Abstract
BackgroundArtificial intelligence (AI) technology has developed rapidly in recent years, leading to exponential growth in the AI medical industry. However, a comprehensive investigation of approved medical devices in China is needed. MethodsWe utilized a web crawler to collect data on all medical devices from the China National Medical Products Administration website since 2018. Through natural language processing techniques and manual analysis, we identified all medical devices developed by artificial intelligence medical devices (AIMD) companies and conducted a statistical analysis. ResultsSince 2018, the number of AI-related medical devices approved in China has significantly increased. Most devices (79 %) were classified as Class II with moderate risk, whereas 21 % were classified as Class III with high risk. Most devices (74.2 %) were categorized as medical device software, and the most common application was medical image processing (63.2 %). In terms of target body areas, devices related to the heart accounted for the highest proportion (12.8 %), followed by those related to the lungs (11.3 %) and brain (6.7 %). ConclusionThis study establishes a comprehensive database of medical devices developed by AIMD companies in China, enabling the public to gain a coherent understanding of their current development status.
Published Version
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