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PubMed

Approval of AI-Based Medical Devices in China From 2020 to 2025: Retrospective Analysis.

PMID: 41849560 · 2026

JournalJMIR medical informatics
Year2026
PMID41849560

Abstract

Artificial intelligence-based medical devices (AIMDs) have emerged as transformative technologies in modern health care. However, comprehensive analysis of recent approval trends and characteristics of AIMDs in China remains limited. This study aimed to provide an up-to-date overview of AIMDs approved in China up to June 2025. We conducted a search of the Drugdataexpy database to identify AIMDs approved up to June 30, 2025, using artificial intelligence-related keywords in the "structural compos

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