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
EnsoSleep
EnsoData, Inc.
Sourced from FDA AI listRadiologyClever One
Ewoosoft Co., Ltd
Sourced from FDA AI listRadiologyMethinks CTA Stroke
Methinks Software S.L.
Sourced from FDA AI listCardiologyprolaio eVO2peak Module (Version 1.0)
Prolaio, Inc.
Sourced from FDA AI listRadiologyBriefCase, RIB Fractures Triage (RibFx)
Aidoc Medical, Ltd.
Sourced from FDA AI listNeurologyDreem 3S
Beacon Biosignals, Inc.
Sourced from FDA AI listRadiologyMediAI-BA
Crescom Co., Ltd.
Sourced from FDA AI listRadiologyAnnalise Enterprise CTB Triage Trauma
Annalise-AI Pty Ltd
Sourced from FDA AI listRadiologyNvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
NinePoint Medical, Inc.
Sourced from FDA AI listRadiologyIRISeg
Intuitive Surgical, Inc.
Sourced from FDA AI listRadiologya2z-Unified-Triage
A2z Radiology Ai, Inc.
Sourced from FDA AI listObstetrics / GynecologyKIDScore D3
Vitrolife A/S
Sourced from FDA AI listRadiologyPeekMed web
Peek Health, S.A.
Sourced from FDA AI listRadiologyAlzevita
TOPIA MEDTECH LIMITED
Sourced from FDA AI listRadiologySyngo Carbon Clinicals (VA41)
Siemens Healthineers AG
Sourced from FDA AI listgeneral_plastic_surgeryHYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
Procept Biorobotics
Sourced from FDA AI listRadiologyAVIEW CAC
Coreline Soft Co., Ltd.
Sourced from FDA AI listRadiologyAI-CVD
HeartLung Corporation
Sourced from FDA AI listNeurologyDeepRESP
Nox Medical Ehf
Sourced from FDA AI listRadiologyLigence Heart
Ligence, UAB
Sourced from FDA AI listRadiologyGBrain MRI
Galileo CDS, Inc
Sourced from FDA AI listRadiologyUNiD Spine Analyzer
Medicrea International S.A.S. (Medtronic)
Sourced from FDA AI listRadiologyCT Cardiomegaly
Innolitics, LLC
Sourced from FDA AI listRadiologyBrain WMH
Quantib BV
Sourced from FDA AI listResults powered by Typesense.