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
FETOLY-HEART
Diagnoly
Sourced from FDA AI listRadiologyLumiNE US; Lumi
Augmedit B.V.
Sourced from FDA AI listRadiologyTRAQinform IQ
AIQ Global, Inc.
Sourced from FDA AI listRadiologyuMI Panorama
Shanghai United Imaging Healthcare Co.,Ltd.
Sourced from FDA AI listRadiologyNeuroQuant
CorTechs Labs, Inc.
Sourced from FDA AI listRadiologyKosmos
EchoNous, Inc.
Sourced from FDA AI listRadiologyHealthCCSng
Nano-X AI Ltd.
Sourced from FDA AI listCardiologyHeartKey® Rhythm
B-Secur Limited
Sourced from FDA AI listRadiologyuMI Panvivo
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listgeneral_plastic_surgeryHYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece
Procept BioRobotics
Sourced from FDA AI listRadiologyAiMIFY (1.x)
Subtle Medical, Inc.
Sourced from FDA AI listRadiologyOmni Legend
GE Medical Systems Israel, Functional Imaging
Sourced from FDA AI listRadiologyAISAP Cardio V1.0
Aisap
Sourced from FDA AI listRadiologyMICSI-RMT
Microstructure Imaging, Inc.
Sourced from FDA AI listRadiologyuMR Omega
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listgastroenterology_urologySKOUT® system
Iterative Scopes, Inc.
Sourced from FDA AI listRadiologyHyper Insight - ICH
SK Inc.
Sourced from FDA AI listRadiologyV8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listRadiologyClarius OB AI
Clarius Mobile Health Corp.
Sourced from FDA AI listRadiologySIS System
Surgical Information Sciences, Inc.
Sourced from FDA AI listRadiologyRUS
Hutom Inc.
Sourced from FDA AI listanesthesiologyTyto Insights for Crackles Detection
Tyto Care Ltd.
Sourced from FDA AI listRadiologyRS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listCardiologyCorvair
AliveCor, Inc.
Sourced from FDA AI listResults powered by Typesense.