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
Cirrus Resting State fMRI Software
Sora Neuroscience, Inc.
Sourced from FDA AI listRadiologyLARALAB
LARALAB GmbH
Sourced from FDA AI listRadiologyAnnalise Enterprise CTB Triage Trauma
Annalise-AI Pty Ltd.
Sourced from FDA AI listCardiologyECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
Anumana, Inc.
Sourced from FDA AI listRadiologySynapse PACS (7.5)
FUJIFILM Healthcare Americas Corporation
Sourced from FDA AI listNeurologyTMINI Miniature Robotic System
THINK Surgical, Inc.
Sourced from FDA AI listRadiologyIRISeg
Intuitive Surgical Inc.
Sourced from FDA AI listRadiologyTumorSight Viz
SimBioSys, Inc.
Sourced from FDA AI listRadiologyLungVision
BodyVision Medical Ltd.
Sourced from FDA AI listCardiologyCorVista System with PH Add-On
Analytics for Life, Inc.
Sourced from FDA AI listRadiologyMAGNETOM Viato.Mobile
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologycmAngio® (V1.6)
CureMetrix, Inc.
Sourced from FDA AI listRadiologyContour ProtégéAI+
MIM Software Inc.
Sourced from FDA AI listRadiologyPreview Shoulder
Genesis Software Innovations
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 listRadiologyAudaxCeph Cephalogram Analysis Software
Audax d.o.o.
Sourced from FDA AI listNeurologyautoSCORE (V 2.0.0)
Holberg EEG AS
Sourced from FDA AI listRadiologyLVivo Software Application
DiA Imaging Analysis Ltd.
Sourced from FDA AI listRadiologyRayvolve
AZmed SAS
Sourced from FDA AI listRadiologyVisAble.IO
Techsomed
Sourced from FDA AI listRadiologyinHEART Models
inHEART, SAS
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 listResults powered by Typesense.