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
MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise
Siemens Healthcare GmbH
Sourced from FDA AI listPathologyGalen Second Read
Ibex Medical Analytics Ltd.
Sourced from FDA AI listRadiologyOptimMRI (v2)
Rebrain, SAS
Sourced from FDA AI listRadiologyDeepCatch
MEDICALIP Co., Ltd
Sourced from FDA AI listRadiologyCydar EV
Cydar Ltd.
Sourced from FDA AI listRadiologyAlphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyData Analysis Facilitation Suite (DAFS)
Voronoi Health Analytics Incorporated
Sourced from FDA AI listRadiologysyngo.via RT Image Suite VC10
Varian Medical Systems, Inc.
Sourced from FDA AI listRadiologyAquilion ServeSP (TSX-307B) V2.0
Canon Medical Systems Corporation
Sourced from FDA AI listRadiology3mensio Workstation
Pie Medical Imaging BV
Sourced from FDA AI listRadiologyInferCare RECIST
Beijing Infervision Healthcare Medical Technology Co., Ltd.
Sourced from FDA AI listRadiologyOverjet Image Enhancement Assist
Overjet Inc
Sourced from FDA AI listlaboratory_medicineDario Blood Glucose Monitoring System
LabStyle Innovations Ltd.
Sourced from FDA AI listRadiologySonio Detect (v3)
Sonio
Sourced from FDA AI listRadiologySOMATOM X.cite; SOMATOM X.ceed
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyCT Rembra RT; CT Areta RT; CT Rembra
Philips Healthcare (Suzhou) Co., Ltd.
Sourced from FDA AI listRadiologyTrinias
Shimadzu Corporation
Sourced from FDA AI listRadiologyUltrasound Workspace (UWS 6.0)
Philips Ultrasound LLC
Sourced from FDA AI listCardiologyLINQ II Insertable Cardiac Monitor
Medtronic, Inc.
Sourced from FDA AI listNeurologyENT EM
Brainlab AG
Sourced from FDA AI listRadiologyIRIS INTELLIGENT RETINAL IMAGING SYSTEM
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC
Sourced from FDA AI listRadiologyLung Density Analysis
IMBIO LLC
Sourced from FDA AI listRadiologyO-arm O2 Imaging System
Medtronic Navigation, Inc
Sourced from FDA AI listanesthesiologyEndoTool SubQ
MONARCH MEDICAL TECHNOLOGIES
Sourced from FDA AI listResults powered by Typesense.