Radiology dominated FDA authorizations of AI- and machine learning-enabled medical devices through 2025, according to a peer-reviewed study published in Cureus.
The study examined 1,430 authorization records in the FDA’s public AI-enabled device list with authorization dates from September 1995 through December 2025. Here are five things to know:
- Radiology accounted for 76.5% of authorizations. Of the 1,430 authorization records analyzed, 1,094 were in radiology.
- Radiology, cardiovascular and neurology collectively represented 90.6% of authorization records.
- Authorizations accelerated sharply. The annual average increased from 1.8 per year from 1995 through 2014 to 264 per year from 2023 through 2025. There were 331 authorizations in 2025.
- A small group of companies accounted for a sizable share. Among 740 companies, 502 (67.8%) had a single authorized device, while 13 companies (1.8%) accounted for 247 devices (17.3%).
- No authorizations were recorded under the psychiatry or behavioral health review panel. The analysis measured authorization records, not clinical adoption, patient benefit or physician replacement, and the FDA’s AI-enabled device list is not comprehensive.
