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
qXR-LN
Qure.ai Technologies
Sourced from FDA AI listRadiologyQP-Brain®
Quibim S.L.
Sourced from FDA AI listRadiologyBiograph VK10
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyStrokeViewer Perfusion
NICo-Lab B.V.
Sourced from FDA AI listRadiologyBonelogic
Disior Ltd
Sourced from FDA AI listgastroenterology_urologyNaviCam ProScan
Ankon Technologies co., ltd
Sourced from FDA AI listanesthesiologyTyto Insights for Wheeze Detection
Tyto Care Ltd.
Sourced from FDA AI listRadiologyuOmnispace.MI
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyMAGNETOM Cima.X
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyDTX Studio Clinic (4.0)
Nobel Biocare AB
Sourced from FDA AI listRadiologyLOGIQ Totus
GE Medical Systems Ultrasound and Primary care Diagnostics,
Sourced from FDA AI listRadiologyMyocardial Strain Software Application
Circle Cardiovascular Imaging
Sourced from FDA AI listRadiologyAquilion Serve SP (TSX-307B/1) V1.3
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologySaige-Dx
DeepHealth, Inc.
Sourced from FDA AI listRadiologyVidea Dental Assist
VideaHealth, Inc.
Sourced from FDA AI listRadiologySyngo Carbon Clinicals
Siemens Healthcare GmbH
Sourced from FDA AI listRadiology6440 MyLabX90
Esaote S.p.A.
Sourced from FDA AI listNeurologyClearPoint System (Software Version 2.2)
ClearPoint Neuro Inc.
Sourced from FDA AI listRadiologyMAGNETOM Avanto fit; MAGNETOM Skyra fit
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyBraveCX
Bering Ltd
Sourced from FDA AI listRadiologyMAGNETOM Free.Max; MAGNETOM Free.Star
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyLOGIQ E10
GE Medical Systems Ultrasound and Primary care Diagnostics,
Sourced from FDA AI listRadiologyLOGIQ E10s, LOGIQ Fortis
GE Medical Systems Ultrasound and Primary Care Diagnostic,
Sourced from FDA AI listRadiologyLumify Diagnostic Ultrasound System
Philips Ultrasound
Sourced from FDA AI listResults powered by Typesense.