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
NEUROShield
In-Med Prognostics L3C
Sourced from FDA AI listRadiologyXIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
Canon Medical Systems Corporation
Sourced from FDA AI listgastroenterology_urologyCADDIE
Odin Medical Limited
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 listRadiologyMAGNETOM Viato.Mobile
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyTranspara Density 1.0.0
Screenpoint Medical B.V.
Sourced from FDA AI listRadiologyJazz
AI Medical AG
Sourced from FDA AI listCardiologyWithings Scan Monitor 2.0
Withings
Sourced from FDA AI listRadiologyVisiRad XR
Imidex Inc.
Sourced from FDA AI listNeurologySpine Planning (2.0), Elements Spine Planning, Elements Planning Spine
Brainlab AG
Sourced from FDA AI listRadiologyRapid Aneurysm Triage and Notification
iSchemaView Inc.
Sourced from FDA AI listRadiologyAIRAscore
AIRAmed GmbH
Sourced from FDA AI listRadiologyBiograph Vision.X and Biograph Vision.X Edge
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listCardiologyAusculThing ACC
AusculThing Oy
Sourced from FDA AI listNeurologyCranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
Brainlab AG
Sourced from FDA AI listRadiologyMOZI TPS
Manteia Technologies Co., Ltd.
Sourced from FDA AI listRadiologyuOmnispace
Shanghai United Imaging Healthcare Co., Ltd
Sourced from FDA AI listRadiologysyngo.CT Lung CAD (Version VD30)
Siemens Healthcare GmbH
Sourced from FDA AI listRadiologySpine CAMP (1.1)
Medical Metrics, Inc.
Sourced from FDA AI listNeurologyEarliPoint
EarliTec Diagnostics, Inc
Sourced from FDA AI listRadiologyVoluson SWIFT; Voluson SWIFT+
GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC
Sourced from FDA AI listRadiologyEz3D-i /E3
Ewoosoft Co., Ltd
Sourced from FDA AI listRadiologySpine Auto Views
GE Medical Systems SCS
Sourced from FDA AI listResults powered by Typesense.