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
MR 5300 and MR 7700 R11 MR Systems
Philips Medical Systems Nederlands B.V.
Sourced from FDA AI listRadiologyV8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listCardiologyVX1+
Volta Medical
Sourced from FDA AI listRadiologySIGNA Victor
GE Healthcare (Tianjin) Company Limited
Sourced from FDA AI listCardiologySTAR Apollo Mapping System
Rhythm Al, Ltd
Sourced from FDA AI listRadiologyOverjet Calculus Assist
Overjet Inc.
Sourced from FDA AI listRadiologyuMR Omega with uWS-MR-MRS
Shanghai United Imaging Healthcare Co.,Ltd.
Sourced from FDA AI listRadiologyNeurophet SCALE PET
Neurophet., Inc.
Sourced from FDA AI listRadiologyuMR Astra
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologySynapse Lung Nodule AI
Fujifilm Corporation
Sourced from FDA AI listRadiologyDS Core Detect
Dentsply Sirona, Inc.
Sourced from FDA AI listanesthesiologyVISIONAIR
PacificMD Biotech Llc
Sourced from FDA AI listRadiologyLOGIQ Totus
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listCardiologyCorvair Monza
AliveCor, Inc.
Sourced from FDA AI listRadiologyLiverMultiScan v5 (LMSv5)
Perspectum
Sourced from FDA AI listRadiologyAorta-CAD
Imagen Technologies, Inc
Sourced from FDA AI listRadiologyAI Platform (AIP001)
Exo Inc
Sourced from FDA AI listRadiologyMAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologysyngo.via RT Image Suite
Siemens Medical Solutions USA Inc.
Sourced from FDA AI listRadiologyTeraRecon Neuro
TeraRecon, Inc
Sourced from FDA AI listNeurologyMeRT System
Wave Neuroscience
Sourced from FDA AI listRadiologyWatchMate Software
Anumana, Inc.
Sourced from FDA AI listRadiologyACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyABMD Software
HeartLung Corporation
Sourced from FDA AI listResults powered by Typesense.