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FDA Regulation and Approval of Medical Devices: 1976-2020
JAMA - Journal of the American Medical Association, 2021Importance US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks.
Jonathan J Darrow
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Wearable, Implantable, and Interventional Medical Devices Based on Smart Electronic Skins
Advanced Materials Technologies, 2021Recent advances in soft, flexible, and stretchable sensors have offered a good opportunity to design various types of wearable flexible medical devices for achievement of continuous health monitoring, preventive medicine and robot feedback and control ...
Lili Wang, Guozhen Shen
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Medical devices: US medical device regulation
Urologic Oncology: Seminars and Original Investigations, 2015Medical 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 ...
Jonathan P Jarow
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IEEE Communications Surveys and Tutorials, 2019
Over the last few years, healthcare administrations have been digitizing their provision of care that led to an increased number of networked medical devices and medical telemetry. Due to such digitization, medical devices have made phenomenal strides in
Haider Abbas, Mohammed Atiquzzaman
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Over the last few years, healthcare administrations have been digitizing their provision of care that led to an increased number of networked medical devices and medical telemetry. Due to such digitization, medical devices have made phenomenal strides in
Haider Abbas, Mohammed Atiquzzaman
exaly +2 more sources
A Review of Bioresorbable Implantable Medical Devices: Materials, Fabrication, and Implementation
Advanced Healthcare Materials, 2020Implantable medical devices (IMDs) are designed to sense specific parameters or stimulate organs and have been actively used for treatment and diagnosis of various diseases.
Emin Istif, Levent Beker
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Recent Advances in Intelligent Wearable Medical Devices Integrating Biosensing and Drug Delivery
Advances in Materials, 2022The primary roles of precision medicine are to perform real‐time examination, administer on‐demand medication, and apply instruments continuously. However, most current therapeutic systems implement these processes separately, leading to treatment ...
Min-hong Tan +7 more
semanticscholar +1 more source
Int. J. Medical Informatics, 2022
BACKGROUND Machine learning (ML), a type of artificial intelligence (AI) technology that uses a data-driven approach for pattern recognition, has been shown to be beneficial for many tasks across healthcare. To characterize the commercial availability of
Simeng Zhu +3 more
semanticscholar +1 more source
BACKGROUND Machine learning (ML), a type of artificial intelligence (AI) technology that uses a data-driven approach for pattern recognition, has been shown to be beneficial for many tasks across healthcare. To characterize the commercial availability of
Simeng Zhu +3 more
semanticscholar +1 more source
Emerging 4D Printing Strategies for Next‐Generation Tissue Regeneration and Medical Devices
Advances in Materials, 2021The rapid development of 3D printing has led to considerable progress in the field of biomedical engineering. Notably, 4D printing provides a potential strategy to achieve a time‐dependent physical change within tissue scaffolds or replicate the dynamic ...
Yue Wang +5 more
semanticscholar +1 more source
Materials Used in Medical Devices
Plastics in Medical Devices, 2022Materials like metal, wood, ceramics, glass, and plastics are used in many medical device applications. Surgical instruments have been manufactured since the dawn of humankind.
Vinny R. Sastri
semanticscholar +1 more source
Achieving fairness in medical devices
Science, 2021Learning from computer science can make medical devices fair for all races and sexes The hardware or software that operates medical devices can be biased.
Achuta Kadambi
semanticscholar +1 more source