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
HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
Procept Biorobotics
Sourced from FDA AI listRadiologyTribusConnect
TribusMed Beheer BV
Sourced from FDA AI listRadiologyCritical Care Suite
GE Medical Systems, LLC.
Sourced from FDA AI listRadiologyMethinks CTA Stroke
Methinks Software S.L.
Sourced from FDA AI listRadiologyqCT LN Quant
Qure.ai Technologies
Sourced from FDA AI listRadiologyaprevo® Digital Segmentation
Carlsmed, Inc.
Sourced from FDA AI listgastroenterology_urologyGI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)
Cosmo Artificial Intelligence - AI Ltd
Sourced from FDA AI listRadiologySIS System
Surgical Information Sciences, Inc.
Sourced from FDA AI listCardiologyprolaio eVO2peak Module (Version 1.0)
Prolaio, Inc.
Sourced from FDA AI listRadiologycvi42 Software Application
Circle Cardiovascular Imaging Inc.
Sourced from FDA AI listRadiologyCritical Care Suite with Endotracheal Tube Positing AI algorithm
GE Medical Systems, LLC
Sourced from FDA AI listCardiologyGili Pro BioSensor (also known as Gili BioSensor System)
ContinUse Biometrics Ltd.
Sourced from FDA AI listRadiologyClarius Ejection Fraction AI
Clarius Mobile Health Corp.
Sourced from FDA AI listRadiologyHeuron ICH
Heuron Co., Ltd.
Sourced from FDA AI listRadiologyInferRead Lung CT.AI
Infervision Medical Technology Co., Ltd.
Sourced from FDA AI listNeurologyDreem 3S
Beacon Biosignals, Inc.
Sourced from FDA AI listRadiologyMediAI-BA
Crescom Co., Ltd.
Sourced from FDA AI listRadiologyCAC (gated) Algorithm
BunkerHill Health
Sourced from FDA AI listRadiologyElucidVivo A.3
Elucid Bioimaging Inc.
Sourced from FDA AI listRadiologyVantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyHYPER DLR
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyART-Plan (v.2.2.0)
Therapanacea SAS
Sourced from FDA AI listRadiologyBU-CAD
TaiHao Medical Inc.
Sourced from FDA AI listRadiologyAplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
Canon Medical Systems Corporation
Sourced from FDA AI listResults powered by Typesense.