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
HALO
Nico.Lab B.V.
Sourced from FDA AI listgastroenterology_urologyGI Genius
Cosmo Artificial Intelligence - AI, LTD
Sourced from FDA AI listRadiologyCorInsights MRI
ADM Diagnostics, Inc.
Sourced from FDA AI listlaboratory_medicineLensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
Bonraybio Co., Ltd.
Sourced from FDA AI listRadiologyNeurophet AQUA AD Plus
Neurophet., Inc.
Sourced from FDA AI listRadiologyLVivo Software Application
DiA Imaging Analysis Ltd
Sourced from FDA AI listNeurologyStealth AXiS Surgical System with Stealth AXiS Spine clinical application
Medtronic Navigation, Inc.
Sourced from FDA AI listRadiologyMI View&GO
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyVBrain
Vysioneer Inc.
Sourced from FDA AI listRadiologyClariSIGMAM
ClariPi Inc.
Sourced from FDA AI listRadiologyqER-Quant
Qure.ai Technologies
Sourced from FDA AI listNeurologyCognoa ASD Diagnosis Aid
Cognoa, Inc.
Sourced from FDA AI listRadiologyAI-Rad Companion Organs RT
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyuWS-MR
Shanghai United Imaging Healthcare Co., Ltd
Sourced from FDA AI listRadiologyRapid Aortic Measurements
iSchemaView, Inc.
Sourced from FDA AI listNeurologyEyeBOX
Oculogica, Inc.
Sourced from FDA AI listRadiologyEzra Plexo Software
Ezra AI Inc.
Sourced from FDA AI listRadiologyHealthCXR
Zebra Medical Vision, Ltd.
Sourced from FDA AI listRadiologycmTriage
CureMetrix, Inc
Sourced from FDA AI listRadiologyContaCT
Viz.Al, Inc.
Sourced from FDA AI listNeurologyAhead 300
BRAINSCOPE COMPANY INC
Sourced from FDA AI listRadiologyLigence Heart
Ligence Uab
Sourced from FDA AI listCardiologyViz HCM
Viz.ai, Inc.
Sourced from FDA AI listRadiologyWRDensity by Whiterabbit.ai
Whiterabbit.ai Inc.
Sourced from FDA AI listResults powered by Typesense.