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
JBS-LVO
JLK, Inc.
Sourced from FDA AI listRadiologyTranspara (2.1.0)
ScreenPoint Medical B.V.
Sourced from FDA AI listRadiologySaige-Dx
DeepHealth, Inc
Sourced from FDA AI listRadiologyProFound Detection (V4.0)
iCAD, Inc.
Sourced from FDA AI listRadiologyTeraRecon Cardiac.Chambers.MR (1.0.0)
TeraRecon,Inc.
Sourced from FDA AI listRadiologyRemedyLogic AI MRI Lumbar Spine Reader
Remedy Logic Inc.
Sourced from FDA AI listRadiologyNeuroICH
Neurocareai Inc.
Sourced from FDA AI listRadiologyEFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
Ever Fortune.AI Co., Ltd.
Sourced from FDA AI listRadiologyInVision Precision LVEF (LVEF)
InVision Medical Technology Corporation
Sourced from FDA AI listOphthalmologyNotal Vision Home Optical Coherence Tomography (OCT) System
Notal Vision Inc
Sourced from FDA AI listRadiologysyngo.CT Brain Hemorrhage
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyFractureDetect (FX)
Imagen Technologies, Inc.
Sourced from FDA AI listRadiologySee-Mode Augmented Reporting Tool, Thyroid (SMART-T)
See-Mode Technologies Pte. Ltd.
Sourced from FDA AI listRadiologyGenius AI Detection 2.0 with CC-MLO Correlation
Hologic, Inc.
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 listlaboratory_medicineFluChip-8G Influenza A+B Assay
InDevR, Inc.
Sourced from FDA AI listNeurologyEmbrace
Empatica Srl
Sourced from FDA AI listdentalMATRx plus
Zephyr Sleep Technologies
Sourced from FDA AI listlaboratory_medicine23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
23andMe, Inc.
Sourced from FDA AI listRadiologyTeraRecon Cardiovascular.Calcification.CT
Terarecon,Inc.
Sourced from FDA AI listRadiologyEFAI ChestSuite XR Pneumothorax Assessment System
Ever Fortune AI Co., Ltd.
Sourced from FDA AI listNeurologyEnsoSleep
EnsoData, Inc.
Sourced from FDA AI listRadiologyCardiac Guidance
Caption Health, Inc.
Sourced from FDA AI listResults powered by Typesense.