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
MAGNETOM Terra; MAGNETOM Terra.X
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyCINA-ASPECTS
Avicenna.AI
Sourced from FDA AI listNeurologySleepStageML
Beacon Biosignals, Inc.
Sourced from FDA AI listRadiologyEdgeFlow UH10
Edgecare Inc.
Sourced from FDA AI listRadiologyOverjet Caries Assist-Pediatric
Overjet, Inc
Sourced from FDA AI listRadiologyBoneMRI
MRIguidance B.V
Sourced from FDA AI listRadiologyAI-Rad Companion (Pulmonary)
Siemens Healthcare GmbH
Sourced from FDA AI listRadiologyMAGNETOM Cima.X Fit
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listgastroenterology_urologyEW10-EC02 Endoscopy Support Program
FUJIFILM Corporation
Sourced from FDA AI listNeurologyAutomatic Registration
Brainlab AG
Sourced from FDA AI listRadiologyRevolution Ascend Sliding
GE Hangwei Medical Systems Co., Ltd.
Sourced from FDA AI listNeurologyEpiMonitor
Empatica Srl
Sourced from FDA AI listanesthesiologyAurora
EnsoData
Sourced from FDA AI listRadiologyHealthFLD
Nano-X AI Ltd.
Sourced from FDA AI listRadiologyRapid ASPECTS (v3)
iSchemaView, Inc.
Sourced from FDA AI listRadiologySIGNA Champion
GE Healthcare (Tianjin) Company Limited
Sourced from FDA AI listRadiologyCEPHX- Cephalometric Analysis Software
Orca Dental AI LTD
Sourced from FDA AI listCardiologyHeartFlow Analysis
HeartFlow, Inc.
Sourced from FDA AI listRadiologyRapid MLS
iSchemaview Inc.
Sourced from FDA AI listRadiologyLungQ v3.0.0
Thirona BV
Sourced from FDA AI listRadiologyButterfly iQ3 Ultrasound System
Butterfly Network, Inc.
Sourced from FDA AI listRadiologyYSIO X.pree
Siemens Medical Solutions
Sourced from FDA AI listRadiologyART-Plan
TheraPanacea
Sourced from FDA AI listRadiologyMAGNETOM Sola; MAGNETOM Altea
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listResults powered by Typesense.