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
HealthOST
NanoxAI Ltd.
Sourced from FDA AI listRadiologyRayStation 11B
RaySearch Laboratories AB (publ)
Sourced from FDA AI listRadiologyVidea Caries Assist
VideaHealth, Inc
Sourced from FDA AI listRadiologyINT Contour
Carina Medical LLC
Sourced from FDA AI listRadiologyClariPulmo
ClariPi Inc.
Sourced from FDA AI listRadiologyHERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
Samsung Medison Co., LTD
Sourced from FDA AI listRadiologyMAGNETOM Avanto Fit
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listCardiologyZEUS Platform (FG0501US)
iRhythm Technologies, Inc.
Sourced from FDA AI listlaboratory_medicineAthelas Home
Athelas Inc.
Sourced from FDA AI listCardiologyAliveCor QT Service
AliveCor, Inc.
Sourced from FDA AI listRadiologyVoluson P6, Voluson P8
GE Healthcare
Sourced from FDA AI listRadiologyRevolution Ascend
GE Healthcare Japan Corporation
Sourced from FDA AI listRadiologyMicro C Medical Imaging System, M01
OXOS Medical, Inc.
Sourced from FDA AI listRadiologySIGNA Hero
GE Healthcare (GE Medical Systems, LLC)
Sourced from FDA AI listRadiologySIGNA Prime
GE Healthcare (Tianjin) Company Limited
Sourced from FDA AI listRadiologyQuantib ND
Quantib B.V.
Sourced from FDA AI listRadiologyEclipse II with Smart Noise Cancellation
Carestream Health, Inc.
Sourced from FDA AI listRadiologyCritical Care Suite with Enteric Tube Positioning AI Algorithm
Ge Medical Systems, LLC
Sourced from FDA AI listRadiologyMAGNETOM Vida with syngo MR XA50A
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyDeep Learning Image Reconstruction
GE Medical Systems, LLC.
Sourced from FDA AI listRadiologyqXR-Detect
Qure.Ai Technologies
Sourced from FDA AI listRadiologyLungMaps
Siemens Healthineers AG
Sourced from FDA AI listanesthesiologyRX-1 Sleep
Vivaquant, Inc. Dba Rhythm Express
Sourced from FDA AI listRadiologyCydar EV (Series B) and Cydar EV Maps
Cydar Ltd.
Sourced from FDA AI listResults powered by Typesense.