FDA AI Device Tracker
Every FDA-authorized AI medical device, tracked weekly
FDA's official AI-enabled device list, plus the newer 510(k) clearances it has not caught up with yet. Updated every week by MedAI Signal.
1,659AI-enabled devices
226decided in 2026
48in the last 90 days
45newer than FDA's list (2026-06-29)
Authorizations per year
By review panel
- Radiology1274
- Cardiovascular154
- Neurology73
- Anesthesiology30
- Gastroenterology-Urology27
- Hematology22
- Ophthalmic11
- Pathology10
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| Date | Device | Panel | Pathway |
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