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
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3D-Side SA
Sourced from FDA AI listRadiologyVolpara Imaging Software
Matakina Technology LTD
Sourced from FDA AI listCardiologyAtrial Fibrillation History Feature
Apple Inc.
Sourced from FDA AI listclinical_toxicologyBIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
BIO-RAD LABORATORIES, INC.
Sourced from FDA AI listRadiologyAV Vascular
Philips Medical Systems Nederland B.V.
Sourced from FDA AI listRadiologyCorInsights MRI
ADM Diagnostics, Inc.
Sourced from FDA AI listRadiologyTOMTEC-ARENA
TOMTEC Imaging Systems GmbH
Sourced from FDA AI listRadiologyContour ProtégéAI
MIM Software Inc.
Sourced from FDA AI listRadiologyOPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
Abbott Medical
Sourced from FDA AI listRadiologyAccipiolx
MaxQ-Al Ltd.
Sourced from FDA AI listRadiologyViz ICH
Viz.ai, Inc.
Sourced from FDA AI listRadiologyPowerLook Density Assessment V4.0
iCAD, Inc.
Sourced from FDA AI listRadiologySaige-Q
DeepHealth, Inc.
Sourced from FDA AI listlaboratory_medicineDreaMed Advisor Pro
DreaMed Diabetes Ltd
Sourced from FDA AI listlaboratory_medicineAccelerate Pheno System, Accelerate PhenoTest BC Kit
Accelerate Diagnostics, Inc.
Sourced from FDA AI listRadiologyuMI Panvivo
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyNeurophet AQUA AD Plus
Neurophet., Inc.
Sourced from FDA AI listRadiologyAquilion Serve SP (TSX-307B/1) V1.3
Canon Medical Systems Corporation
Sourced from FDA AI listNeurologyStealth AXiS Surgical System with Stealth AXiS Spine clinical application
Medtronic Navigation, Inc.
Sourced from FDA AI listCardiologyVivio® LVEDP System
Avicena, LLC
Sourced from FDA AI listRadiologyHyper Insight - ICH
SK Inc.
Sourced from FDA AI listRadiologyMI View&GO
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyMRCAT Head & Neck
Philips Oy
Sourced from FDA AI listRadiologyEFAI NeuroSuite CT ICH Assessment System
Ever Fortune.AI Co., Ltd.
Sourced from FDA AI listResults powered by Typesense.