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
ScanNav Anatomy Peripheral Nerve Block
Intelligent Ultrasound Limited
Sourced from FDA AI listCardiologyCorVista® System
CorVista Health, Inc.
Sourced from FDA AI listanesthesiologyMasimo SafetyNet
Masimo Corporation
Sourced from FDA AI listgastroenterology_urologyME-APDS; MAGENTIQ-COLO
Magentiq Eye LTD
Sourced from FDA AI listRadiologyIB Lab LAMA
IB Lab GmbH
Sourced from FDA AI listRadiologyVidea Perio Assist
VideaHealth, Inc.
Sourced from FDA AI listRadiologyClarius AI
Clarius Mobile Health Corp.
Sourced from FDA AI listRadiologyBoneMRI v1.4
MRlguidance B.V.
Sourced from FDA AI listNeurologySomnoMetry
Neumetry Medical Inc
Sourced from FDA AI listRadiologyCINA CHEST
Avicenna.AI
Sourced from FDA AI listRadiologyQIR Suite
CASIS Cardiac Simulation & Imaging Software
Sourced from FDA AI listRadiologyFollicle Clarity
Cycle Clarity
Sourced from FDA AI listRadiologyAvenda Health AI Prostate Cancer Planning Software
Avenda Health, Inc.
Sourced from FDA AI listNeurologyCognoa ASD Diagnosis Aid
Cognoa, Inc.
Sourced from FDA AI listRadiologyBIOGRAPH One
Siemens Healthineers AG
Sourced from FDA AI listRadiologyAccuContour 4.0
Manteia Technologies Co., Ltd.
Sourced from FDA AI listCardiologySaranas Early Bird Bleed Monitoring System
Saranas Inc.
Sourced from FDA AI listRadiologyuWS-MR
Shanghai United Imaging Healthcare Co., Ltd
Sourced from FDA AI listgastroenterology_urologyGI Genius System 100 and GI Genius System 200
Cosmo Artificial Intelligence - AI Ltd
Sourced from FDA AI listRadiologyAmCAD-UT
AmCad BioMed Corporation
Sourced from FDA AI listRadiologyDeep Learning Image Reconstruction for Gemstone Spectral Imaging
GE Medical Systems, LLC
Sourced from FDA AI listRadiologyHealthICH
Zebra Medical Vision Ltd.
Sourced from FDA AI listRadiologySIGNA Premier
GE Medical Systems, LLC
Sourced from FDA AI listRadiologyCaption Interpretation Automated Ejection Fraction Software
Caption Health
Sourced from FDA AI listResults powered by Typesense.