A decade of review in global regulation and research of artificial intelligence medical devices (2015–2025)

Artificial intelligence (AI) and medical devices are increasingly integrated, reshaping global diagnostic paradigms. However, the adaptive learning and opaque nature of AI technologies pose significant challenges to traditional regulatory frameworks. In response, regulatory bodies worldwide, includi...

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Bibliographic Details
Main Authors: Siwen Zhang, Yujun Li, Wenxi Liu, Qi Chu, Shasha Wang, Jinyu Li, Yuwen Chen
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-07-01
Series:Frontiers in Medicine
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Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2025.1630408/full
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