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
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listgeneral_plastic_surgeryClaire OCT System
Perimeter Medical Imaging Ai, Inc.
Sourced from FDA AI listRadiologyClarius Ejection Fraction AI
Clarius Mobile Health Corp.
Sourced from FDA AI listRadiologyQT Scanner 2000 Model A
QT Imaging Holdings, Inc.
Sourced from FDA AI listRadiologyViz CTP
Viz.ai, Inc.
Sourced from FDA AI listRadiologyVolpara Imaging Software
Matakina Technology LTD
Sourced from FDA AI listRadiologyVenue
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Sourced from FDA AI listCardiologyPeraServer and PeraTrend
PeraHealth, Inc.
Sourced from FDA AI listRadiologyMagnifico Open (100009900)
Esaote, S.p.A.
Sourced from FDA AI listRadiologyAI Platform 2.2 (AIP002)
Exo Imaging
Sourced from FDA AI listRadiologyAV Cardiac CT
Philips Medical Systems Nederland B.V.
Sourced from FDA AI listRadiologyTeraRecon Cardiovascular.Calcification.CT
Terarecon,Inc.
Sourced from FDA AI listRadiologyaprevo® Digital Segmentation
Carlsmed, Inc.
Sourced from FDA AI listRadiologyDR 800 with MUSICA Dynamic
Agfa HealthCare N.V.
Sourced from FDA AI listRadiologyDM-Density
Densitas, Inc.
Sourced from FDA AI listRadiologyUNiD Spine Analyzer
Medicrea International
Sourced from FDA AI listRadiologyArterys Oncology DL
Arterys Inc.
Sourced from FDA AI listRadiologyIllumeo System
Philips Medical Systems Technologies, Ltd.
Sourced from FDA AI listCardiologyWAVE Clinical Platform
Excel Medical Electronics, LLC
Sourced from FDA AI listCardiologyPreemptiveAI Clinical SDK
Measure Labs, Inc. (Dba Preemptiveai, Inc.)
Sourced from FDA AI listRadiologyBunkerhill Contrast AVC
BunkerHill Health
Sourced from FDA AI listRadiologyQuantib Brain
Quantib BV
Sourced from FDA AI listRadiologyRadiomics App v1.0
Microsoft Corp.
Sourced from FDA AI listRadiologyiQMR
Medic Vision - Imaging Solutions Ltd
Sourced from FDA AI listResults powered by Typesense.