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
CINA-CSpine
Avicenna.AI
Sourced from FDA AI listRadiologyFibresolve
Imvaria, Inc
Sourced from FDA AI listRadiologyqXR-LN
Qure.ai Technologies
Sourced from FDA AI listRadiologyAchieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
Philips Medical Systems Nederland B.V.
Sourced from FDA AI listRadiologyLOGIQ E10s, LOGIQ Fortis
GE Medical Systems Ultrasound and Primary Care Diagnostic,
Sourced from FDA AI listRadiologyEFAI RTSuite CT HN-Segmentation System
Ever Fortune.AI Co., Ltd.
Sourced from FDA AI listRadiologyRT-Mind-AI
MedMind Technology Co., Ltd.
Sourced from FDA AI listRadiologyEchoGo Core (2.0)
Ultromics Limited
Sourced from FDA AI listNeurologyEnsoSleep
EnsoData, Inc.
Sourced from FDA AI listRadiologyHALO
Nico.Lab B.V.
Sourced from FDA AI listRadiologySynapse 3D Base Tools (V7.0)
FUJIFILM Corporation
Sourced from FDA AI listRadiologysyngo Dynamics (Version VA41D)
Siemens Healthcare GmbH
Sourced from FDA AI listRadiologyuPMR 790
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyEFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Ever Fortune. AI Co., Ltd.
Sourced from FDA AI listRadiologyqER-Quant
Qure.ai Technologies
Sourced from FDA AI listRadiologySpine CAMP (1.1)
Medical Metrics, Inc.
Sourced from FDA AI listRadiologyAutoContour Model RADAC V3
Radformation, Inc.
Sourced from FDA AI listRadiologyEzra Flash
Ezra AI, Inc.
Sourced from FDA AI listRadiologyCoLumboX
Smart Soft Healthcare AD
Sourced from FDA AI listRadiologyEFAI ChestSuite XR Pleural Effusion Assessment System
Ever Fortune.AI Co., Ltd.
Sourced from FDA AI listRadiologyiQ-solutions
Sydney Neuroimaging Analysis Centre Pty Ltd
Sourced from FDA AI listRadiologyLVivo Software Application
DiA Imaging Analysis Ltd
Sourced from FDA AI listRadiologyBrainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
Brainlab AG
Sourced from FDA AI listCardiologyCLEWICU System
Clew Medical Ltd.
Sourced from FDA AI listResults powered by Typesense.