China approves more AI medical devices as industry expands into treatment

(ECNS) - China is approving an increasing number of artificial intelligence-powered medical devices as the technology is increasingly expanding beyond diagnostic support into treatment applications, according to industry participants and regulatory data.

Several AI products have received Class III medical device registration certificates from the National Medical Products Administration this year, allowing them to enter the market for high-risk medical applications.

Recent approvals include AI-assisted pathology software, endoscopy systems and surgical navigation robots, reflecting a broader shift toward treatment-oriented technologies rather than diagnostic tools alone.

Industry executives said manufacturers are increasingly integrating AI directly into medical equipment instead of offering standalone software, while expanding into multimodal platforms that combine imaging, electronic medical records and other clinical data.

The sector is also exploring new business models beyond one-time equipment sales, including recurring revenue from consumables, software upgrades and maintenance services, as AI products expand into county-level hospitals and primary healthcare institutions.

(By Zhang Jiahao)