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
RemedyLogic AI MRI Lumbar Spine Reader
Remedy Logic Inc.
Sourced from FDA AI listRadiologyNeuroICH
Neurocareai Inc.
Sourced from FDA AI listRadiologyInVision Precision LVEF (LVEF)
InVision Medical Technology Corporation
Sourced from FDA AI listRadiologyVEA Align
EOS imaging
Sourced from FDA AI listRadiologyEFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
Ever Fortune.AI Co., Ltd.
Sourced from FDA AI listRadiologyTranspara
ScreenPoint Medical BV
Sourced from FDA AI listRadiologyBriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device
Aidoc Medical , Ltd.
Sourced from FDA AI listRadiologyScanDiags Ortho L-Spine MR-Q
ScanDiags AG
Sourced from FDA AI listCardiologyAcumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure
Edwards Lifeciences, LLC
Sourced from FDA AI listRadiologyGenius AI Detection 2.0 with CC-MLO Correlation
Hologic, Inc.
Sourced from FDA AI listlaboratory_medicine23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
23andMe, Inc.
Sourced from FDA AI listNeurologyEmbrace
Empatica Srl
Sourced from FDA AI listRadiologyTranspara Density 1.0.0
Screenpoint Medical B.V.
Sourced from FDA AI listRadiologyNvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
NinePoint Medical, Inc.
Sourced from FDA AI listRadiologyV8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listlaboratory_medicineFluChip-8G Influenza A+B Assay
InDevR, Inc.
Sourced from FDA AI listdentalMATRx plus
Zephyr Sleep Technologies
Sourced from FDA AI listRadiologyQOCA image Smart CXR Image Processing System
Quanta Computer Inc.
Sourced from FDA AI listRadiologyInferRead CT Stroke.AI
Infervision Medical Technology Co., Ltd.
Sourced from FDA AI listRadiologyTeraRecon Cardiovascular.Calcification.CT
Terarecon,Inc.
Sourced from FDA AI listCardiologyCorVista System with PH Add-On
Analytics for Life, Inc.
Sourced from FDA AI listRadiologyAdravision Perio
Adra Corporation
Sourced from FDA AI listRadiologyLVivo Software Application
DiA Imaging Analysis Ltd.
Sourced from FDA AI listRadiologyLibby Echo:Prio
Dyad Medical, Inc
Sourced from FDA AI listResults powered by Typesense.