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
LVivo Software Application
DiA Imaging Analysis Ltd.
Sourced from FDA AI listRadiologyNeuroICH
Neurocareai Inc.
Sourced from FDA AI listRadiologySMART Bun-Yo-Matic CT
Disior Ltd
Sourced from FDA AI listRadiologyCardiac CT Function Software Application
Circle Cardiovascular Imaging
Sourced from FDA AI listRadiologyPreview Shoulder
Genesis Software Innovations
Sourced from FDA AI listRadiologyNeurophet AQUA (V3.1)
Neurophet, Inc.
Sourced from FDA AI listRadiologyLunit INSIGHT DBT v1.1
Lunit Inc.
Sourced from FDA AI listRadiologyRayvolve
AZmed SAS
Sourced from FDA AI listRadiologyVinDr-Mammo
VinBigData Joint Stock Company
Sourced from FDA AI listRadiologyVisAble.IO
Techsomed
Sourced from FDA AI listRadiologyCINA-iPE
Avicenna.AI
Sourced from FDA AI listRadiologyinHEART Models
inHEART, SAS
Sourced from FDA AI listNeurologyREMI AI Discrete Detection Module
Epitel, Inc.
Sourced from FDA AI listRadiologySonix Health
Ontact Health Co., Ltd
Sourced from FDA AI listCardiologyEchoGo Amyloidosis (1.0)
Ultromics Limited
Sourced from FDA AI listRadiologyuAI Easy Triage ICH
Shanghai United Imaging Intelligence Co., Ltd.
Sourced from FDA AI listCardiologyAcumen Assisted Fluid Management (AFM) Software Feature
Edwards Lifesciences, LLC
Sourced from FDA AI listRadiologyMedihub Prostate
JLK Inc.
Sourced from FDA AI listRadiologyuPMR 790
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyViz HDS, Viz Volume Plus, Viz ICH+
Viz.ai, Inc.
Sourced from FDA AI listRadiologyFibresolve
Imvaria, Inc
Sourced from FDA AI listNeurologyNeuroMatch
LVIS Corporation
Sourced from FDA AI listRadiologyContour+ (MVision AI Segmentation)
MVision AI Oy
Sourced from FDA AI listRadiologyCoLumbo
Smart Soft Healthcare
Sourced from FDA AI listResults powered by Typesense.