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
Aquilion ONE (TSX-308A/TSX-306A) V2.0
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyAI-Rad Companion (Cardiovascular)
Siemens Medical Solutions U.S.A.
Sourced from FDA AI listRadiologyOverjet Caries Assist
Overjet, Inc.
Sourced from FDA AI listRadiologyMPXA-2000
Medipixel, Inc.
Sourced from FDA AI listRadiologyuSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite
Wuhan United Imaging Healthcare Co.,Ltd
Sourced from FDA AI listRadiologyEPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Philips Ultrasound, LLC
Sourced from FDA AI listRadiologyButterfly iQ/iQ+ Ultrasound System
Butterfly Network, Inc.
Sourced from FDA AI listRadiologyAquilion Precision (TSX-304A/4) V10.14 with AiCE
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyuMR 680
Shanghai United Imaging Intelligence Co., Ltd.
Sourced from FDA AI listRadiologyEPIQ Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
Sourced from FDA AI listCardiologyCARTO 3 EP Navigation System V8.4
Biosense Webster, Inc.
Sourced from FDA AI listRadiologyLunit INSIGHT MMG (v1.1.10)
Lunit, Inc.
Sourced from FDA AI listRadiologyAquilion Serve (TSX-307A/1) V1.2 with AiCE-i
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyVitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
Canon Medical Informatics, Inc.
Sourced from FDA AI listRadiologyXeleris V Processing and Review System
GE Healthcare
Sourced from FDA AI listanesthesiologyBelun Sleep System BLS-100
Belun Technology Company Limited
Sourced from FDA AI listRadiologySpectral Bone Marrow
GE Medical Systems, LLC
Sourced from FDA AI listRadiologyTruPlan Computed Tomography (CT) Imaging Software
Circle Cardiovascular Imaging, Inc.
Sourced from FDA AI listRadiologyMR Diffusion Perfusion Mismatch V1.0
Olea Medical
Sourced from FDA AI listRadiologyAplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
Canon Medical Systems Corporation
Sourced from FDA AI listNeurologyAlpha Control Liner System (ACLS)
Coapt
Sourced from FDA AI listRadiologyX1-FFR
Spectrawave, Inc.
Sourced from FDA AI listRadiologyqER-CTA (v1.0)
Qure.ai Technologies
Sourced from FDA AI listRadiologyAIBOLIT 3D+
Aibolit Technologies, LLC
Sourced from FDA AI listResults powered by Typesense.