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 1,358FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1358 devices
Avive Automated External Defibrillator (AED) System
Avive Solutions, Inc.
Sourced from FDA AI listRadiologyVBrain-OAR
Vysioneer Inc.
Sourced from FDA AI listRadiologySwiftMR
Airs Medical, Inc.
Sourced from FDA AI listRadiologyEchoNavigator R5.0
Philips Medical Systems Nederland B.V.
Sourced from FDA AI listNeurologyBrainScope TBI
BrainScope Company, Inc.
Sourced from FDA AI listlaboratory_medicineDreaMed Advisor Pro
DreaMed Diabetes, Ltd.
Sourced from FDA AI listCardiologyLINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
Medtronic, Inc.
Sourced from FDA AI listRadiologyAI4CMR v2.0
Ai4medimaging Medical Solutions S.A.
Sourced from FDA AI listRadiologyMEDO-Thyroid
MEDO DX Pte. Ltd.
Sourced from FDA AI listRadiologyRadiation Planning Assistant (RPA)
University of Texas, MD Anderson Cancer Center
Sourced from FDA AI listNeurologyNeuroRPM
New Touch Digital Inc.
Sourced from FDA AI listRadiologyAdvanced Algorithms for Treatment Management Applications (AATMA)
Elekta Solutions AB
Sourced from FDA AI listNeurologyencevis (2.1)
AIT Austrian Institute of Technology GmbH
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 listRadiologyProFound AI Software V3.0
iCAD Inc.
Sourced from FDA AI listRadiologyAxial3D Insight
Axial Medical Printing Limited
Sourced from FDA AI listRadiologyMEDO ARIA
Medo.ai
Sourced from FDA AI listRadiologyAccuContour
Xiamen Manteia Technology LTD.
Sourced from FDA AI listRadiologyVelacur
Sonic Incytes
Sourced from FDA AI listCardiologyRX-1 Rhythm Express Remote Cardiac Monitoring System
VivaQuant Inc.
Sourced from FDA AI listRadiologyAI-Rad Companion Prostate MR
Siemens Medical Solutions USA Inc.
Sourced from FDA AI listCardiologyFFRct
HeartFlow, Inc
Sourced from FDA AI listRadiologyOsteoDetect
Imagen Technologies, Inc.
Sourced from FDA AI listResults powered by Typesense.