (c) of this section. (b) Eligibility. A medical device must meet...

  12. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device... reactivity of the human blood or blood component in the medical device presents no significant health...

  13. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device... reactivity of the human blood or blood component in the medical device presents no significant health...

  14. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  15. 21 CFR 801.150 - Medical devices; processing, labeling, or repacking.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; processing, labeling, or... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Other Exemptions § 801.150 Medical devices... shipment or other delivery of a device which is, in accordance with the practice of the trade, to...

  16. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; prominence of required label... SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices... information, resulting from the use of label space for any word, statement, design, or device which is...

  17. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  18. 21 CFR 801.150 - Medical devices; processing, labeling, or repacking.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; processing, labeling, or... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Other Exemptions § 801.150 Medical devices... shipment or other delivery of a device which is, in accordance with the practice of the trade, to...

  19. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  20. 78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... HUMAN SERVICES Food and Drug Administration Medical Device Classification Product Codes; Guidance for... guidance entitled ``Medical Device Classification Product Codes.'' This document describes how device product codes are used in a variety of FDA program areas to regulate and track medical devices...

  1. Adaptive MOEMS mirrors for medical imaging

    NASA Astrophysics Data System (ADS)

    Fayek, Reda; Ibrahim, Hany

    2007-03-01

    This paper presents micro-electro-mechanical-systems (MEMS) optical elements with high angular deflection arranged in arrays to perform dynamic laser beam focusing and scanning. Each element selectively addresses a portion of the laser beam. These devices are useful in medical and research applications including laser-scanning microscopy, confocal microscopes, and laser capture micro-dissection. Such laser-based imaging and diagnostic instruments involve complex laser beam manipulations. These often require compound lenses and mirrors that introduce misalignment, attenuation, distortion and light scatter. Instead of using expensive spherical and aspherical lenses and/or mirrors for sophisticated laser beam manipulations, we propose scalable adaptive micro-opto-electro-mechanical-systems (MOEMS) arrays to recapture optical performance and compensate for aberrations, distortions and imperfections introduced by inexpensive optics. A high-density array of small, individually addressable, MOEMS elements is similar to a Fresnel mirror. A scalable 2D array of micro-mirrors approximates spherical or arbitrary surface mirrors of different apertures. A proof of concept prototype was built using PolyMUMP TM due to its reliability, low cost and limited post processing requirements. Low-density arrays (2x2 arrays of square elements, 250x250μm each) were designed, fabricated, and tested. Electrostatic comb fingers actuate the edges of the square mirrors with a low actuation voltage of 20 V - 50 V. CoventorWare TM was used for the design, 3D modeling and motion simulations. Initial results are encouraging. The array is adaptive, configurable and scalable with low actuation voltage and a large tuning range. Individual element addressability would allow versatile uses. Future research will increase deflection angles and maximize reflective area.

  2. MRIdb: medical image management for biobank research.

    PubMed

    Woodbridge, Mark; Fagiolo, Gianlorenzo; O'Regan, Declan P

    2013-10-01

    Clinical picture archiving and communications systems provide convenient, efficient access to digital medical images from multiple modalities but can prove challenging to deploy, configure and use. MRIdb is a self-contained image database, particularly suited to the storage and management of magnetic resonance imaging data sets for population phenotyping. It integrates a mature image archival system with an intuitive web-based user interface that provides visualisation and export functionality. In addition, utilities for auditing, data migration and system monitoring are included in a virtual machine image that is easily deployed with minimal configuration. The result is a freely available turnkey solution, designed to support epidemiological and imaging genetics research. It allows the management of patient data sets in a secure, scalable manner without requiring the installation of any bespoke software on end users' workstations. MRIdb is an open-source software, available for download at http://www3.imperial.ac.uk/bioinfsupport/resources/software/mridb .

  3. Management information system of medical equipment using mobile devices

    NASA Astrophysics Data System (ADS)

    Núñez, C.; Castro, D.

    2011-09-01

    The large numbers of technologies currently incorporated into mobile devices transform them into excellent tools for capture and to manage the information, because of the increasing computing power and storage that allow to add many miscellaneous applications. In order to obtain benefits of these technologies, in the biomedical engineering field, it was developed a mobile information system for medical equipment management. The central platform for the system it's a mobile phone, which by a connection with a web server, it's capable to send and receive information relative to any medical equipment. Decoding a type of barcodes, known as QR-Codes, the management process is simplified and improved. These barcodes identified the medical equipments in a database, when these codes are photographed and decoded with the mobile device, you can access to relevant information about the medical equipment in question. This Project in it's actual state is a basic support tool for the maintenance of medical equipment. It is also a modern alternative, competitive and economic in the actual market.

  4. Tunable Ultrasonic Energy Harvesting for Implantable Biosensors and Medical Devices

    NASA Astrophysics Data System (ADS)

    Pellegrino, M.; Eovino, B. E.; Beker, L.; Bourouina, T.; Lin, L.

    2016-11-01

    This work reports a tunable ultrasonic energy harvesting (UEH) device capable of high power output and/or large bandwidth based on concentric piezoelectric ring-shaped structures. Two different designs are presented: (1) the single ring-shaped UEH (r-UEH), and (2) concentric r-UEHs. Concentric r-UEHs can save space and therefore can provide benefits in powering low-power implantable biosensors and medical devices. This paper presents results of simulation studies and initial experiments of a single r-UEH.

  5. Career development of biomedical engineers in medical device industry.

    PubMed

    Ni, Quan; Pu, Yachuan

    2009-01-01

    With concerns of the current health care system, biomedical engineers have expertise, opportunity and responsibility in developing innovations that may improve cost, coverage and quality of health care delivery. This paper reviews the product development process in the medical device industry, and the associated training and experience required for biomedical engineers involved at each stage of the process. This paper also provides personal perspectives of some of the differences between established device companies and start-ups in the product development process and career paths for biomedical engineers.

  6. Elastomeric actuator devices for magnetic resonance imaging

    NASA Technical Reports Server (NTRS)

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

    2008-01-01

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

  7. Modeling and Imaging Flexural Plate Wave Devices

    SciTech Connect

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

    1999-07-09

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

  8. A medical application integrating remote 3D visualization tools to access picture archiving and communication system on mobile devices.

    PubMed

    He, Longjun; Ming, Xing; Liu, Qian

    2014-04-01

    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. However, for direct interactive 3D visualization, which plays an important role in radiological diagnosis, the mobile device cannot provide a satisfactory quality of experience for radiologists. This paper developed a medical system that can get medical images from the picture archiving and communication system on the mobile device over the wireless network. In the proposed application, the mobile device got patient information and medical images through a proxy server connecting to the PACS server. Meanwhile, the proxy server integrated a range of 3D visualization techniques, including maximum intensity projection, multi-planar reconstruction and direct volume rendering, to providing shape, brightness, depth and location information generated from the original sectional images for radiologists. Furthermore, an algorithm that changes remote render parameters automatically to adapt to the network status was employed to improve the quality of experience. Finally, performance issues regarding the remote 3D visualization of the medical images over the wireless network of the proposed application were also discussed. The results demonstrated that this proposed medical application could provide a smooth interactive experience in the WLAN and 3G networks.

  9. The Imaging and Medical Beam Line at the Australian Synchrotron

    NASA Astrophysics Data System (ADS)

    Hausermann, Daniel; Hall, Chris; Maksimenko, Anton; Campbell, Colin

    2010-07-01

    As a result of the enthusiastic support from the Australian biomedical, medical and clinical communities, the Australian Synchrotron is constructing a world-class facility for medical research, the `Imaging and Medical Beamline'. The IMBL began phased commissioning in late 2008 and is scheduled to commence the first clinical research programs with patients in 2011. It will provide unrivalled x-ray facilities for imaging and radiotherapy for a wide range of research applications in diseases, treatments and understanding of physiological processes. The main clinical research drivers are currently high resolution and sensitivity cardiac and breast imaging, cell tracking applied to regenerative and stem cell medicine and cancer therapies. The beam line has a maximum source to sample distance of 136 m and will deliver a 60 cm by 4 cm x-ray beam1—monochromatic and white—to a three storey satellite building fully equipped for pre-clinical and clinical research. Currently operating with a 1.4 Tesla multi-pole wiggler, it will upgrade to a 4.2 Tesla device which requires the ability to handle up to 21 kW of x-ray power at any point along the beam line. The applications envisaged for this facility include imaging thick objects encompassing materials, humans and animals. Imaging can be performed in the range 15-150 keV. Radiotherapy research typically requires energies between 30 and 120 keV, for both monochromatic and broad beam.

  10. [Promoting "well-treatment" in medical imaging].

    PubMed

    Renouf, Nicole; Llop, Marc

    2012-12-01

    A project to promote "well-treatment" has been initiated in the medical imaging department of a Parisian hospital. With the aim of promoting the well-being of the patient and developing shared values of empathy and respect, the members of this medico-technical team have undertaken to build a culture of "well-treatment" which respects the patient's dignity and rights.

  11. Medical Imaging with Ultrasound: Some Basic Physics.

    ERIC Educational Resources Information Center

    Gosling, R.

    1989-01-01

    Discussed are medical applications of ultrasound. The physics of the wave nature of ultrasound including its propagation and production, return by the body, spatial and contrast resolution, attenuation, image formation using pulsed echo ultrasound techniques, measurement of velocity and duplex scanning are described. (YP)

  12. Heparin coatings for improving blood compatibility of medical devices.

    PubMed

    Biran, Roy; Pond, Daniel

    2016-12-29

    Blood contact with biomaterials triggers activation of multiple reactive mechanisms that can impair the performance of implantable medical devices and potentially cause serious adverse clinical events. This includes thrombosis and thromboembolic complications due to activation of platelets and the coagulation cascade, activation of the complement system, and inflammation. Numerous surface coatings have been developed to improve blood compatibility of biomaterials. For more than thirty years, the anticoagulant drug heparin has been employed as a covalently immobilized surface coating on a variety of medical devices. This review describes the fundamental principles of non-eluting heparin coatings, mechanisms of action, and clinical applications with focus on those technologies which have been commercialized. Because of its extensive publication history, there is emphasis on the CARMEDA(®) BioActive Surface (CBAS(®) Heparin Surface), a widely used commercialized technology for the covalent bonding of heparin.

  13. Towards automated assistance for operating home medical devices.

    PubMed

    Gao, Zan; Detyniecki, Marcin; Chen, Ming-Yu; Wu, Wen; Hauptmann, Alexander G; Wactlar, Howard D

    2010-01-01

    To detect errors when subjects operate a home medical device, we observe them with multiple cameras. We then perform action recognition with a robust approach to recognize action information based on explicitly encoding motion information. This algorithm detects interest points and encodes not only their local appearance but also explicitly models local motion. Our goal is to recognize individual human actions in the operations of a home medical device to see if the patient has correctly performed the required actions in the prescribed sequence. Using a specific infusion pump as a test case, requiring 22 operation steps from 6 action classes, our best classifier selects high likelihood action estimates from 4 available cameras, to obtain an average class recognition rate of 69%.

  14. Medical image registration using sparse coding of image patches.

    PubMed

    Afzali, Maryam; Ghaffari, Aboozar; Fatemizadeh, Emad; Soltanian-Zadeh, Hamid

    2016-06-01

    Image registration is a basic task in medical image processing applications like group analysis and atlas construction. Similarity measure is a critical ingredient of image registration. Intensity distortion of medical images is not considered in most previous similarity measures. Therefore, in the presence of bias field distortions, they do not generate an acceptable registration. In this paper, we propose a sparse based similarity measure for mono-modal images that considers non-stationary intensity and spatially-varying distortions. The main idea behind this measure is that the aligned image is constructed by an analysis dictionary trained using the image patches. For this purpose, we use "Analysis K-SVD" to train the dictionary and find the sparse coefficients. We utilize image patches to construct the analysis dictionary and then we employ the proposed sparse similarity measure to find a non-rigid transformation using free form deformation (FFD). Experimental results show that the proposed approach is able to robustly register 2D and 3D images in both simulated and real cases. The proposed method outperforms other state-of-the-art similarity measures and decreases the transformation error compared to the previous methods. Even in the presence of bias field distortion, the proposed method aligns images without any preprocessing.

  15. Advanced ultrasound probes for medical imaging

    NASA Astrophysics Data System (ADS)

    Wildes, Douglas G.; Smith, L. Scott

    2012-05-01

    New medical ultrasound probe architectures and materials build upon established 1D phased array technology and provide improved imaging performance and clinical value. Technologies reviewed include 1.25D and 1.5D arrays for elevation slice thickness control; electro-mechanical and 2D array probes for real-time 3D imaging; catheter probes for imaging during minimally-invasive procedures; single-crystal piezoelectric materials for greater frequency bandwidth; and cMUT arrays using silicon MEMS in place of piezo materials.

  16. What the Internet means for the medical device industry.

    PubMed

    Frank, T

    2000-12-01

    The Internet is dramatically changing the structure of the industry. For the first time, direct communication between all suppliers and all hospitals is available. The Internet-based electronic market place not only provides the ability to choose products from a standardized catalogue, but also to send orders direct to suppliers' enterprise resource planning systems. One-to-one marketing is also becoming a reality. Medical device manufacturers are advised to test the different electronic sales and marketing initiatives that are now available.

  17. Lightweight Portable Plasma Medical Device - Plasma Engineering Research Laboratory

    DTIC Science & Technology

    2012-10-01

    oxides (NOx) are produced through N2 and O2 reactions [62, 63]. The production of NOx species is mainly dependent on the oxygen (O2) concentration...Federal, $812,594.00. Thiyagarajan, Magesh (Principal), "Plasma Assisted Microbial Decontamination for Food Product Processing Industries...processes and products including processing and preservation of food items such as 86 vegetables, fruits and packaged foods , medical devices and

  18. 76 FR 43119 - Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-20

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery... Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is... Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1436, Silver...

  19. 76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-20

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for December...

  20. 75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was...: In the Federal Register of August 16, 2010, FDA announced that a meeting of the General and...

  1. 75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This...

  2. Antimicrobial selenium nanoparticle coatings on polymeric medical devices

    NASA Astrophysics Data System (ADS)

    Tran, Phong A.; Webster, Thomas J.

    2013-04-01

    Bacteria colonization on medical devices remains one of the most serious complications following implantation. Traditional antibiotic treatment has proven ineffective, creating an increasingly high number of drug-resistant bacteria. Polymeric medical devices represent a significant portion of the total medical devices used today due to their excellent mechanical properties (such as durability, flexibility, etc). However, many polymers (such as polyvinyl chloride (PVC), polyurethane (PU) and silicone) become readily colonized and infected by bacteria immediately after use. Therefore, in this study, a novel antimicrobial coating was developed to inhibit bacterial growth on PVC, PU and silicone. Specifically, here, the aforementioned polymeric substrates were coated with selenium (Se) nanoparticles in situ. The Se-coated substrates were characterized using scanning electron microscopy, energy dispersive x-ray spectroscopy and bacteria assays. Most importantly, bacterial growth was significantly inhibited on the Se-coated substrates compared to their uncoated counterparts. The reduction of bacteria growth directly correlated with the density of Se nanoparticles on the coated substrate surfaces. In summary, these results demonstrate that Se should be further studied as a novel anti-bacterial polymeric coating material which can decrease bacteria functions without the use of antibiotics.

  3. Printable thermoelectric devices and conductive patterns for medical applications

    NASA Astrophysics Data System (ADS)

    Lee, Jungmin; Kim, Hyunjung; Chen, Linfeng; Choi, Sang H.; Varadan, Vijay K.

    2012-10-01

    Remote point-of-care is expected to revolutionize the modern medical practice, and many efforts have been made for the development of wireless health monitoring systems for continuously detecting the physiological signals of patients. To make the remote point-of-care generally accepted and widely used, it is necessary to develop cost-effective and durable wireless health monitoring systems. Printing technique will be helpful for the fabrication of high-quality and low-cost medical devices and systems because it allows high-resolution and high-speed fabrication, low material consumption and nano-sized patterning on both flexible and rigid substrates. Furthermore, application of thermoelectric generators can replace conventional batteries as the power sources for wireless health monitoring systems because thermoelectric generators can convert the wasted heat or the heat from nature into electricity which is required for the operation of the wireless health monitoring systems. In this research, we propose the concept of printable thermoelectric devices and conductive patterns for the realization of more portable and cost-effective medical devices. To print thermoelectric generators and conductive patterns on substrates, printing inks with special characteristics should be developed. For the development of thermoelectric inks, nano-structured thermoelectric materials are synthesized and characterized; and for the development of conductive inks, two kinds of surface treated carbon nanotubes are used as active materials.

  4. Antimicrobial selenium nanoparticle coatings on polymeric medical devices.

    PubMed

    Tran, Phong A; Webster, Thomas J

    2013-04-19

    Bacteria colonization on medical devices remains one of the most serious complications following implantation. Traditional antibiotic treatment has proven ineffective, creating an increasingly high number of drug-resistant bacteria. Polymeric medical devices represent a significant portion of the total medical devices used today due to their excellent mechanical properties (such as durability, flexibility, etc). However, many polymers (such as polyvinyl chloride (PVC), polyurethane (PU) and silicone) become readily colonized and infected by bacteria immediately after use. Therefore, in this study, a novel antimicrobial coating was developed to inhibit bacterial growth on PVC, PU and silicone. Specifically, here, the aforementioned polymeric substrates were coated with selenium (Se) nanoparticles in situ. The Se-coated substrates were characterized using scanning electron microscopy, energy dispersive x-ray spectroscopy and bacteria assays. Most importantly, bacterial growth was significantly inhibited on the Se-coated substrates compared to their uncoated counterparts. The reduction of bacteria growth directly correlated with the density of Se nanoparticles on the coated substrate surfaces. In summary, these results demonstrate that Se should be further studied as a novel anti-bacterial polymeric coating material which can decrease bacteria functions without the use of antibiotics.

  5. Neural networks: Application to medical imaging

    NASA Technical Reports Server (NTRS)

    Clarke, Laurence P.

    1994-01-01

    The research mission is the development of computer assisted diagnostic (CAD) methods for improved diagnosis of medical images including digital x-ray sensors and tomographic imaging modalities. The CAD algorithms include advanced methods for adaptive nonlinear filters for image noise suppression, hybrid wavelet methods for feature segmentation and enhancement, and high convergence neural networks for feature detection and VLSI implementation of neural networks for real time analysis. Other missions include (1) implementation of CAD methods on hospital based picture archiving computer systems (PACS) and information networks for central and remote diagnosis and (2) collaboration with defense and medical industry, NASA, and federal laboratories in the area of dual use technology conversion from defense or aerospace to medicine.

  6. HIPAA compliant auditing system for medical images.

    PubMed

    Zhou, Zheng; Liu, Brent J

    2005-01-01

    As an official regulation for healthcare privacy and security, Health Insurance Portability and Accountability Act (HIPAA) mandates health institutions to protect health information against unauthorized use or disclosure. One such method proposed by HIPAA Security Standards is audit trail, which records and examines health information access activities. HIPAA mandates healthcare providers to have the ability to generate audit trails on data access activities for any specific patient. Although current medical imaging systems generate activity logs, there is a lack of formal methodology to interpret these large volumes of log data and generate HIPAA compliant auditing trails. This paper outlines the design of a HIPAA compliant auditing system (HCAS) for medical images in imaging systems such as PACS and discusses the development of a security monitoring (SM) toolkit based on some of the partial components in HCAS.

  7. Materials Advances for Next-Generation Ingestible Electronic Medical Devices.

    PubMed

    Bettinger, Christopher J

    2015-10-01

    Electronic medical implants have collectively transformed the diagnosis and treatment of many diseases, but have many inherent limitations. Electronic implants require invasive surgeries, operate in challenging microenvironments, and are susceptible to bacterial infection and persistent inflammation. Novel materials and nonconventional device fabrication strategies may revolutionize the way electronic devices are integrated with the body. Ingestible electronic devices offer many advantages compared with implantable counterparts that may improve the diagnosis and treatment of pathologies ranging from gastrointestinal infections to diabetes. This review summarizes current technologies and highlights recent materials advances. Specific focus is dedicated to next-generation materials for packaging, circuit design, and on-board power supplies that are benign, nontoxic, and even biodegradable. Future challenges and opportunities are also highlighted.

  8. Optical design of low cost imaging systems for mobile medical applications

    NASA Astrophysics Data System (ADS)

    Kass, Alexander; Slyper, Ronit; Levitz, David

    2015-03-01

    Colposcopes, the gold standard devices for imaging the cervix at high magnfication, are expensive and sparse in low resource settings. Using a lens attachment, any smartphone camera can be turned into an imaging device for tissues such as the cervix. We create a smartphone-based colposcope using a simple lens design for high magnification. This particular design is useful because it allows parameters such as F-number, depth of field, and magnification to be controlled easily. We were therefore able to determine a set of design steps which are general to mobile medical imaging devices and allow them to maintain requisite image quality while still being rugged and affordable.

  9. Tiny Devices Project Sharp, Colorful Images

    NASA Technical Reports Server (NTRS)

    2009-01-01

    Displaytech Inc., based in Longmont, Colorado and recently acquired by Micron Technology Inc. of Boise, Idaho, first received a Small Business Innovation Research contract in 1993 from Johnson Space Center to develop tiny, electronic, color displays, called microdisplays. Displaytech has since sold over 20 million microdisplays and was ranked one of the fastest growing technology companies by Deloitte and Touche in 2005. Customers currently incorporate the microdisplays in tiny pico-projectors, which weigh only a few ounces and attach to media players, cell phones, and other devices. The projectors can convert a digital image from the typical postage stamp size into a bright, clear, four-foot projection. The company believes sales of this type of pico-projector may exceed $1.1 billion within 5 years.

  10. Digital Pathology: Data-Intensive Frontier in Medical Imaging

    PubMed Central

    Cooper, Lee A. D.; Carter, Alexis B.; Farris, Alton B.; Wang, Fusheng; Kong, Jun; Gutman, David A.; Widener, Patrick; Pan, Tony C.; Cholleti, Sharath R.; Sharma, Ashish; Kurc, Tahsin M.; Brat, Daniel J.; Saltz, Joel H.

    2013-01-01

    Pathology is a medical subspecialty that practices the diagnosis of disease. Microscopic examination of tissue reveals information enabling the pathologist to render accurate diagnoses and to guide therapy. The basic process by which anatomic pathologists render diagnoses has remained relatively unchanged over the last century, yet advances in information technology now offer significant opportunities in image-based diagnostic and research applications. Pathology has lagged behind other healthcare practices such as radiology where digital adoption is widespread. As devices that generate whole slide images become more practical and affordable, practices will increasingly adopt this technology and eventually produce an explosion of data that will quickly eclipse the already vast quantities of radiology imaging data. These advances are accompanied by significant challenges for data management and storage, but they also introduce new opportunities to improve patient care by streamlining and standardizing diagnostic approaches and uncovering disease mechanisms. Computer-based image analysis is already available in commercial diagnostic systems, but further advances in image analysis algorithms are warranted in order to fully realize the benefits of digital pathology in medical discovery and patient care. In coming decades, pathology image analysis will extend beyond the streamlining of diagnostic workflows and minimizing interobserver variability and will begin to provide diagnostic assistance, identify therapeutic targets, and predict patient outcomes and therapeutic responses. PMID:25328166

  11. Infections associated with medical devices: pathogenesis, management and prophylaxis.

    PubMed

    von Eiff, Christof; Jansen, Bernd; Kohnen, Wolfgang; Becker, Karsten

    2005-01-01

    The insertion or implantation of foreign bodies has become an indispensable part in almost all fields of medicine. However, medical devices are associated with a definitive risk of bacterial and fungal infections. Foreign body-related infections (FBRIs), particularly catheter-related infections, significantly contribute to the increasing problem of nosocomial infections. While a variety of micro-organisms may be involved as pathogens, staphylococci account for the majority of FBRIs. Their ability to adhere to materials and to promote formation of a biofilm is the most important feature of their pathogenicity. This biofilm on the surface of colonised foreign bodies is regarded as the biological correlative for the clinical experience with FBRI, that is, that the host defence mechanisms often seem to be unable to handle the infection and, in particular, to eliminate the micro-organisms from the infected device. Since antibacterial chemotherapy is also frequently not able to cure these infections despite the use of antibacterials with proven in vitro activity, removal of implanted devices is often inevitable and has been standard clinical practice. However, in specific circumstances, such as infections of implanted medical devices with coagulase-negative staphylococci, a trial of salvage of the device may be justified. All FBRIs should be treated with antibacterials to which the pathogens have been shown to be susceptible. In addition to systemic antibacterial therapy, an intraluminal application of antibacterial agents, referred to as the 'antibiotic-lock' technique, should be considered to circumvent the need for removal, especially in patients with implanted long-term catheters. To reduce the incidence of intravascular catheter-related bloodstream infections, specific guidelines comprising both technological and nontechnological strategies for prevention have been established. Quality assurance, continuing education, choice of the catheter insertion site, hand

  12. Imaging-related medications: a class overview

    PubMed Central

    2007-01-01

    Imaging-related medications (contrast agents) are commonly utilized to improve visualization of radiographic, computed tomography (CT), and magnetic resonance (MR) images. While traditional medications are used specifically for their pharmacological actions, the ideal imaging agent provides enhanced contrast with little biological interaction. The radiopaque agents, barium sulfate and iodinated contrast agents, confer “contrast” to x-ray films by their physical ability to directly absorb x-rays. Gadolinium-based MR agents enhance visualization of tissues when exposed to a magnetic field. Ferrous-ferric oxide–based paramagnetic agents provide negative contrast for MR liver studies. This article provides an overview of clinically relevant information for the imaging-related medications commonly in use. It reviews the safety improvements in new generations of drugs; risk factors and precautions for the reduction of severe adverse reactions (i.e., extravasation, contrast-induced nephropathy, metformin-induced lactic acidosis, and nephrogenic fibrosing dermopathy/nephrogenic systemic fibrosis); and the significance of diligent patient screening before contrast exposure and appropriate monitoring after exposure. PMID:17948119

  13. 75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ... No. FDA-2010-N-0427] Public Workshop on Medical Devices and Nanotechnology: Manufacturing... public workshop entitled ``Medical Devices & Nanotechnology: Manufacturing, Characterization, and... statement that describes your experience or expertise with nanotechnology. There will be a limited number...

  14. Nanostructured selenium for preventing biofilm formation on polycarbonate medical devices.

    PubMed

    Wang, Qi; Webster, Thomas J

    2012-12-01

    Biofilms are a common cause of persistent infections on medical devices as they are easy to form and hard to treat. The objective of this study was for the first time to coat selenium (a natural element in the body) nanoparticles on the surface of polycarbonate medical devices (such as those used for medical catheters) and to examine their effectiveness at preventing biofilm formation. The size and distribution of selenium coatings were characterized using scanning electron microscopy and atomic force microscopy. The strength of the selenium coating on polycarbonate was assessed by tape-adhesion tests followed by atomic absorption spectroscopy. Results showed that selenium nanoparticles had a diameter of 50-100 nm and were well distributed on the polycarbonate surface. In addition, more than 50% of the selenium coating survived the tape-adhesion test as larger nanoparticles had less adhesion strength to the underlying polycarbonate substrate than smaller selenium nanoparticles. Most significantly, the results of this in vitro study showed that the selenium coatings on polycarbonate significantly inhibited Staphylococcus aureus growth to 8.9% and 27% when compared with an uncoated polycarbonate surface after 24 and 72 h, respectively. Importantly, this was accomplished without using antibiotics but rather with an element (selenium) that is natural to the human body. Thus, this study suggests that coating polymers (particularly, polycarbonate) with nanostructured selenium is a fast and effective way to reduce bacteria functions that lead to medical device infections. © 2012 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 100A: 3205-3210, 2012.

  15. Medical devices and pharmaceuticals: differences in public acceptance.

    PubMed

    Holmes, David R; Wood, Douglas L

    2006-01-01

    In the past 15 years, rapid technologic advances have introduced medical devices for clinical use that have transformed the care of patients with chronic diseases, especially heart disease. These devices have become truly lifesaving, and their effectiveness has been demonstrated in randomized clinical trials and cost-effectiveness studies. At the same time, a remarkable number of pharmaceutical agents with new actions and capabilities have also been introduced into clinical use. These new compounds have altered the practice of oncology and the care of patients with hematologic malignancies, sometimes with significant improvement in survival. There have been other drugs introduced to manage chronic diseases that alter quality of life but do not usually threaten survival. Recent problems related to the COX-2 anti-inflammatory drugs and ongoing controversies associated with them have raised public awareness; however, there is even more concern about device failures and recalls that have occurred during the same time frame. There is limited information as to why there is such an apparent difference in public opinion toward adverse drug events compared with device problems that lead to advisories or recalls. Among possible reasons are that an implantable device that requires a catheter-based surgical procedure, with its need for hospitalization and detailed explanation about all the potential risks, may be emotionally and intellectually processed differently by a patient/family compared with having a change in prescription from one drug to another.

  16. Image readout device with electronically variable spatial resolution

    NASA Astrophysics Data System (ADS)

    Benz, H. A.

    1981-07-01

    An invention relating to the use of a standing acoustic wave charge storage device as an image readout device is described. A frequency f sub 1 was applied to the storage transfer device to create a traveling electric field in the device in one direction along a straight line. A second frequency f sub 2 was applied to the charge transfer device to create a traveling electric field opposite to the first traveling electric field. A standing wave was created. When an image was focused on the charge transfer device, light was stored in the wells of the standing wave. When the frequency f sub 2 is removed from the device, the standing wave tends to break up and the charges stored move to an electrode connected to an output terminal and to a utilization device where the received charges represent the image on the surface of the charge transfer device along a projection of said straight line.

  17. An example of US Food and Drug Administration device regulation: medical devices indicated for use in acute ischemic stroke.

    PubMed

    Peña, Carlos; Li, Khan; Felten, Richard; Ogden, Neil; Melkerson, Mark

    2007-06-01

    The Food and Drug Administration has established requirements for protecting the public health by assuring the safety and effectiveness of a variety of medical products including drugs, devices, and biological products, and for promoting public health by expediting the approval of treatments that are safe and effective. The Center for Devices and Radiological Health is the center within the agency that is responsible for pre- and postmarket regulation of medical devices. In this article, we review current regulation of medical devices, research and development programs, pre- and postmarket perspectives, and future considerations of medical devices, particularly as they relate to devices targeting acute ischemic stroke as an example of the process. We also review the Center for Devices and Radiological Health's historical perspective of acute ischemic stroke trials and clinical trial design considerations used in prior studies that have led to US market clearance as they are related to currently marketed devices indicated for acute ischemic stroke.

  18. Optical medical imaging: from glass to man

    NASA Astrophysics Data System (ADS)

    Bradley, Mark

    2016-11-01

    A formidable challenge in modern respiratory healthcare is the accurate and timely diagnosis of lung infection and inflammation. The EPSRC Interdisciplinary Research Collaboration (IRC) `Proteus' seeks to address this challenge by developing an optical fibre based healthcare technology platform that combines physiological sensing with multiplexed optical molecular imaging. This technology will enable in situ measurements deep in the human lung allowing the assessment of tissue function and characterization of the unique signatures of pulmonary disease and is illustrated here with our in-man application of Optical Imaging SmartProbes and our first device Versicolour.

  19. Development and clinical translation of OTIS: a wide-field OCT imaging device for ex-vivo tissue characterization

    NASA Astrophysics Data System (ADS)

    Munro, Elizabeth A.; Rempel, David; Danner, Christine; Atchia, Yaaseen; Valic, Michael S.; Berkeley, Andrew; Davoudi, Bahar; Magnin, Paul A.; Akens, Margarete; Done, Susan J.; Kulkarni, Supriya; Leong, Wey-Liang; Wilson, Brian C.

    2016-03-01

    We have developed an automated, wide-field optical coherence tomography (OCT)-based imaging device (OTISTM Perimeter Medical Imaging) for peri-operative, ex-vivo tissue imaging. This device features automated image acquisition, enabling rapid capture of high-resolution (15 μm) OCT images from samples up to 10 cm in diameter. We report on the iterative progression of device development from phantom and pre-clinical (tumor xenograft) models through to initial clinical results. We discuss the challenges associated with proving a novel imaging technology against the clinical "gold standard" of conventional post-operative pathology.

  20. [The management of implantable medical device and the application of the internet of things in hospitals].

    PubMed

    Zhou, Li; Xu, Liang

    2011-11-01

    Implantable medical device is a special product which belongs to medical devices. It not only possesses product characteristics in common, but also has specificity for safety and effectiveness. Implantable medical device must be managed by the relevant laws and regulations of the State Food and Drug Administration. In this paper, we have used cardiac pacemakers as an example to describe the significance of the management of implantable medical device products and the application of the internet of things in hospitals.

  1. Simplified labeling process for medical image segmentation.

    PubMed

    Gao, Mingchen; Huang, Junzhou; Huang, Xiaolei; Zhang, Shaoting; Metaxas, Dimitris N

    2012-01-01

    Image segmentation plays a crucial role in many medical imaging applications by automatically locating the regions of interest. Typically supervised learning based segmentation methods require a large set of accurately labeled training data. However, thel labeling process is tedious, time consuming and sometimes not necessary. We propose a robust logistic regression algorithm to handle label outliers such that doctors do not need to waste time on precisely labeling images for training set. To validate its effectiveness and efficiency, we conduct carefully designed experiments on cervigram image segmentation while there exist label outliers. Experimental results show that the proposed robust logistic regression algorithms achieve superior performance compared to previous methods, which validates the benefits of the proposed algorithms.

  2. Web-based platform for collaborative medical imaging research

    NASA Astrophysics Data System (ADS)

    Rittner, Leticia; Bento, Mariana P.; Costa, André L.; Souza, Roberto M.; Machado, Rubens C.; Lotufo, Roberto A.

    2015-03-01

    Medical imaging research depends basically on the availability of large image collections, image processing and analysis algorithms, hardware and a multidisciplinary research team. It has to be reproducible, free of errors, fast, accessible through a large variety of devices spread around research centers and conducted simultaneously by a multidisciplinary team. Therefore, we propose a collaborative research environment, named Adessowiki, where tools and datasets are integrated and readily available in the Internet through a web browser. Moreover, processing history and all intermediate results are stored and displayed in automatic generated web pages for each object in the research project or clinical study. It requires no installation or configuration from the client side and offers centralized tools and specialized hardware resources, since processing takes place in the cloud.

  3. Hyperspectral imaging applied to medical diagnoses and food safety

    NASA Astrophysics Data System (ADS)

    Carrasco, Oscar; Gomez, Richard B.; Chainani, Arun; Roper, William E.

    2003-08-01

    This paper analyzes the feasibility and performance of HSI systems for medical diagnosis as well as for food safety. Illness prevention and early disease detection are key elements for maintaining good health. Health care practitioners worldwide rely on innovative electronic devices to accurately identify disease. Hyperspectral imaging (HSI) is an emerging technique that may provide a less invasive procedure than conventional diagnostic imaging. By analyzing reflected and fluorescent light applied to the human body, a HSI system serves as a diagnostic tool as well as a method for evaluating the effectiveness of applied therapies. The safe supply and production of food is also of paramount importance to public health illness prevention. Although this paper will focus on imaging and spectroscopy in food inspection procedures -- the detection of contaminated food sources -- to ensure food quality, HSI also shows promise in detecting pesticide levels in food production (agriculture.)

  4. Organisational impact: Definition and assessment methods for medical devices.

    PubMed

    Roussel, Christophe; Carbonneil, Cédric; Audry, Antoine

    2016-02-01

    Health technology assessment (HTA) is a rapidly developing area and the value of taking non-clinical fields into consideration is growing. Although the health-economic aspect is commonly recognised, evaluating organisational impact has not been studied nearly as much. The goal of this work was to provide a definition of organisational impact in the sector of medical devices by defining its contours and exploring the evaluation methods specific to this field. Following an analysis of the literature concerning the impact of technologies on organisations as well as the medical literature, and also after reviewing the regulatory texts in this respect, the group of experts identified 12 types of organisational impact. A number of medical devices were carefully screened using the criteria grid, which proved to be operational and to differentiate properly. From the analysis of the practice and of the methods described, the group was then able to derive a few guidelines to successfully evaluate organisational impact. This work shows that taking organisational impact into consideration may be critical alongside of the other criteria currently in favour (clinically and economically). What remains is to confer a role in the decision-making process on this factor and one that meets the economic efficiency principle.

  5. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury Regulations... Policy § 560.533 Brokering sales of agricultural commodities, medicine, and medical devices. (a) General... agricultural commodities, medicine, and medical devices, provided that the sale and exportation...

  6. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury Regulations... Policy § 560.533 Brokering sales of agricultural commodities, medicine, and medical devices. (a) General... of agricultural commodities, medicine, and medical devices, provided that the sale and exportation...

  7. 75 FR 45641 - Medical Device User Fee Rates for Fiscal Year 2011

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Medical Device User Fee Rates for Fiscal Year 2011 AGENCY... announcing the ] fee rates and payment procedures for medical device user fees for fiscal year (FY) 2011. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee Amendments...

  8. 76 FR 17657 - Medical Device Epidemiology Network 2011: Second Annual Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-30

    ... HUMAN SERVICES Food and Drug Administration Medical Device Epidemiology Network 2011: Second Annual... and Drug Administration (FDA) is announcing a public workshop entitled ``Medical Device Epidemiology... for studying medical device performance. Date and Time: The public workshop will be held on April...

  9. [The Feasibility Study on the Application of Global Medical Device Nomenclature(GMDN)].

    PubMed

    Yang, Wanjuan; Zheng, Jian; Li, Jun; Huang, Ying; Zhang, Chunqing; Li, Jingli

    2015-09-01

    The article has analyzed the policy co-ordination, Industry coverage and technical experience of the global medical device nomenclature (GMDN) to our country, argued the feasibility on the application of GMDN in our medical device administration system, provided some reference on building the naming system of medical device in our country.

  10. 37 CFR 1.777 - Calculation of patent term extension for a medical device.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... extension for a medical device. 1.777 Section 1.777 Patents, Trademarks, and Copyrights UNITED STATES PATENT... term extension for a medical device. (a) If a determination is made pursuant to § 1.750 that a patent for a medical device is eligible for extension, the term shall be extended by the time as...

  11. 75 FR 58414 - Dental Products Panel of the Medical Devices Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-24

    ... HUMAN SERVICES Food and Drug Administration Dental Products Panel of the Medical Devices Advisory... Medical Devices Advisory Committee. This meeting was announced in the Federal Register of June 11, 2010... announced that a meeting of the Dental Products Panel of the Medical Devices Advisory Committee would...

  12. 37 CFR 1.777 - Calculation of patent term extension for a medical device.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... extension for a medical device. 1.777 Section 1.777 Patents, Trademarks, and Copyrights UNITED STATES PATENT... term extension for a medical device. (a) If a determination is made pursuant to § 1.750 that a patent for a medical device is eligible for extension, the term shall be extended by the time as...

  13. 37 CFR 1.777 - Calculation of patent term extension for a medical device.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... extension for a medical device. 1.777 Section 1.777 Patents, Trademarks, and Copyrights UNITED STATES PATENT... term extension for a medical device. (a) If a determination is made pursuant to § 1.750 that a patent for a medical device is eligible for extension, the term shall be extended by the time as...

  14. [The Analysis on Application of Global Medical Device Nomenclature(GMDN)].

    PubMed

    Yang, Wanjuan; Li, Jun; Li, Jingli

    2015-07-01

    The article has reviewed the administration technical structure and global application of the global medical device nomenclature(GMDN), analyzed the coordination between GMDN and the industry status of medical device in our country, put forward some suggestions on the applicaition of GMDN, provided some reference on raising the management level of medical device in our country.

  15. 31 CFR 538.526 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... commodities, medicine, and medical devices. 538.526 Section 538.526 Money and Finance: Treasury Regulations... Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for... agricultural commodities, medicine, and medical devices to the Government of Sudan, to any individual or...

  16. 31 CFR 538.526 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... commodities, medicine, and medical devices. 538.526 Section 538.526 Money and Finance: Treasury Regulations... Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for... agricultural commodities, medicine, and medical devices to the Government of Sudan, to any individual or...

  17. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury Regulations... Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for... agricultural commodities, medicine, and medical devices, provided that the sale and exportation...

  18. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury Regulations... Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for... agricultural commodities, medicine, and medical devices, provided that the sale and exportation...

  19. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Transitional pass-through payments: Medical devices... DEPARTMENT SERVICES Transitional Pass-through Payments § 419.66 Transitional pass-through payments: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets...

  20. 78 FR 33849 - Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ... No. FDA-2013-N-0580] Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public... entitled ``Battery-Powered Medical Devices Workshop: Challenges and Opportunities''. The purpose of this workshop is to create awareness of the challenges related to battery-powered medical devices...

  1. 76 FR 18227 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-01

    ... HUMAN SERVICES Food and Drug Administration Molecular and Clinical Genetics Panel of the Medical Devices... Molecular and Clinical Genetics Panel (the panel) of the Medical Devices Advisory Committee that published... meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, and...

  2. 21 CFR 801.18 - Format of dates provided on a medical device label.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Format of dates provided on a medical device label. 801.18 Section 801.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... on a medical device label. (a) In general. Whenever the label of a medical device includes a...

  3. Medical imaging displays and their use in image interpretation.

    PubMed

    Kagadis, George C; Walz-Flannigan, Alisa; Krupinski, Elizabeth A; Nagy, Paul G; Katsanos, Konstantinos; Diamantopoulos, Athanasios; Langer, Steve G

    2013-01-01

    The adequate and repeatable performance of the image display system is a key element of information technology platforms in a modern radiology department. However, despite the wide availability of high-end computing platforms and advanced color and gray-scale monitors, the quality and properties of the final displayed medical image may often be inadequate for diagnostic purposes if the displays are not configured and maintained properly. In this article-an expanded version of the Radiological Society of North America educational module "Image Display"-the authors discuss fundamentals of image display hardware, quality control and quality assurance processes for optimal image interpretation settings, and parameters of the viewing environment that influence reader performance. Radiologists, medical physicists, and other allied professionals should strive to understand the role of display technology and proper usage for a quality radiology practice. The display settings and display quality control and quality assurance processes described in this article can help ensure high standards of perceived image quality and image interpretation accuracy.

  4. Machine learning for medical images analysis.

    PubMed

    Criminisi, A

    2016-10-01

    This article discusses the application of machine learning for the analysis of medical images. Specifically: (i) We show how a special type of learning models can be thought of as automatically optimized, hierarchically-structured, rule-based algorithms, and (ii) We discuss how the issue of collecting large labelled datasets applies to both conventional algorithms as well as machine learning techniques. The size of the training database is a function of model complexity rather than a characteristic of machine learning methods.

  5. Visual performance in medical imaging using liquid crystal displays

    NASA Astrophysics Data System (ADS)

    Tchou, Philip Marcel

    2007-12-01

    This thesis examined the contrast performance of liquid crystal display (LCD) devices for use in medical imaging. Novel experimental methods were used to measure the ability of medical LCD devices to produce just noticeable contrast. It was demonstrated that medical LCD devices are capable of high performance in medical imaging and are suitable for conducting psychovisual research experiments. Novel methods for measuring and controlling the luminance response of an LCD were presented in Chapter 3 and used to develop a software tools to apply DICOM GSDF calibrations. Several medical LCD systems were calibrated, demonstrating that the methods can be used to reliably measure luminance and manipulate fine contrast. Chapter 4 reports on a novel method to generate low contrast bi-level bar patterns by using the full palette of available gray values. The method was used in a two alternative forced choice (2AFC) psychovisual experiment to measure the contrast threshold of human observers. Using a z-score analysis method, the results were found to be consistent with the Barten model of contrast sensitivity. Chapter 5 examined error distortion associated with using z-scores. A maximum likelihood estimation (MLE) method was presented as an alternative and was used to reevaluate the results from Chapter 4. The new results were consistent with the Barten model. Simulations were conducted to evaluate the statistical precision of the MLE method in relation to the number and distribution of trials. In Chapter 6, 2AFC tests were conducted examining contrast thresholds for complex sinusoid, white noise, and filtered noise patterns. The sinusoid test results were consistent with the Barten model while the noise patterns required more contrast for visibility. The effects of adaptation were also demonstrated. A noise visibility index (NVI) was introduced to describe noise power weighted by contrast sensitivity. Just noticeable white and filtered noise patterns exhibited similar NVI

  6. Medical Image Intensifier In 1980 (What Really Happened)

    NASA Astrophysics Data System (ADS)

    Baiter, Stephen; Kuhl, Walter

    1980-08-01

    In 1972, at the first SPIE seminar covering the application of optical instrumentation in medicine, Balter and Stanton presented a paper forecasting the status of x-ray image intensifiers in the year 1980. Now, eight years later, it is 1980, and it seems a good idea to evaluate these forecasts in the light of what has actually happened. The x-ray sensitive image intensifier tube (with cesium iodide as an input phosphor) is used nearly universally. Input screen sizes range from 15 cm to 36 cm in diameter. Real time monitoring of both fluoroscopic and fluorographic examinations is generally performed via closed circuit television. Archival recording of images is carried out using cameras with film formats of approximately 100 mm for single exposure or serial fluorography and 35 mm for cine fluorography. With the detective quantum efficiency of image intensifier tubes remaining near 50% throughout the decade, the noise content of most fluorographic and fluoroscopic images is still determined by the input exposure. Consequently, patient doses today, in 1980, have not substantially changed in the last ten years. There is, however, interest in uncoupling the x-ray dose and the image brightness by providing a variable optical diaphragm between the output of the image intensifier tube and the recording devices. During the past eight years, there has been a major philosophical change in the approach to imaging systems. It is now realized that medical image quality is much more dependent on the reduction of large area contrast losses than on the limiting resolution of the imaging system. It has also been clear that much diagnostic information is carried by spatial frequencies in the neighborhood of one line pair per millimeter (referred to the patient). The design of modern image intensifiers has been directed toward improvement in the large area contrast by minimizing x-ray and optical scatter in both the image intensifier tube and its associated components.

  7. Navigating conflicts of interest for the medical device entrepreneur.

    PubMed

    Donovan, Aine; Kaplan, Aaron V

    2012-01-01

    The past fifty years has witnessed dramatic progress in the understanding and treatment of patients suffering from cardiovascular disease leading to symptomatic relief and impressive increases in longevity. These advances have been due in large part to the development, study and implementation of new technology. Within interventional cardiology in particular, these advances have been driven by the availability of new technology in the form of medical devices. Successful device development efforts require close collaboration among basic scientist, clinician-inventors/entrepreneurs, clinician-investigators and corporations. Though the role of the clinician is central to this process, these activities present important conflicts-of-interest (COIs). The purpose of this paper is to 1) characterize these conflicts, 2) provide a context from which to approach their management and 3) recommend management strategies.

  8. Emerging medical devices for minimally invasive cell therapy.

    PubMed

    O'Cearbhaill, Eoin D; Ng, Kelvin S; Karp, Jeffrey M

    2014-02-01

    The past decade has seen the first wave of cell-based therapeutics undergo clinical trials with varying degrees of success. Although attention is increasingly focused on clinical trial design, owing to spiraling regulatory costs, tools used in delivering cells and sustaining the cells' viability and functions in vivo warrant careful scrutiny. While the clinical administration of cell-based therapeutics often requires additional safeguarding and targeted delivery compared with traditional therapeutics, there is significant opportunity for minimally invasive device-assisted cell therapy to provide the physician with new regenerative options at the point of care. Herein we detail exciting recent advances in medical devices that will aid in the safe and efficacious delivery of cell-based therapeutics.

  9. Medical regulation of cognitive enhancement devices: some concerns

    PubMed Central

    King, Mike; Gavaghan, Colin; McMillan, John

    2014-01-01

    The authors present a cogent and detailed case for altering the Medical Devices Directive to allow regulation of cognitive enhancement devices (CEDs). Protection against significant risk of harm, especially for the vulnerable, and promotion of benefit through informed use of CEDs are all good features of the proposal. However, the pre-market approval process has limitations, which we explore. We raise the possibility of ‘risk compensation’ in response to the introduction of safety measures, which could alter its effectiveness. The proposal alludes to use of ‘formally trained practitioners,’ which provide a further tier of regulation for CEDs within the proposal. We consider some positive and negative implications of this aspect of the proposal that might warrant further consideration. PMID:27774173

  10. Development of medical electronic devices in the APL space department

    NASA Technical Reports Server (NTRS)

    Newman, A. L.

    1985-01-01

    Several electronic devices for automatically correcting specific defects in a body's physiologic regulation and allowing approximately normal functioning are described. A self-injurious behavior inhibiting system (SIBIS) is fastened to the arm of a person with chronic self-injurious behavior patterns. An electric shock is delivered into the arm whenever the device senses above-threshold acceleration of the head such as occur with head-bangers. Sounding a buzzer tone with the shock eventually allows transference of the aversive stimulus to the buzzer so shocks are no longer necessary. A programmable implantable medication system features a solenoid pump placed beneath the skin and refueled by hypodermic needle. The pump functions are programmable and can deliver insulin, chemotherapy mixes and/or pain killers according to a preset schedule or on patient demand. Finally, an automatic implantible defibrillator has four electrodes attached directly to the heart for sensing electrical impulses or emitting them in response to cardiac fibrillation.

  11. [The choice of inhalation device: A medical act].

    PubMed

    Devillier, P; Salvator, H; Roche, N

    2015-06-01

    Inhaled treatments are essential for respiratory diseases management, including COPD and asthma. Optimal control of the disease largely depends on patient's compliance and proper use of these treatments. Different types of ready-to-use inhaler devices are available: metered dose inhaler, dry powder inhaler or soft mist inhaler. Each of these devices presents specific characteristics and constraints that have to be evaluated and taken into account before prescription. In order to optimize adherence and treatment efficacy, the choice of inhaler device should depend on the specific needs, abilities and preferences of each patient and a specific education to treatment should be provided. Inhaled treatments, even containing the same drug, have different technical constraints and are thus not easily interchangeable. Their substitution without prior medical consent and without proper training can lead to errors in taking treatment, treatment failures and increased health care consumption. In France, substitution by the pharmacist is not authorized. While patient education must be carried out in collaboration with all health professionals, it is preferable that the choice of inhaler device remains the responsibility of the physician.

  12. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Suppliers for sealed sources or devices for medical use. 35.49 Section 35.49 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Administrative Requirements § 35.49 Suppliers for sealed sources or devices for medical use. For medical use,...

  13. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Suppliers for sealed sources or devices for medical use. 35.49 Section 35.49 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Administrative Requirements § 35.49 Suppliers for sealed sources or devices for medical use. For medical use,...

  14. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Suppliers for sealed sources or devices for medical use. 35.49 Section 35.49 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Administrative Requirements § 35.49 Suppliers for sealed sources or devices for medical use. For medical use,...

  15. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Suppliers for sealed sources or devices for medical use. 35.49 Section 35.49 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Administrative Requirements § 35.49 Suppliers for sealed sources or devices for medical use. For medical use,...

  16. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Suppliers for sealed sources or devices for medical use. 35.49 Section 35.49 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Administrative Requirements § 35.49 Suppliers for sealed sources or devices for medical use. For medical use,...

  17. Assessment and non-clinical impact of medical devices.

    PubMed

    Dervaux, Benoît; Szwarcensztein, Karine; Josseran, Anne; Barna, Alexandre; Carbonneil, Cédric; Chevrie, Karine; Debroucker, Frédérique; Grumblat, Anne; Grumel, Olivier; Massol, Jacques; Maugendre, Philippe; Méchin, Hubert; Orlikowski, David; Roussel, Christophe; Rumeau-Pichon, Catherine; Sales, Jean-Patrick; Vicaut, Eric

    2015-01-01

    Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion.

  18. Atmospheric Pressure Plasmas for Decontamination of Complex Medical Devices

    NASA Astrophysics Data System (ADS)

    Weltmann, Klaus-Dieter; Winter, Jörn; Polak, Martin; Ehlbeck, Jörg; von Woedtke, Thomas

    Atmospheric pressure plasma sources produce a multiplicity of different antimicrobial agents and are applicable to even complicated geometries as well as to heat sensitive materials. Thus, atmospheric pressure plasmas have a huge potential for the decontamination of even complex medical devices like central venous catheters and endoscopes. In this paper we present practicable realizations of atmospheric pressure plasma sources, namely plasma jet, dielectric barrier discharge and microwave driven discharge that are able to penetrate fine lumen or are adaptable to difficult geometries. Furthermore, the antimicrobial efficacy of these sources is given for one example setup in each case.

  19. New regulations on medical devices in Europe: what to expect?

    PubMed

    Fouretier, Alice; Bertram, Delphine

    2014-07-01

    Medical devices (MDs) contribute to improve quality and effectiveness of healthcare. The MD industry is a heterogeneous, innovative, dynamic and growing sector. The existing regulatory framework for MDs has been in place for 20 years and needed a revision. In September 2012, the European Commission published a proposal for a new regulation on MDs which was amended by the Parliament in October 2013. This new regulation aims to harmonize practices, increase transparency and guarantee a high level of health protection. We conducted an analysis of the proposal to highlight the major upcoming changes.

  20. Bayesian statistics in medical devices: innovation sparked by the FDA.

    PubMed

    Campbell, Gregory

    2011-09-01

    Bayesian statistical methodology has been used for more than 10 years in medical device premarket submissions to the U.S. Food and Drug Administration (FDA). A complete list of the publicly available information associated with these FDA applications is presented. In addition to the increasing number of Bayesian methodological papers in the statistical journals, a number of successful Bayesian clinical trials in the biomedical journals have been recently reported. Some challenges that require more methodological development are discussed. The promise of using Bayesian methods for incorporation of prior information as well as for conducting adaptive trials is great.

  1. Safety and cleaning of medical materials and devices.

    PubMed

    Merritt, K; Hitchins, V M; Brown, S A

    2000-01-01

    A study was undertaken to evaluate different procedures to safely remove microorganisms, protein, and mammalian cells from materials and provide a suitable method for cleaning and assessing effectiveness of cleaning medical devices for reuse or for analysis of failure. Safety considerations for the personnel performing the cleaning or handling the device after cleaning are important issues. Polystyrene plates (96 well) were used to simulate device surfaces not amenable to manual scrubbing. Staphylococcus epidermidis, Candida albicans, Escherichia coli, Pseudomonas aeruginosa, and oral flora were grown in the plates. The plates were stained with crystal violet and the optical densities recorded. The results indicated that E. coli did not adhere well and Pseudomonas formed clumps that were easily detached from the surface of the plates. However, S. epi, C. albicans, and the oral organisms formed adherent biofilms that were difficult to remove from the plates. Detergents with enzymes and sodium hypochlorite (NaOCl) bleach were both effective in removing the biofilm. Other detergents and surfactants were not effective. The aldehyde agents did not remove the organisms and made further cleaning difficult. Allowing the biofilm to dry first made cleaning very difficult. Only the NaOCl bleach could subsequently remove the dried or aldehyde fixed organisms from the wells. The same 96-well polystyrene plate format was used to measure the amount of protein and cell adherence as well as the effectiveness of subsequent cleaning. Bradford reagent was used to detect protein as a measure of the cleaning efficacy. As with the bacteria, NaOCl bleach was effective at removing the protein and cells that had been dried or fixed by formalin or alcohol, whereas detergent with enzymes was not very effective. This study confirmed that used medical devices, contaminated with microorganisms, protein, and/or mammalian cells, should not be allowed to dry before cleaning and that a thorough

  2. Interpretation of Medical Imaging Data with a Mobile Application: A Mobile Digital Imaging Processing Environment

    PubMed Central

    Lin, Meng Kuan; Nicolini, Oliver; Waxenegger, Harald; Galloway, Graham J.; Ullmann, Jeremy F. P.; Janke, Andrew L.

    2013-01-01

    Digital Imaging Processing (DIP) requires data extraction and output from a visualization tool to be consistent. Data handling and transmission between the server and a user is a systematic process in service interpretation. The use of integrated medical services for management and viewing of imaging data in combination with a mobile visualization tool can be greatly facilitated by data analysis and interpretation. This paper presents an integrated mobile application and DIP service, called M-DIP. The objective of the system is to (1) automate the direct data tiling, conversion, pre-tiling of brain images from Medical Imaging NetCDF (MINC), Neuroimaging Informatics Technology Initiative (NIFTI) to RAW formats; (2) speed up querying of imaging measurement; and (3) display high-level of images with three dimensions in real world coordinates. In addition, M-DIP provides the ability to work on a mobile or tablet device without any software installation using web-based protocols. M-DIP implements three levels of architecture with a relational middle-layer database, a stand-alone DIP server, and a mobile application logic middle level realizing user interpretation for direct querying and communication. This imaging software has the ability to display biological imaging data at multiple zoom levels and to increase its quality to meet users’ expectations. Interpretation of bioimaging data is facilitated by an interface analogous to online mapping services using real world coordinate browsing. This allows mobile devices to display multiple datasets simultaneously from a remote site. M-DIP can be used as a measurement repository that can be accessed by any network environment, such as a portable mobile or tablet device. In addition, this system and combination with mobile applications are establishing a virtualization tool in the neuroinformatics field to speed interpretation services. PMID:23847587

  3. ICG fluorescence imaging and its medical applications

    NASA Astrophysics Data System (ADS)

    Miwa, Mitsuharu; Shikayama, Takahiro

    2008-12-01

    This paper presents a novel optical angiography system, and introduces its medical applications. We developed the optical enhanced imaging system which can observe the blood and lymphatic vessels as the Indocyanine green (ICG) fluorescence image. The imaging system consists of 760nm light emitted diode (LED) as excite light, CCD camera as a detector, a high-pass optical filter in front of the CCD and video processing system. The advantage of ICG fluorescence method is safe (radiation free), high sensitive, real time monitoring of blood and/or lymphatic flow, small size, easy to operate and cost effective compared to conventional X-ray angiography or scintigraphy. We have applied this method to several clinical applications such as breast cancer sentinel lymph node (SLN) navigation, lymph edema diagnostic and identification of liver segmentation. In each application, ICG fluorescence method shows useful result. It's indicated that this method is promising technique as optical angiography.

  4. Multiphase Systems for Medical Image Region Classification

    NASA Astrophysics Data System (ADS)

    Garamendi, J. F.; Malpica, N.; Schiavi, E.

    2009-05-01

    Variational methods for region classification have shown very promising results in medical image analysis. The Chan-Vese model is one of the most popular methods, but its numerical resolution is slow and it has serious drawbacks for most multiphase applications. In this work, we extend the link, stablished by Chambolle, between the two classes binary Chan-Vese model and the Rudin-Osher-Fatemi (ROF) model to a multiphase four classes minimal partition problem. We solve the ROF image restoration model and then we threshold the image by means of a genetic algorithm. This strategy allows for a more efficient algorithm due to the fact that only one well posed elliptic problem is solved instead of solving the coupled parabolic equations arising in the original multiphase Chan-Vese model.

  5. The quest for standards in medical imaging.

    PubMed

    Gibaud, Bernard

    2011-05-01

    This article focuses on standards supporting interoperability and system integration in the medical imaging domain. We introduce the basic concepts and actors and we review the most salient achievements in this domain, especially with the DICOM standard, and the definition of IHE integration profiles. We analyze and discuss what was successful, and what could still be more widely adopted by industry. We then sketch out a perspective of what should be done next, based on our vision of new requirements for the next decade. In particular, we discuss the challenges of a more explicit sharing of image and image processing semantics, and we discuss the help that semantic web technologies (and especially ontologies) may bring to achieving this goal.

  6. Survey: interpolation methods in medical image processing.

    PubMed

    Lehmann, T M; Gönner, C; Spitzer, K

    1999-11-01

    Image interpolation techniques often are required in medical imaging for image generation (e.g., discrete back projection for inverse Radon transform) and processing such as compression or resampling. Since the ideal interpolation function spatially is unlimited, several interpolation kernels of finite size have been introduced. This paper compares 1) truncated and windowed sinc; 2) nearest neighbor; 3) linear; 4) quadratic; 5) cubic B-spline; 6) cubic; g) Lagrange; and 7) Gaussian interpolation and approximation techniques with kernel sizes from 1 x 1 up to 8 x 8. The comparison is done by: 1) spatial and Fourier analyses; 2) computational complexity as well as runtime evaluations; and 3) qualitative and quantitative interpolation error determinations for particular interpolation tasks which were taken from common situations in medical image processing. For local and Fourier analyses, a standardized notation is introduced and fundamental properties of interpolators are derived. Successful methods should be direct current (DC)-constant and interpolators rather than DC-inconstant or approximators. Each method's parameters are tuned with respect to those properties. This results in three novel kernels, which are introduced in this paper and proven to be within the best choices for medical image interpolation: the 6 x 6 Blackman-Harris windowed sinc interpolator, and the C2-continuous cubic kernels with N = 6 and N = 8 supporting points. For quantitative error evaluations, a set of 50 direct digital X rays was used. They have been selected arbitrarily from clinical routine. In general, large kernel sizes were found to be superior to small interpolation masks. Except for truncated sinc interpolators, all kernels with N = 6 or larger sizes perform significantly better than N = 2 or N = 3 point methods (p < 0.005). However, the differences within the group of large-sized kernels were not significant. Summarizing the results, the cubic 6 x 6 interpolator with continuous

  7. 76 FR 29006 - In the Matter of Certain Motion-Sensitive Sound Effects Devices and Image Display Devices and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-19

    ... COMMISSION Inv. No. 337-TA-773 In the Matter of Certain Motion-Sensitive Sound Effects Devices and Image... of certain motion-sensitive sound effects devices and image display devices and components and... importation of certain motion- sensitive sound effects devices and image display devices and components...

  8. Blind forensics in medical imaging based on Tchebichef image moments.

    PubMed

    Huang, H; Coatrieux, G; Shu, H Z; Luo, L M; Roux, Ch

    2011-01-01

    In this paper, we present a blind forensic approach for the detection of global image modifications like filtering, lossy compression, scaling and so on. It is based on a new set of image features we proposed, called Histogram statistics of Reorganized Block-based Tchebichef moments (HRBT) features, and which are used as input of a set of classifiers we learned to discriminate tampered images from original ones. In this article, we compare the performances of our features with others proposed schemes from the literature in application to different medical image modalities (MRI, X-Ray …). Experimental results show that our HRBT features perform well and in some cases better than other features.

  9. 77 FR 38177 - TRICARE; Off-Label Uses of Devices; Partial List of Examples of Unproven Drugs, Devices, Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-27

    ... Examples of Unproven Drugs, Devices, Medical Treatments, or Procedures AGENCY: Office of the Secretary... rule to revise the definition of ``unlabeled or off-label drug'' to ``off-label use of a drug or device... demonstrations from medical literature, national organizations, or technology assessment bodies that the...

  10. Practical pathology perspectives for minimally invasive hyperthermic medical devices

    NASA Astrophysics Data System (ADS)

    Coad, James E.

    2011-03-01

    Currently, hyperthermic-based minimally invasive medical devices are available for the treatment of dysfunctional and neoplastic tissues in a variety of organ systems. These therapies employ a spectrum of modalities for delivering heat energy to the targeted tissue, including radiofrequency/microwave, high intensity focused ultrasound, conductive/convective sources and others. While differences in energy transfer and organ systems exist, hyperthermic treatment sites show a spectrum of changes that intimately correlate with the thermal history generated in the tissue (temperature-time dependence). As a result, these hyperthermic medical technologies can be viewed using a "gradient" approach. First, the thermal applications themselves can be globally categorized along a high-dose ablation to low-dose ablation to lowdose non-ablative rejuvenating slope. Second, the resultant tissue changes can be viewed along a decreasing thermal dose gradient from thermally/heat-fixed tissue necrosis to coagulative tissue necrosis to partial tissue necrosis (transition zone) to subtle non-necrotizing tissue changes. Finally, a gradient of cellular and structural protein denaturation is present, especially within the transition zone and adjacent viable tissue region. A hyperthermic treatment's location along these gradients depends more on the overall thermal history it generates than the amount of energy it deposits into the tissue. The features of these gradients are highlighted to provide a better understanding of hyperthermic device associated tissue changes and their associated healing responses.

  11. Thermally Stable and Sterilizable Polymer Transistors for Reusable Medical Devices.

    PubMed

    Kyaw, Aung Ko Ko; Jamalullah, Feroz; Vaithieswari, Loga; Tan, Mein Jin; Zhang, Lian; Zhang, Jie

    2016-04-20

    We realize a thermally stable polymer thin film transistor (TFT) that is able to endure the standard autoclave sterilization for reusable medical devices. A thermally stable semiconducting polymer poly[4-(4,4-dihexadecyl-4Hcyclopenta[1,2-b:5,4-b]dithiophen-2-yl)-alt[1,2,5]thiadiazolo [3,4c] pyridine], which is stable up to 350 °C in N2 and 200 °C in air, is used as channel layer, whereas the biocompatible SU-8 polymer is used as a flexible dielectric layer, in addition to conventional SiO2 dielectric layer. Encapsulating with in-house designed composite film laminates as moisture barrier, both TFTs using either SiO2 or SU-8 dielectric layer exhibit good stability in sterilized conditions without significant change in mobility and threshold voltage. After sterilization for 30 min in autoclave, the mobility drops only 15%; from as-fabricated mobility of 1.4 and 1.3 cm(2) V(-1) s(-1) to 1.2 and 1.1 cm(2) V(-1) s(-1) for TFTs with SiO2 and SU-8 dielectric layer, respectively. Our TFT design along with experimental results reveal the opportunity on organic/polymer flexible TFTs in sterilizable/reusable medical device application.

  12. Lossless wavelet compression on medical image

    NASA Astrophysics Data System (ADS)

    Zhao, Xiuying; Wei, Jingyuan; Zhai, Linpei; Liu, Hong

    2006-09-01

    An increasing number of medical imagery is created directly in digital form. Such as Clinical image Archiving and Communication Systems (PACS), as well as telemedicine networks require the storage and transmission of this huge amount of medical image data. Efficient compression of these data is crucial. Several lossless and lossy techniques for the compression of the data have been proposed. Lossless techniques allow exact reconstruction of the original imagery, while lossy techniques aim to achieve high compression ratios by allowing some acceptable degradation in the image. Lossless compression does not degrade the image, thus facilitating accurate diagnosis, of course at the expense of higher bit rates, i.e. lower compression ratios. Various methods both for lossy (irreversible) and lossless (reversible) image compression are proposed in the literature. The recent advances in the lossy compression techniques include different methods such as vector quantization. Wavelet coding, neural networks, and fractal coding. Although these methods can achieve high compression ratios (of the order 50:1, or even more), they do not allow reconstructing exactly the original version of the input data. Lossless compression techniques permit the perfect reconstruction of the original image, but the achievable compression ratios are only of the order 2:1, up to 4:1. In our paper, we use a kind of lifting scheme to generate truly loss-less non-linear integer-to-integer wavelet transforms. At the same time, we exploit the coding algorithm producing an embedded code has the property that the bits in the bit stream are generated in order of importance, so that all the low rate codes are included at the beginning of the bit stream. Typically, the encoding process stops when the target bit rate is met. Similarly, the decoder can interrupt the decoding process at any point in the bit stream, and still reconstruct the image. Therefore, a compression scheme generating an embedded code can

  13. A balancing act: a phenomenological exploration of medical students' experiences of using mobile devices in the clinical setting

    PubMed Central

    Rashid-Doubell, F; Mohamed, S; Elmusharaf, K; O'Neill, C S

    2016-01-01

    Objective The aims of this study were to describe the experiences of senior students using mobile devices in a clinical setting while learning and interacting with clinical teachers, patients and each other, and to identify challenges that facilitated or impeded the use of such devices in the hospital. Design Interpretative phenomenology was chosen to guide our enquiry. Semi-structured interviews were conducted to examine the experiences of five senior medical students using mobile devices in the clinical setting. Setting and participants Senior medical students at an international medical school in the Middle East. Results Three main themes emerged from the data analysis: learning; professional identity and transitioning from student to doctor. The findings showed that using mobile devices in the clinical area as a learning tool was not a formalised process. Rather, it was opportunistic learning at the bedside and on occasion a source of distraction from clinical teaching. Students needed to negotiate relationships between themselves, the clinical teacher and patients in order to ensure that they maintained an acceptable professional image. Participants experienced and negotiated the change from student to doctor making them mindful of using their devices at the bedside. Conclusions Mobile devices are part of daily life for a medical student and there is a need to adapt medical education in the clinical setting, to allow the students to use their devices in a sensitive manner. PMID:27142860

  14. Live minimal path for interactive segmentation of medical images

    NASA Astrophysics Data System (ADS)

    Chartrand, Gabriel; Tang, An; Chav, Ramnada; Cresson, Thierry; Chantrel, Steeve; De Guise, Jacques A.

    2015-03-01

    Medical image segmentation is nowadays required for medical device development and in a growing number of clinical and research applications. Since dedicated automatic segmentation methods are not always available, generic and efficient interactive tools can alleviate the burden of manual segmentation. In this paper we propose an interactive segmentation tool based on image warping and minimal path segmentation that is efficient for a wide variety of segmentation tasks. While the user roughly delineates the desired organs boundary, a narrow band along the cursors path is straightened, providing an ideal subspace for feature aligned filtering and minimal path algorithm. Once the segmentation is performed on the narrow band, the path is warped back onto the original image, precisely delineating the desired structure. This tool was found to have a highly intuitive dynamic behavior. It is especially efficient against misleading edges and required only coarse interaction from the user to achieve good precision. The proposed segmentation method was tested for 10 difficult liver segmentations on CT and MRI images, and the resulting 2D overlap Dice coefficient was 99% on average..

  15. Surgical hemostatic agents: assessment of drugs and medical devices.

    PubMed

    Aubourg, R; Putzolu, J; Bouche, S; Galmiche, H; Denis, C; d'Andon, A; Maitrot, D; Partensky, C

    2011-12-01

    Surgical hemostatic agents are indicated to improve hemostasis when conventional techniques (compression, sutures or electrocoagulation) are inadequate. The National French Authority for Health (Haute Autorité de santé [HAS]) set out to assess these products (medical devices and agents) to determine their optimal utility. This evaluation included one class of products containing some form of human fibrinogen and thrombin and eight classes of medical devices and automated devices to prepare autologous fibrin. The assessment was based on a systematic review of the literature and expert opinion of health care professionals. The main measures of effectiveness of hemostatic agents were the success rate as expressed in terms of the time necessary to obtain adequate hemostasis, the volume of intra and/or postoperative blood loss, the need for blood transfusions, complication rate, duration of operations and hospital stay. A meta-analysis and 52 controlled randomized studies were selected involving cardiac or vascular surgery (19), ENT surgery (11), gastrointestinal surgery (5), urology (4), orthopedic surgery (4). Approximately half of the studies retained in this analysis evaluated blood derived agents (fibrin sealants) while the other half evaluated medical devices. The working group considered that there is not any evidence that these surgical hemostatic agents decrease the rates of transfusion, complications, reoperation, mortality, duration of operation and/or hospital stay. The working group considered that the use of surgical hemostatic agents to improve the safety of hemostasis in the absence of identified bleeding as an alternative to adequate conventional hemostasis was not justified. Surgical hemostatic agents can be used in ad hoc settings, as a complement to conventional methods to control persistent bleeding after conventional hemostatic techniques, or when abundant bleeding has led to biologic hemostatic disorders. The working group also distinguished

  16. Integrating the results of user research into medical device development: insights from a case study

    PubMed Central

    2012-01-01

    Background It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. Methods A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. Results A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. Conclusion There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision making processes may assist

  17. Medical image archive node simulation and architecture

    NASA Astrophysics Data System (ADS)

    Chiang, Ted T.; Tang, Yau-Kuo

    1996-05-01

    It is a well known fact that managed care and new treatment technologies are revolutionizing the health care provider world. Community Health Information Network and Computer-based Patient Record projects are underway throughout the United States. More and more hospitals are installing digital, `filmless' radiology (and other imagery) systems. They generate a staggering amount of information around the clock. For example, a typical 500-bed hospital might accumulate more than 5 terabytes of image data in a period of 30 years for conventional x-ray images and digital images such as Magnetic Resonance Imaging and Computer Tomography images. With several hospitals contributing to the archive, the storage required will be in the hundreds of terabytes. Systems for reliable, secure, and inexpensive storage and retrieval of digital medical information do not exist today. In this paper, we present a Medical Image Archive and Distribution Service (MIADS) concept. MIADS is a system shared by individual and community hospitals, laboratories, and doctors' offices that need to store and retrieve medical images. Due to the large volume and complexity of the data, as well as the diversified user access requirement, implementation of the MIADS will be a complex procedure. One of the key challenges to implementing a MIADS is to select a cost-effective, scalable system architecture to meet the ingest/retrieval performance requirements. We have performed an in-depth system engineering study, and developed a sophisticated simulation model to address this key challenge. This paper describes the overall system architecture based on our system engineering study and simulation results. In particular, we will emphasize system scalability and upgradability issues. Furthermore, we will discuss our simulation results in detail. The simulations study the ingest/retrieval performance requirements based on different system configurations and architectures for variables such as workload, tape

  18. The FDA's role in medical device clinical studies of human subjects

    NASA Astrophysics Data System (ADS)

    Saviola, James

    2005-03-01

    This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

  19. X-ray detectors in medical imaging

    NASA Astrophysics Data System (ADS)

    Spahn, Martin

    2013-12-01

    Healthcare systems are subject to continuous adaptation, following trends such as the change of demographic structures, the rise of life-style related and chronic diseases, and the need for efficient and outcome-oriented procedures. This also influences the design of new imaging systems as well as their components. The applications of X-ray imaging in the medical field are manifold and have led to dedicated modalities supporting specific imaging requirements, for example in computed tomography (CT), radiography, angiography, surgery or mammography, delivering projection or volumetric imaging data. Depending on the clinical needs, some X-ray systems enable diagnostic imaging while others support interventional procedures. X-ray detector design requirements for the different medical applications can vary strongly with respect to size and shape, spatial resolution, frame rates and X-ray flux, among others. Today, integrating X-ray detectors are in common use. They are predominantly based on scintillators (e.g. CsI or Gd2O2S) and arrays of photodiodes made from crystalline silicon (Si) or amorphous silicon (a-Si) or they employ semiconductors (e.g. Se) with active a-Si readout matrices. Ongoing and future developments of X-ray detectors will include optimization of current state-of-the-art integrating detectors in terms of performance and cost, will enable the usage of large size CMOS-based detectors, and may facilitate photon counting techniques with the potential to further enhance performance characteristics and foster the prospect of new clinical applications.

  20. [Tattoos and medical imaging: issues and myths].

    PubMed

    Kluger, Nicolas

    2014-05-01

    Tattooing is characterized by the introduction in the dermis of exogenous pigments to obtain a permanent design. Whether it is a traditional tattoo applied on the skin or a cosmetic one (permanent make-up), its prevalence has boomed for the past 20 years. The increased prevalence of tattooed patients along with medical progresses, in the field of therapeutics or diagnostic means have lead to the discovery of "new" complications and unexpected issues. Medical imaging world has also been affected by the tattoo craze. It has been approximately 20 years when the first issues related to tattooing and permanent make-up aroused. However, cautions and questions as well as anecdotal severe case reports have sometimes led to an over-exaggerated response by some physicians such as the systematic avoidance of RMN imaging for tattooed individuals. This review is intended to summarize the risks but also the "myths" associated with tattoo in the daily practice of the radiologist for RMN, CT scan, mammography, Pet-scan and ultrasound imaging.