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 1,272FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1272 devices
Ventripoint Medical System Plus (VMS+) 4.0
Ventripoint Diagnostics Ltd.
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 listCardiologyAcumen Assisted Fluid Management (AFM) Software Feature
Edwards Lifesciences, LLC
Sourced from FDA AI listRadiologyDeepContour (V1.0)
Wisdom Technologies., Inc.
Sourced from FDA AI listRadiologyEFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
Ever Fortune.AI, Co., Ltd.
Sourced from FDA AI listRadiologyDrAid for Radiology v1
VinBrain Joint Stock Company
Sourced from FDA AI listRadiologyGenius AI Detection 2.0
Hologic, Inc.
Sourced from FDA AI listRadiologyV8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listRadiologyEchoPAC Software Only / EchoPAC Plug-in
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listRadiologyAI-Rad Companion Organs RT
Siemens Medical Solutions U.S.A.
Sourced from FDA AI listRadiologyBrainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)
Brainlab AG
Sourced from FDA AI listRadiologySynapse 3D Base Tools (V7.0)
FUJIFILM Corporation
Sourced from FDA AI listRadiologysyngo Dynamics (Version VA41D)
Siemens Healthcare GmbH
Sourced from FDA AI listRadiologyEFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
Ever Fortune.AI, Co., Ltd.
Sourced from FDA AI listRadiologyCaption Interpretation Automated Ejection Fraction Software
Caption Health, Inc
Sourced from FDA AI listanesthesiologyPMD-200
Medasense Biometrics Ltd.
Sourced from FDA AI listPathologyGenius Digital Diagnostics System with the Genius Cervical AI algorithm
Hologic Inc.
Sourced from FDA AI listRadiologySpine CAMP (1.1)
Medical Metrics, Inc.
Sourced from FDA AI listRadiologyLVivo IQS
DiA Imaging Analysis Ltd
Sourced from FDA AI listRadiologyAutoContour Model RADAC V3
Radformation, Inc.
Sourced from FDA AI listRadiologyEzra Flash
Ezra AI, Inc.
Sourced from FDA AI listCardiologyCLEWICU System
Clew Medical Ltd.
Sourced from FDA AI listRadiologyEFAI RTSUITE CT HCAP-Segmentation System
Ever Fortune.AI Co., Ltd.
Sourced from FDA AI listRadiologyBrainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
Brainlab AG
Sourced from FDA AI listResults powered by Typesense.