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 1,272FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1272 devices
Follicle Clarity
Cycle Clarity
Sourced from FDA AI listCardiologyFEops HEARTguide
FEops NV
Sourced from FDA AI listRadiologyQIR Suite
CASIS Cardiac Simulation & Imaging Software
Sourced from FDA AI listRadiologyStrokeSENS LVO
Circle Neurovascular Imaging, Inc
Sourced from FDA AI listRadiologyHALO
Nico.Lab B.V.
Sourced from FDA AI listRadiologyAccuContour 4.0
Manteia Technologies Co., Ltd.
Sourced from FDA AI listRadiologyBIOGRAPH One
Siemens Healthineers AG
Sourced from FDA AI listgastroenterology_urologyGI Genius System 100 and GI Genius System 200
Cosmo Artificial Intelligence - AI Ltd
Sourced from FDA AI listRadiologyNS-HGlio
Neosoma Inc.
Sourced from FDA AI listCardiologySaranas Early Bird Bleed Monitoring System
Saranas Inc.
Sourced from FDA AI listRadiologyAutomatic Anatomy Recognition (AAR)
Quantitative Radiology Solutions, LLC
Sourced from FDA AI listRadiologyAmCAD-UT
AmCad BioMed Corporation
Sourced from FDA AI listCardiologyGili Pro BioSensor (also known as Gili BioSensor System)
ContinUse Biometrics Ltd.
Sourced from FDA AI listRadiologyDeep Learning Image Reconstruction for Gemstone Spectral Imaging
GE Medical Systems, LLC
Sourced from FDA AI listRadiologyLVivo Software Application
DiA Imaging Analysis Ltd
Sourced from FDA AI listRadiologySIGNA Premier
GE Medical Systems, LLC
Sourced from FDA AI listRadiologyClearRead Xray Pneumothorax
Riverain Technologies, Inc.
Sourced from FDA AI listRadiologyCINA CHEST
Avicenna.AI
Sourced from FDA AI listlaboratory_medicinePhenoMATRIX
Copan Wasp Srl
Sourced from FDA AI listRadiologyCustomize
3D-Side SA
Sourced from FDA AI listCardiologyAtrial Fibrillation History Feature
Apple Inc.
Sourced from FDA AI listRadiologyCaption Interpretation Automated Ejection Fraction Software
Caption Health
Sourced from FDA AI listRadiologyContaCT
Viz.Al, Inc.
Sourced from FDA AI listRadiologyViz RV/LV
Viz.ai, Inc.
Sourced from FDA AI listResults powered by Typesense.