Data-Driven Analysis of AI in Medical Device Software in China: Deep Learning and General AI Trends Based on Regulatory Data
This provides the first extensive analysis of AI in medical devices in China, aiding regulators and the medical community in tracking trends, though it is incremental as it applies existing methods to new data.
The study analyzed AI-enabled medical devices in China using a data-driven approach on regulatory data, identifying 43 AI-enabled devices out of 2,174 registrations and finding respiratory, ophthalmology/endocrinology, and orthopedics as leading specialties.
Artificial intelligence (AI) in medical device software (MDSW) represents a transformative clinical technology, attracting increasing attention within both the medical community and the regulators. In this study, we leverage a data-driven approach to automatically extract and analyze AI-enabled medical devices (AIMD) from the National Medical Products Administration (NMPA) regulatory database. The continued increase in publicly available regulatory data requires scalable methods for analysis. Automation of regulatory information screening is essential to create reproducible insights that can be quickly updated in an ever changing medical device landscape. More than 4 million entries were assessed, identifying 2,174 MDSW registrations, including 531 standalone applications and 1,643 integrated within medical devices, of which 43 were AI-enabled. It was shown that the leading medical specialties utilizing AIMD include respiratory (20.5%), ophthalmology/endocrinology (12.8%), and orthopedics (10.3%). This approach greatly improves the speed of data extracting providing a greater ability to compare and contrast. This study provides the first extensive, data-driven exploration of AIMD in China, showcasing the potential of automated regulatory data analysis in understanding and advancing the landscape of AI in medical technology.