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Tytuł pozycji:

Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20): a comparative analysis.

Tytuł :
Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20): a comparative analysis.
Autorzy :
Muehlematter UJ; Institute of Diagnostic and Interventional Radiology, University Hospital Zurich, University of Zurich, Switzerland.
Daniore P; Institute of Law, University of Zurich, Switzerland.
Vokinger KN; Institute of Law, University of Zurich, Switzerland. Electronic address: .
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Źródło :
The Lancet. Digital health [Lancet Digit Health] 2021 Mar; Vol. 3 (3), pp. e195-e203. Date of Electronic Publication: 2021 Jan 18.
Typ publikacji :
Comparative Study; Journal Article; Review
Język :
English
Imprint Name(s) :
Original Publication: [Oxford] : Elsevier Ltd., [2019]-
MeSH Terms :
Artificial Intelligence*
Biomedical Technology*
Equipment and Supplies*
Government Regulation*
Machine Learning*
Databases, Factual ; Device Approval ; Europe ; Humans ; Radiology ; United States ; United States Food and Drug Administration
Entry Date(s) :
Date Created: 20210122 Date Completed: 20210317 Latest Revision: 20210317
Update Code :
20210623
DOI :
10.1016/S2589-7500(20)30292-2
PMID :
33478929
Czasopismo naukowe
There has been a surge of interest in artificial intelligence and machine learning (AI/ML)-based medical devices. However, it is poorly understood how and which AI/ML-based medical devices have been approved in the USA and Europe. We searched governmental and non-governmental databases to identify 222 devices approved in the USA and 240 devices in Europe. The number of approved AI/ML-based devices has increased substantially since 2015, with many being approved for use in radiology. However, few were qualified as high-risk devices. Of the 124 AI/ML-based devices commonly approved in the USA and Europe, 80 were first approved in Europe. One possible reason for approval in Europe before the USA might be the potentially relatively less rigorous evaluation of medical devices in Europe. The substantial number of approved devices highlight the need to ensure rigorous regulation of these devices. Currently, there is no specific regulatory pathway for AI/ML-based medical devices in the USA or Europe. We recommend more transparency on how devices are regulated and approved to enable and improve public trust, efficacy, safety, and quality of AI/ML-based medical devices. A comprehensive, publicly accessible database with device details for Conformité Européene (CE)-marked medical devices in Europe and US Food and Drug Administration approved devices is needed.
(Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

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