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
Rapid CTA 360
iSchemaView
Sourced from FDA AI listRadiologyLUMINOS Q.namix T; LUMINOS Q.namix R
Siemens Medical Solutions
Sourced from FDA AI listRadiologyVivid Pioneer
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listRadiologyTAVIPILOT
Caranx Medical
Sourced from FDA AI listRadiologyBunkerhill Abdominal Aortic Quantification (AAQ)
BunkerHill Health
Sourced from FDA AI listRadiologyQLAB Advanced Quantification Software
Philips Healthcare
Sourced from FDA AI listCardiologyTempus ECG-Low EF
Tempus AI, Inc.
Sourced from FDA AI listCardiologyUs2.ca
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Sourced from FDA AI listRadiologyMAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
Siemens Healthcare GmbH
Sourced from FDA AI listCardiologyWithings ECG App
Withings
Sourced from FDA AI listRadiologyAurora
GE Medical Systems Israel
Sourced from FDA AI listRadiologySecond Opinion® CS
Pearl Inc.
Sourced from FDA AI listRadiologysyngo.CT Lung CAD
Siemens Medical Solutions, Inc
Sourced from FDA AI listRadiologyCaption Guidance
Bay Labs, Inc.
Sourced from FDA AI listRadiologyADAS 3D
Galgo Medical S.L
Sourced from FDA AI listlaboratory_medicineDreaMed Advisor Pro
DreaMed Diabetes Ltd
Sourced from FDA AI listRadiologyOncospace
Oncospace, Inc.
Sourced from FDA AI listRadiology6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
Esaote S.p.A.
Sourced from FDA AI listRadiologyBrightHeart View Classifier
BrightHeart
Sourced from FDA AI listCardiologyPhysCade System
PhysCade, Inc.
Sourced from FDA AI listRadiologyIngenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
Philips Medical Systems Nederland B.V.
Sourced from FDA AI listlaboratory_medicineLensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
Bonraybio Co., LTD.
Sourced from FDA AI listRadiologyOpulus Lymphoma Precision
Roche Molecular Systems, Inc.
Sourced from FDA AI listRadiologyHealthICH
Zebra Medical Vision Ltd.
Sourced from FDA AI listResults powered by Typesense.