Results 281 to 290 of about 9,793,032 (331)

Exploring Impediments Imposed by the Medical Device Regulation EU 2017/745 on Software as a Medical Device.

JMIR Med Inform
Svempe L.
europepmc   +1 more source

Artificial intelligence as a medical device for ophthalmic image analysis: a scoping review of regulated devices

Ong AY, Taribagil P, Sevgi M, Kale AU, Dow ER, Macdonald T, Kras A, Maniatopoulos G, Liu X, Keane PA, Denniston AK, Hogg HDJ.   +11 more
europepmc   +1 more source

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Contemporary medical, device, and surgical therapies for obesity in adults

The Lancet, 2023
The goal of obesity management is to improve health. Sustained weight loss of more than 10% overall bodyweight improves many of the complications associated with obesity (eg, prevention and control of type 2 diabetes, hypertension, fatty liver disease ...
C. Perdomo, R. Cohen, P. Sumithran, Karine Clément, G. Frühbeck   +4 more
semanticscholar   +1 more source

The New European Medical Device Regulation: Balancing Innovation and Patient Safety

Annals of Internal Medicine, 2023
The European Union has introduced stricter provisions for medical devices under the new Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing for many devices before they can legally be placed on the market and ...
M. Bretthauer, S. Gerke, C. Hassan, Omer F. Ahmad, Yuichi Mori   +4 more
semanticscholar   +1 more source

Risk factors of medical device-related pressure injury in intensive care units.

Journal of Clinical Nursing, 2021
OBJECTIVES Intensive care unit (ICU) patients are at high risk of medical device related pressure injury (MDRPI). This study aims to ascertain the MDRPI prevalence in ICU patients and analyse the risk factors of MDRPI.
W. Dang, Yuan Liu, Qing Zhou, Yuyu Duan, H. Gan, Lin Wang, Qiongli Zhu, C. Xie, A. Hu   +8 more
semanticscholar   +1 more source

Medical devices: US medical device regulation

Urologic Oncology: Seminars and Original Investigations, 2015
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 ...
Jonathan P, Jarow, John H, Baxley
openaire   +2 more sources

Medical device research

Expert Review of Medical Devices, 2005
This perspective provides a commentary on the quality of life improvements made available from advances in medical device technology. An opinion of the elements necessary to bring innovation into medical device research is offered. In order to enhance the output of medical device research, strong interactive links are needed between clinicians and ...
Boyle, Justin, Maeder, Anthony, Bell, John, John, Sabu, Scott, Robin   +4 more
openaire   +3 more sources