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
HealthPNX
Zebra Medical Vision Ltd.
Sourced from FDA AI listRadiologyCoLumbo
Smart Soft Healthcare AD
Sourced from FDA AI listRadiologyEFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Ever Fortune. AI Co., Ltd.
Sourced from FDA AI listRadiologyCritical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
GE Medical Systems, LLC
Sourced from FDA AI listRadiologyViewFinder Software Version 1.1
Elaitra Ltd
Sourced from FDA AI listRadiologyRapid RV/LV
iSchema View Inc.
Sourced from FDA AI listRadiologyMVision AI Segmentation
MVision AI
Sourced from FDA AI listCardiologyDEEPVESSEL FFR
KeyaMed NA Inc.
Sourced from FDA AI listOrthopedicsPrecision AI Surgical Planning System (PAI-SPS)
Precision AI Pty, Ltd.
Sourced from FDA AI listRadiologyImagine® Enterprise Suite
Softlink International Private Limited
Sourced from FDA AI listRadiologyBriefCase
Aidoc Medical, Ltd.
Sourced from FDA AI listRadiologyDrAid for Radiology v1
VinBrain Joint Stock Company
Sourced from FDA AI listCardiologyOxehealth Vital Signs
Oxehealth Limited
Sourced from FDA AI listRadiologyAI-Rad Companion Brain MR
Siemens Healthcare GmbH
Sourced from FDA AI listanesthesiologyScanNav Anatomy Peripheral Nerve Block
Intelligent Ultrasound Limited
Sourced from FDA AI listCardiologyCorVista® System
CorVista Health, Inc.
Sourced from FDA AI listgastroenterology_urologyME-APDS; MAGENTIQ-COLO
Magentiq Eye LTD
Sourced from FDA AI listRadiologyIB Lab LAMA
IB Lab GmbH
Sourced from FDA AI listanesthesiologyMasimo SafetyNet
Masimo Corporation
Sourced from FDA AI listRadiologycvi42 Auto Imaging Software Application
Circle Cardiovascular Imaging Inc
Sourced from FDA AI listRadiologyAnnalise Enterprise CXR Triage Pneumothorax
Annalise-AI
Sourced from FDA AI listRadiologyVidea Perio Assist
VideaHealth, Inc.
Sourced from FDA AI listRadiologyClarius AI
Clarius Mobile Health Corp.
Sourced from FDA AI listRadiologyBoneMRI v1.4
MRlguidance B.V.
Sourced from FDA AI listResults powered by Typesense.