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
Brainscope Ahead 200
BRAINSCOPE COMPANY, INC.
Sourced from FDA AI listRadiologyHealthCXR
Zebra Medical Vision, Ltd.
Sourced from FDA AI listRadiologyEzra Plexo Software
Ezra AI Inc.
Sourced from FDA AI listNeurologyEyeBOX
Oculogica, Inc.
Sourced from FDA AI listNeurologyAhead 300
BRAINSCOPE COMPANY INC
Sourced from FDA AI listRadiologyLigence Heart
Ligence Uab
Sourced from FDA AI listRadiologyClarius OB AI
Clarius Mobile Health Corp.
Sourced from FDA AI listCardiologyViz HCM
Viz.ai, Inc.
Sourced from FDA AI listRadiologyLiverSmart
Resonance Health Analysis Services Pty Ltd
Sourced from FDA AI listRadiologyInferRead Lung CT.AI
Beijing Infervision Technology Co.,Ltd.
Sourced from FDA AI listRadiologyEFAI RTSUITE CT HCAP-Segmentation System
Ever Fortune.AI Co., Ltd.
Sourced from FDA AI listRadiologyWRDensity by Whiterabbit.ai
Whiterabbit.ai Inc.
Sourced from FDA AI listRadiologyCDM Insights
Oxford Brain Diagnostics Ltd
Sourced from FDA AI listRadiologyCINA-VCF
Avicenna.AI
Sourced from FDA AI listRadiologyEz3D-i /E3
Ewoosoft Co., Ltd
Sourced from FDA AI listRadiologyVELYS Hip Navigation
Depuy Ireland UC
Sourced from FDA AI listRadiologyVoluson SWIFT; Voluson SWIFT+
GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC
Sourced from FDA AI listRadiologyOverjet Dental Assist
Overjet, Inc.
Sourced from FDA AI listCardiologyAnalytic for Hemodynamic Instability (AHI)
Fifth Eye Inc.
Sourced from FDA AI listNeurologyNuVasive Pulse System
NuVasive, Incorporated
Sourced from FDA AI listRadiologyImagio Breast Imaging System
Seno Medical Instruments, Inc.
Sourced from FDA AI listRadiologyRevealAI-Lung
Precision Medical Ventures, Inc. Dba Revealdx
Sourced from FDA AI listRadiologyViz AAA
Viz. ai, Inc.
Sourced from FDA AI listRadiologySubtleMR (2.3.x)
Subtle Medical Inc.
Sourced from FDA AI listResults powered by Typesense.