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
Global Hypoperfusion Index (GHI) Algorithm
Edwards Lifesciences, LLC
Sourced from FDA AI listRadiologyViz SDH
Viz.ai, Inc.
Sourced from FDA AI listRadiologyTechCare Trauma
Milvue
Sourced from FDA AI listRadiologyViz ANEURYSM, Viz ANX
Viz.ai, Inc.
Sourced from FDA AI listRadiologyClariSIGMAM
ClariPi Inc.
Sourced from FDA AI listRadiologyAI-Rad Companion Organs RT
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listNeurologyCOMPLETE CONTROL System Gen2
Coapt, LLC
Sourced from FDA AI listgastroenterology_urologyGI Genius
Cosmo Artificial Intelligence - AI Ltd
Sourced from FDA AI listanesthesiologySnoreSounds
APPIAN MEDICAL, INC.
Sourced from FDA AI listRadiologyContour ProtegeAI
MIM Software Inc.
Sourced from FDA AI listRadiologyvascuCAP
Elucid Bioimaging Inc.
Sourced from FDA AI listCardiologyAcumen Hypotension Prediction Index (HPI) Feature Software
Edwards Lifesciences LLC
Sourced from FDA AI listRadiologySurgicalAR
MEDIVIS, Inc.
Sourced from FDA AI listRadiologyContaCT
Viz.Al, Inc.
Sourced from FDA AI listCardiologyRooti Rx ECG Event Recorder, Rooti Link APP Software
Rooti Labs Ltd.
Sourced from FDA AI listRadiologyAutomatic Anatomy Recognition (AAR)
Quantitative Radiology Solutions, LLC
Sourced from FDA AI listRadiologyLunit INSIGHT DBT v1.1
Lunit Inc.
Sourced from FDA AI listCardiologySamsung ECG Monitor Application with Irregular Heart Rhythm Notification
Samsung Electronics Co., Ltd
Sourced from FDA AI listRadiologyCeevra Reveal 3
Ceevra, Inc.
Sourced from FDA AI listRadiologyBoneView
Gleamer
Sourced from FDA AI listRadiologyEchoPAC Software Only / EchoPAC Plug-in
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listanesthesiologyPMD-200
Medasense Biometrics Ltd.
Sourced from FDA AI listRadiologyVinDr-Mammo
VinBigData Joint Stock Company
Sourced from FDA AI listRadiologyQuantX
Quantitative Insights, Inc
Sourced from FDA AI listResults powered by Typesense.