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
PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
PATHWORK DIAGNOSTICS, INC.
Sourced from FDA AI listlaboratory_medicineLensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
Bonraybio Co., Ltd.
Sourced from FDA AI listgeneral_plastic_surgeryDUNE MEDICAL DEVICES MARGINPROBE SYSTEM
Dilon Medical Technologies, Ltd.
Sourced from FDA AI listRadiologyAplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyArterys MICA
Arterys Inc.
Sourced from FDA AI listdentalTRIOS Dx (R1)
3Shape TRIOS A/S
Sourced from FDA AI listRadiologyECHELON Synergy MRI System
FUJIFILM Healthcare Corporation
Sourced from FDA AI listanesthesiologyHuxley SANSA Home Sleep Apnea Test (1000-00)
Huxley Medical
Sourced from FDA AI listCardiologyCobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I
Medtronic Cardiac Rhythm Disease Management
Sourced from FDA AI listRadiologyRelu Creator
Relu BV
Sourced from FDA AI listRadiologyHealthPPT
Zebra Medical Vision Ltd.
Sourced from FDA AI listgastroenterology_urologyEndoScreener
Chengdu Wision Medical Device Co., LTD.
Sourced from FDA AI listCardiologyFEops HEARTguide Simulation Application
Feops NV
Sourced from FDA AI listRadiologyLimbus Contour
Limbus AI Inc.
Sourced from FDA AI listCardiologyAurora EV ICD (DVEA3E4)
Medtronic, Inc.
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 listRadiologyAIR Recon DL
Ge Medical Systems, LLC
Sourced from FDA AI listRadiologyLumify Diagnostic Ultrasound System
Philips Ultrasound, LLC
Sourced from FDA AI listRadiologyBioticsAI
Bioticsai, Inc.
Sourced from FDA AI listCardiologyeMurmur Heart AI
Csd Labs
Sourced from FDA AI listRadiologyPVAD IQ Software
Ultrasight , Ltd.
Sourced from FDA AI listRadiologyART-Plan+ (v3.1.0)
Therapanacea Sas
Sourced from FDA AI listResults powered by Typesense.