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
StrokeViewer Perfusion
NICo-Lab B.V.
Sourced from FDA AI listRadiologySubtleHD-PET (1.x)
Subtle Medical, Inc.
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 listRadiologyLOGIQ E10
GE Medical Systems Ultrasound and Primary care Diagnostics,
Sourced from FDA AI listRadiologySyngo Carbon Clinicals
Siemens Healthcare GmbH
Sourced from FDA AI listRadiologyBrainomix 360 Triage Stroke
Brainomix Limited
Sourced from FDA AI listRadiologyVELMENI for DENTISTS (V4D)
Velmeni Inc.
Sourced from FDA AI listRadiologyVoluson Expert 22, Voluson Expert 20, Voluson Expert 18
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Sourced from FDA AI listRadiologySwiftMR
AIRS Medical Inc.
Sourced from FDA AI listRadiologyMeVis Liver Suite
MeVis Medical Solutions AG
Sourced from FDA AI listRadiologyLumify Diagnostic Ultrasound System
Philips Ultrasound
Sourced from FDA AI listRadiologyUltrasound System 1300
BK Medical Aps
Sourced from FDA AI listRadiologySpotLight/SpotLight Duo (with DLIR option)
Arineta Ltd.
Sourced from FDA AI listRadiologyVeuron-Brain-pAb3
Heuron Co., Ltd.
Sourced from FDA AI listRadiologyNeuViz 128 Multi-Slice CT Scanner System
Neusoft Medical Systems Co., Ltd.
Sourced from FDA AI listCardiologyStethophone Pro
Sparrow Acoustics, Inc.
Sourced from FDA AI listRadiologyDeepTek CXR Analyzer v1.0
DeepTek Medical Imaging Pvt Ltd
Sourced from FDA AI listRadiologyuMI Panorama
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyBriefCase-Triage: CARE Multi-triage CT Body
Aidoc Medical , Ltd.
Sourced from FDA AI listRadiologyLung-CAD
Imagen Technologies, Inc
Sourced from FDA AI listRadiologyOFIX MIS App
Orthofix US LLC
Sourced from FDA AI listRadiologyClarius Ultrasound Scanner
Clarius Mobile Health Corp.
Sourced from FDA AI listResults powered by Typesense.