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
AISAP Cardio V1.0
Aisap
Sourced from FDA AI listlaboratory_medicineSeaman Pro/Seaman
Checkcells, Inc.
Sourced from FDA AI listRadiologyMICSI-RMT
Microstructure Imaging, Inc.
Sourced from FDA AI listRadiologyDEEPVESSEL Plaque
Keya Medical Technology Co., Ltd.
Sourced from FDA AI listgastroenterology_urologyMAGENTIQ-COLO (ME-APDS)
Magentiq Eye, Ltd.
Sourced from FDA AI listRadiologyChange Healthcare Anatomical AI
Change Healthcare Canada Company
Sourced from FDA AI listanesthesiologyTyto Insights for Crackles Detection
Tyto Care Ltd.
Sourced from FDA AI listRadiologyOverjet Iris Intelligent Imaging System
Overjet, Inc.
Sourced from FDA AI listRadiologyRUS
Hutom Inc.
Sourced from FDA AI listRadiologyuMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyADAS 3D
Adas3D Medical S.L.
Sourced from FDA AI listRadiologyRS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listCardiologyImpala
AliveCor, Inc.
Sourced from FDA AI listRadiologySyngo Carbon Enterprise Access (VA40A)
Siemens Healthcare GmbH
Sourced from FDA AI listdentalDentalMonitoring
Dental Monitoring SAS
Sourced from FDA AI listCardiologyCorvair
AliveCor, Inc.
Sourced from FDA AI listdentalRAYDENT SW
RAY Co., Ltd.
Sourced from FDA AI listRadiologyEthos Treatment Management (3.0); Ethos Treatment Planning (2.0)
Varian Medical Systems Inc.
Sourced from FDA AI listRadiologyCardIQ Suite
GE Medical Systems SCS
Sourced from FDA AI listCardiologyASSURE Wearable ECG
Kestra Medical Technologies, Inc.
Sourced from FDA AI listRadiologyECHELON Synergy V10.0
Fujifilm Healthcare Americas Corporation
Sourced from FDA AI listRadiologyFolliscan
Mim Fertility
Sourced from FDA AI listRadiologyDS Core CBCT Anatomy
Dentsply Sirona
Sourced from FDA AI listRadiologyuMR Jupiter
Shanghai United Imaging Healthcare Co., Ltd
Sourced from FDA AI listResults powered by Typesense.