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 1,272FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1272 devices
VBrain
Vysioneer Inc.
Sourced from FDA AI listRadiologyHealthVCF
Zebra Medical Vision Ltd.
Sourced from FDA AI listRadiologyuAI EasyTriage-Rib
Shanghai United Imaging Intelligence Co., Ltd.
Sourced from FDA AI listRadiologyImagio Breast Imaging System
Seno Medical Instruments, Inc.
Sourced from FDA AI listRadiologyRevealAI-Lung
Precision Medical Ventures, Inc. Dba Revealdx
Sourced from FDA AI listRadiologyDeepCT
Deep01 Limited
Sourced from FDA AI listRadiologySwiftMR
Airs Medical, Inc.
Sourced from FDA AI listRadiologyAnnalise Enterprise
Harrison-AI Medical Pty, Ltd.
Sourced from FDA AI listRadiologyEchoNavigator R5.0
Philips Medical Systems Nederland B.V.
Sourced from FDA AI listRadiologyFerriSmart Analysis System
Resonance Health Analysis Services Pty Ltd
Sourced from FDA AI listRadiologyQuantX
Quantitative Insights, Inc
Sourced from FDA AI listCardiologyVivio® LVEDP System
Avicena, LLC
Sourced from FDA AI listRadiologyAI4CMR v2.0
Ai4medimaging Medical Solutions S.A.
Sourced from FDA AI listRadiologyCEPHX3D
Orca Dental AI , Ltd.
Sourced from FDA AI listNeurologyBrainScope TBI
BrainScope Company, Inc.
Sourced from FDA AI listlaboratory_medicineDreaMed Advisor Pro
DreaMed Diabetes, Ltd.
Sourced from FDA AI listRadiologyLunit INSIGHT CXR Triage
Lunit Inc.
Sourced from FDA AI listRadiologyVBrain-OAR
Vysioneer Inc.
Sourced from FDA AI listRadiologyContour ProtégéAI+
Mim Software, Inc.
Sourced from FDA AI listNeurologyencevis (2.1)
AIT Austrian Institute of Technology GmbH
Sourced from FDA AI listRadiologyZiostation2
Ziosoft, Inc.
Sourced from FDA AI listRadiologyJLK-NCCT
JLK, Inc.
Sourced from FDA AI listCardiologyPersonalized Physiology Analytics Engine software
VGBio, Inc (DBA PhysIQ)
Sourced from FDA AI listlaboratory_medicineVITEK MS
BIOMERIEUX, INC.
Sourced from FDA AI listResults powered by Typesense.