Data-Driven Analysis of AI in Medical Device Software in China: Trends of Deep Learning and Traditional AI Based on Regulatory Data

TL;DR

This study uses automated analysis of regulatory data to explore the landscape of AI-enabled medical device software in China, revealing trends and specialties utilizing AI technologies.

Contribution

It introduces a scalable, automated method for analyzing regulatory data to understand AI adoption in Chinese medical device software.

Findings

Identified 43 AI-enabled medical device software entries in China.

Highlighted key medical specialties using AI, such as respiratory and ophthalmology.

Demonstrated the effectiveness of automated data extraction for regulatory analysis.

Abstract

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.