China Records Rising AI Medical Device Approvals

Researchers analyzed Drugdataexpy and NMPA records to identify AI-based medical devices approved in China through June 30, 2025, finding 154 approvals since 2020. Approvals rose from 9 in 2020 to 45 in 2024, with 79.9% classified as class III and deep learning and radiology (CT) dominating; clinical trials were the primary evaluation pathway. The study highlights market concentration among a few manufacturers in major Chinese hubs.
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