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
SIGNA Artist Evo
GE Healthcare(Tianjin) Company Limited
Sourced from FDA AI listCardiologyEko Analysis Software
Eko Devices Inc
Sourced from FDA AI listRadiologyPowerLook® Tomo Detection Software
iCAD Inc
Sourced from FDA AI listRadiologyEPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
Philips Ultrasound, Inc.
Sourced from FDA AI listRadiologyNS-HGlio
Neosoma Inc.
Sourced from FDA AI listNeurology7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
7D Surgical Inc.
Sourced from FDA AI listRadiologyDeepXray
Alpha Intelligence Manifolds, Inc.
Sourced from FDA AI listRadiologySaige-Density (2.5.0)
DeepHealth, Inc
Sourced from FDA AI listRadiologyHALO
NICo-Lab B.V.
Sourced from FDA AI listRadiologyScreenDx
Imvaria, Inc
Sourced from FDA AI listRadiologyV5med Lung AI
V5med Inc.
Sourced from FDA AI listRadiologyBrainomix 360 e-CTA
Brainomix Limited
Sourced from FDA AI listRadiologyClearPoint Maestro Brain Model
ClearPoint Neuro, Inc.
Sourced from FDA AI listCardiologyAHI System
Fifth Eye Inc.
Sourced from FDA AI listRadiologyCoLumbo
Smart Soft Healthcare AD
Sourced from FDA AI listRadiologyMVision AI Segmentation
MVision AI
Sourced from FDA AI listRadiologyVBrain
Vysioneer Inc.
Sourced from FDA AI listRadiologyViewFinder Software Version 1.1
Elaitra Ltd
Sourced from FDA AI listCardiologyDEEPVESSEL FFR
KeyaMed NA Inc.
Sourced from FDA AI listRadiologyLunit INSIGHT CXR Triage
Lunit Inc.
Sourced from FDA AI listOrthopedicsPrecision AI Surgical Planning System (PAI-SPS)
Precision AI Pty, Ltd.
Sourced from FDA AI listRadiologyImagine® Enterprise Suite
Softlink International Private Limited
Sourced from FDA AI listRadiologyAI-Rad Companion Brain MR
Siemens Healthcare GmbH
Sourced from FDA AI listPathologyGenius Digital Diagnostics System with the Genius Cervical AI algorithm
Hologic Inc.
Sourced from FDA AI listResults powered by Typesense.