The FDA last week released the long-awaited update to its list of AI-enabled medical devices that have received marketing authorization. The closely watched list shows the number of AI-enabled radiology authorizations approaching the 1k mark.
The FDA has been tracking authorizations of AI-enabled devices going back to 1995, and the list gives industry watchers a feel for not only how quickly the agency is churning out reviews but also which medical specialties are generating the most approvals.
- But the last time the FDA released an updated list was August 2024, and recent turmoil at the agency had some observers wondering if it would continue the tradition – as well as whether it could stay on pace for new approvals.
Those fears should be assuaged with the new release. The numbers indicate that through May 2025 the FDA has…
- Granted authorization to 1.2k AI-enabled medical devices since it started tracking.
- Approved 956 AI-enabled radiology products, or 77% of total medical authorizations.
- Radiology’s share of overall authorizations from January to May 2025 ticked up to 78% (115/148), compared to 73% in the 2024 update, and 80% in all of 2023.
- GE HealthCare remains the company with the most radiology AI authorizations, at 96 (including recent acquisitions like Caption Health and MIM Software), with Siemens Healthineers in second place at 80 (including Varian).
- Other notable mentions include Philips (42 including DiA Analysis), Canon (35), United Imaging (32), and Aidoc (30).
In a significant regulatory development, the FDA said it was developing a plan to identify and tag medical devices that use foundation models, including large language models and multimodal architecture.
- The agency said the program would help healthcare providers and patients know when LLM-based functionality was included in a medical device (the FDA has yet to approve a medical device with LLM technology).
In another interesting change, the FDA dropped “machine learning” from the title of its list, apparently with the idea that “AI” was sufficient as an umbrella term.
The Takeaway
The FDA’s release of its AI approval list is a welcome return to past practices that should reassure agency watchers that recent turmoil isn’t affecting its basic operations. The LLM guidance suggests the agency may be changing its approach to the technology in favor of disclosure and transparency instead of more stringent regulation that could delay some LLM solutions from reaching the market.
