FDA AI medical device clearances in 2025
2025 has 335 AI devices, 42.6% more than 2024 (235). They come from 224 companies. Radiology accounted for 254 (75.8%). The newest decision was TruSPECT Processing Station from Spectrum Dynamics Medical, Ltd. on December 30, 2025.
By specialty
Top companies
Decisions by month
Pathways
510(k): 329 (98.2%) · PMA: 4 (1.2%) · De Novo: 2 (0.6%). The first decision in 2025 was Ezra Flash (January 2, 2025).
Companies with a first AI clearance in 2025
108 companies have their earliest device on this list dated 2025. The busiest of those first-timers is Artrya Limited, with 2 decisions in 2025. Showing 8 of 108.
Newest decisions in 2025
- TruSPECT Processing StationSpectrum Dynamics Medical, Ltd. · Radiology
- AIR Recon DLGe Medical Systems, LLC · Radiology
- ART-Plan+ (v3.1.0)Therapanacea Sas · Radiology
- PeekMed webPeek Health, S.A. · Radiology
- SKOUT systemIterative Health · Gastroenterology-Urology
- BioticsAIBioticsai, Inc. · Radiology
- Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- AlzevitaTOPIA MEDTECH LIMITED · Radiology
- eMurmur Heart AICsd Labs · Cardiovascular
- MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.RiseSiemens Healthcare GmbH · Radiology
- AI-CVDHeartLung Corporation · Radiology
- MediAI-BACrescom Co., Ltd. · Radiology
The full 2025 set is split by specialty above. Radiology in 2025 · Cardiovascular in 2025 · Neurology in 2025 · Anesthesiology in 2025
Frequently asked questions
How many AI medical devices did the FDA authorize in 2025?
The FDA list has 335 AI-enabled devices with a final decision dated 2025, from 224 companies.
Which specialty had the most AI clearances in 2025?
Radiology led with 254 devices, 75.8% of 2025.
Which company had the most FDA AI devices in 2025?
GE Medical Systems Ultrasound and Primary Care Diagnostics had the most, with 10. Next: Shanghai United Imaging Healthcare Co., Ltd. (10), Philips Ultrasound, LLC (9).
How did 2025 compare with 2024?
2025 has 335 AI devices, 42.6% more than 2024 (235).
How many companies received their first AI-device decision in 2025?
108 companies have their earliest AI-device decision dated 2025.
Cite as: AI Device Radar, “FDA AI medical device clearances in 2025,” https://ai-device-radar.vercel.app/year/2025 (FDA list through 2026-06-29).