Every FDA-cleared AI
medical device, searchable.
The FDA lists 1,614 AI-enabled medical devices from 653 companies across 18 specialties. 1,230 of them (76%) are in radiology. Search, filter and track them all.
1,614AI-enabled devices1995–2026
653Companies
335Authorized in 2025+42.6% vs 2024
181In 2026 so farthrough 2026-06-29
AI device authorizations per year
2026 is partial (through 2026-06-29).
'95'01'05'10'13'16'19'22'25'26
By specialty (lead panel)
Recently authorized
- Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)Agada Medical, Ltd. · Radiology
- ADAS 3DAdas3D Medical S.L. · Radiology
- Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- SOMNUM (SOMNUM)Honeynaps Co., Ltd. · Neurology
- MammoScreen® (5)Therapixel · Radiology
- syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · Radiology
- Enhanced Boundary for PCCTGe Medical Systems, LLC · Radiology
- RX-1 SleepVivaquant, Inc. Dba Rhythm Express · Anesthesiology
Guides
By year
Clearances from 2016 to 2026
11 years with at least 10 FDA AI decisions, plus the specialties inside each year.
RoundupsTop AI devices by specialty
6 specialties ranked by how many FDA clearances each company holds, not by clinical claims.
Head to headSiemens Medical Solutions USA and 28 matchups
The 8 companies with the most AI devices, compared as separate FDA applicants.
AI Device Radar Weekly
New FDA AI clearances, every week
A short email when a new issue is published: the devices the FDA just decided, the companies behind them, and what changed in the counts. Read the archive.