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
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listRadiologyHipCheck
Stryker Corp.
Sourced from FDA AI listCardiologyLow Ejection Fraction AI-ECG Algorithm
Anumana, Inc.
Sourced from FDA AI listRadiologyMomentum Spine
Momentum Health Inc.
Sourced from FDA AI listRadiologyLOGIQ Fortis
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listRadiologyNEUROShield
In-Med Prognostics L3C
Sourced from FDA AI listRadiologyXIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologySubtleHD-CT (1.x)
Subtle Medical, Inc.
Sourced from FDA AI listlaboratory_medicineMinuteful-kidney test
Healthy.io Ltd.
Sourced from FDA AI listRadiologyuMR 680
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyOverjet Periapical Radiolucency Assist
Overjet, Inc
Sourced from FDA AI listlaboratory_medicineAI100 with Shonit
SigTuple Technologies Pvt. Ltd.
Sourced from FDA AI listRadiologyAquilion Serve (TSX-307A/1) V1.3
Canon Medical Systems Corporation
Sourced from FDA AI listCardiologyWithings Scan Monitor 2.0
Withings
Sourced from FDA AI listRadiologyVisiRad XR
Imidex Inc.
Sourced from FDA AI listRadiologyAIRAscore
AIRAmed GmbH
Sourced from FDA AI listRadiologyVERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
Spectrum Dynamics Medical, Ltd.
Sourced from FDA AI listCardiologyPerin Health System (PHD80060-2)
Perin Health Devices, LLC
Sourced from FDA AI listRadiologyJazz
AI Medical AG
Sourced from FDA AI listRadiologyDiagnocat
DGNCT, LLC
Sourced from FDA AI listRadiologyMOZI TPS
Manteia Technologies Co., Ltd.
Sourced from FDA AI listRadiologysyngo.CT Lung CAD (Version VD30)
Siemens Healthcare GmbH
Sourced from FDA AI listRadiologyBiograph Vision.X and Biograph Vision.X Edge
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listCardiologyBodyGuardian Remote Monitoring System (BGRMS v3.0)
Boston Scientific Cardiac Diagnostic Technologies, Inc.
Sourced from FDA AI listResults powered by Typesense.