AI medical devices
A neutral, evidence-based catalogue. No manufacturer pricing, no buy links — just regulatory facts and clinical capability summaries.
Editor's Picks
The devices we'd point a colleague to first.
Aidoc
Aidoc Medical
The most-deployed AI radiology platform in 2026 — multi-pathology CT triage with the longest production track record.
CADDIE
Olympus Corporation (Odin Medical Ltd.)
First RCT-grade evidence in colonoscopy AI — the EAGLE 2026 trial.
Caption AI
GE HealthCare (Caption Health)
Bringing point-of-care echocardiography to non-cardiologists. The first FDA-cleared assistive AI for image acquisition.
HeartFlow FFRCT Analysis
HeartFlow, Inc.
Non-invasive coronary FFR. PMA-grade evidence accumulated over a decade of clinical use.
LumineticsCore
Digital Diagnostics (formerly IDx Technologies)
First autonomous AI diagnostic ever cleared in the United States — diabetic retinopathy at the point of care.
Paige Prostate Detect
Paige.AI (acquired by Tempus AI, August 2025)
First FDA-authorized pathology AI — and a study reference for what "computer-aided" means in 2026 practice.
Of 1,304FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1304 devices
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
BIO-RAD LABORATORIES, INC.
Sourced from FDA AI listCardiologyVolta AF-Xplorer
Volta Medical
Sourced from FDA AI listRadiologyClarify DL
GE Medical Systems Israel, Functional Imaging
Sourced from FDA AI listRadiologyClearRead CT CAC
Riverain Technologies, Inc.
Sourced from FDA AI listRadiology1CMR Pro
Mycardium AI Limited
Sourced from FDA AI listRadiologyThe 5000 Compact Series Ultrasound Systems
Philips Ultrasound LLC
Sourced from FDA AI listRadiologyVUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
Vuno Inc.
Sourced from FDA AI listRadiologyicobrain aria
icometrix NV
Sourced from FDA AI listgeneral_plastic_surgeryDermaSensor
DermaSensor Inc.
Sourced from FDA AI listCardiologyInformed Vital Core Application (IVC App)
Mindset Medical, Inc.
Sourced from FDA AI listRadiologynordicMEDiVA
NordicNeurolab AS
Sourced from FDA AI listRadiologySIGNA MAGNUS
GE Medical Systems, LLC
Sourced from FDA AI listRadiologycvi42 Software Application
Circle Cardiovascular Imaging Inc.
Sourced from FDA AI listRadiologyEPIQ Series Diagnostic Ultrasound System
Philips Ultrasound LLC
Sourced from FDA AI listRadiologyHERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listRadiologyEchoSolv AS
Echo IQ Ltd
Sourced from FDA AI listRadiologyVersana Premier; Versana Premier Lotus; LOGIQ F
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listRadiologyMuscleView
Springbok, Inc.
Sourced from FDA AI listRadiologyCAC (gated) Algorithm
BunkerHill Health
Sourced from FDA AI listNeurologyBrainSee
Darmiyan, Inc.
Sourced from FDA AI listRadiologySpineUs System
Verdure Imaging
Sourced from FDA AI listRadiologyMAMMOMAT B.brilliant with Tomosynthesis Option
SIEMENS MEDICAL SOLUTIONS USA, INC.
Sourced from FDA AI listRadiologyCINA-CSpine
Avicenna.AI
Sourced from FDA AI listCardiologyEchoGo Heart Failure (2.0)
Ultromics Limited
Sourced from FDA AI listResults powered by Typesense.