The U.S. Food and Drug Administration maintains a public list of AI- and machine-learning-enabled medical devices authorized for marketing in the United States, identified from AI-related terms in their authorization documents. A 2025 peer-reviewed analysis in Biomedicines, “Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024,” drew on that database and reported that the FDA had authorized 692 AI/ML-enabled devices by the end of 2023.
The same study found the FDA authorized 168 such devices in 2024, of which 125 - about 74 percent - were radiology devices. Radiology has dominated the list for years, because medical imaging produces large, well-labeled datasets and the diagnostic task maps cleanly onto the pattern-recognition strengths of deep learning. The running total has continued to climb past 1,000 devices, making AI-enabled software one of the most active categories in medical-device authorization, even though the great majority of these tools assist clinicians rather than act autonomously.