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 1,272FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1272 devices
Relu Creator
Relu BV
Sourced from FDA AI listRadiologyBU-CAD
TaiHao Medical Inc.
Sourced from FDA AI listRadiologyLimbus Contour
Limbus AI Inc.
Sourced from FDA AI listgastroenterology_urologyEndoScreener
Chengdu Wision Medical Device Co., LTD.
Sourced from FDA AI listRadiologyTEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co.,LTD
Sourced from FDA AI listRadiologyHERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listRadiologyVantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyBrainomix 360 e-ASPECTS
Brainomix Limited
Sourced from FDA AI listRadiologyART-Plan+ (v3.1.0)
Therapanacea Sas
Sourced from FDA AI listRadiologyPVAD IQ Software
Ultrasight , Ltd.
Sourced from FDA AI listCardiologyAssert-IQ (DM5100)
Abbott Medical
Sourced from FDA AI listRadiologyAIR Recon DL
Ge Medical Systems, LLC
Sourced from FDA AI listRadiologyLumify Diagnostic Ultrasound System
Philips Ultrasound, LLC
Sourced from FDA AI listRadiologyNeosoma Brain Mets
Neosoma, Inc.
Sourced from FDA AI listRadiologyBioticsAI
Bioticsai, Inc.
Sourced from FDA AI listCardiologyIRNF App
Apple Inc.
Sourced from FDA AI listCardiologyeMurmur Heart AI
Csd Labs
Sourced from FDA AI listanesthesiologySANSA HSAT
Huxley Medical
Sourced from FDA AI listRadiologyFetal EchoScan (v1.2)
Brightheart
Sourced from FDA AI listgastroenterology_urologyGastric Alimetry
Alimetry , Ltd.
Sourced from FDA AI listRadiologyCartesion Prime (PCD-1000A/3) V10.21
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyOEC One CFD
Ge Hualun Medical Systems Co. , Ltd.
Sourced from FDA AI listRadiologyPrecise Position
Philips Healthcare (Suzhou) Co., Ltd.
Sourced from FDA AI listRadiology7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
Esaote, S.P.A.
Sourced from FDA AI listResults powered by Typesense.