AI in Medical Device Software: Deep Learning Trends in China's NMPA Data
An analytical study focused on AI in medical device software (MDSW) in China, utilizing regulatory information from the National Medical Products Administration (NMPA), uncovers trends in both deep learning and conventional AI. Researchers examined more than 4 million records, discovering 2,174 registrations for MDSW, which comprised 531 standalone applications and 1,643 integrated within devices, with 43 being AI-enabled. Respiratory medicine leads the way in the use of AI-enabled medical devices (AIMD) at 20.5%. The findings underscore the necessity for scalable automation to manage the increasing volume of regulatory data and to generate consistent insights.
Key facts
- Study uses data-driven approach to extract AI-enabled medical devices from NMPA regulatory database.
- Over 4 million entries assessed.
- 2,174 MDSW registrations identified.
- 531 standalone applications and 1,643 integrated within medical devices.
- 43 of the registrations were AI-enabled.
- Leading medical specialty for AIMD is respiratory (20.5%).
- Automation of regulatory information screening is essential.
- Study published on arXiv (2411.07378v3).
Entities
Institutions
- National Medical Products Administration (NMPA)
- arXiv
Locations
- China