Results 11 to 20 of about 9,793,032 (331)

Medical Device Regulation: Should We Care About It?

open access: yesArtery Research, 2022
Medical devices are subject to strict regulatory and approval processes to enter the market and to be used by operators and patients. These are needed to guarantee the users’ safety. The different activities of these processes have important implications
E. Bianchini, C. Mayer
semanticscholar   +1 more source

Microscale Sensor Fabrication on Curved Needle Surfaces

open access: yesCurrent Directions in Biomedical Engineering, 2022
Sensor-integrated needles with impedance or other electrochemical sensors have gained increased attention in research. Their potential use is widespread and covers applications such as early disease diagnostics or needle guidance for needle-based ...
Liu Jan   +4 more
doaj   +1 more source

Practice Issues for Evaluation and Management of the Suicidal Left Ventricular Assist Device Patient [PDF]

open access: yes, 2020
There is a high prevalence of depression among left ventricular assist device patients, who present with an increased risk of suicidality given access to means via the device either with nonadherence or disconnection.
Chernyak, Yelena   +3 more
core   +1 more source

Practice toward standardized performance testing of computer-aided detection algorithms for pulmonary nodule

open access: yesFrontiers in Public Health, 2022
This study aimed at implementing practice to build a standardized protocol to test the performance of computer-aided detection (CAD) algorithms for pulmonary nodules.
Hao Wang   +5 more
doaj   +1 more source

Medical Device Sterilization and Reprocessing in the Era of Multidrug-Resistant (MDR) Bacteria: Issues and Regulatory Concepts

open access: yesFrontiers in Medical Technology, 2021
The emergence of multidrug-resistant (MDR) bacteria threatens humans in various health sectors, including medical devices. Since formal classifications for medical device sterilization and disinfection were established in the 1970's, microbial adaptation
Jonathan Josephs-Spaulding, O. Singh
semanticscholar   +1 more source

Simulation and Experimental Investigation of a Hollow, Bipolar Needle Electrode

open access: yesCurrent Directions in Biomedical Engineering, 2021
Localized impedance measurements at the needle tip identifying the present tissue type could aid clinicians in needle procedures. To assess the sensitivity field of a hollow, bipolar needle electrode, a 3D finite element approach using COMSOL ...
Liu Jan   +4 more
doaj   +1 more source

Regulatory considerations for animal studies of biomaterial products

open access: yesBioactive Materials, 2022
Animal studies play a vital role in validating the concept, feasibility, safety, performance and efficacy of biomaterials products during their bench-to-clinic translation.
Maobo Cheng   +12 more
doaj   +1 more source

A review of medical device regulations in India, comparison with European Union and way-ahead

open access: yesPerspectives in Clinical Research, 2021
Indian healthcare sector is a fast-growing industry which is expected to reach $280 billion by 2025. Medical devices market in India is one of the top 20 medical device markets in the world. It is currently valued at $5.2 billion and is expected to reach
Manas Manu, G. Anand
semanticscholar   +1 more source

Robotic Scrub Nurse: Surgical Instrument Handling with a Granular Jamming Gripper

open access: yesCurrent Directions in Biomedical Engineering, 2023
The global shortage of healthcare staff has led to high workloads and subsequent risks to patient well-being. One of the professions affected is that of the scrub nurse.
Schäfer Max B.   +5 more
doaj   +1 more source

User involvement in healthcare technology development and assessment: Structured literature review [PDF]

open access: yes, 2006
Purpose – Medical device users are one of the principal stakeholders of medical device technologies. User involvement in medical device technology development and assessment is central to meet their needs.
Robinson, I, Shah, SGS
core   +1 more source

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