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
MAGENTIQ-COLO (ME-APDS)
Magentiq Eye, Ltd.
Sourced from FDA AI listNeurologyFelix NeuroAI System
Fasikl Incorporated
Sourced from FDA AI listRadiologyQP-Prostate® CAD
Quibim S.L.
Sourced from FDA AI listPathologyGENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
Geneseeq Technology Inc.
Sourced from FDA AI listRadiologyClarius Prostate AI
Clarius Mobile Health Corp.
Sourced from FDA AI listRadiologyStrokeSENS ASPECTS Software Application
Circle Cardiovascular Imaging Inc.
Sourced from FDA AI listgastroenterology_urologyHyperSnap Surgical System (HSS)
Hypervision Surgical
Sourced from FDA AI listRadiologyVent Creativity Knee v1.0 (Hermes)
Vent Creativity
Sourced from FDA AI listNeurologyNelli (Version 7.11)
Neuro Event Labs OY
Sourced from FDA AI listRadiologySalix Central
Artrya Limited
Sourced from FDA AI listRadiologyBoneMetrics (US)
Gleamer SAS
Sourced from FDA AI listRadiologyMedical Image Post-processing Software (uOmnispace.CT)
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyProstate MR AI (VA10A)
Siemens Healthcare GmbH
Sourced from FDA AI listRadiologyJLK-ICH
JLK, Inc.
Sourced from FDA AI listRadiologyANDI 2.0
Imeka Solutions, Inc.
Sourced from FDA AI listRadiologyOsteoSight Hip (v1)
Naitive Technologies Ltd
Sourced from FDA AI listRadiologyAllix5
Clairity, Inc.
Sourced from FDA AI listRadiologyTraumaCad Neo (1.1)
Brainlab Ltd.
Sourced from FDA AI listRadiologySubtleHD (1.x)
Subtle Medical, Inc.
Sourced from FDA AI listRadiologysyngo.CT LVO Detection
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyCogNet AI-MT+
Medcognetics, Inc.
Sourced from FDA AI listRadiologyScaida BrainCT-ICH (v1.0)
Mlhealth 360
Sourced from FDA AI listRadiologyBioTraceIO Vision (V1.7)
Techsomed Medical Technologies
Sourced from FDA AI listRadiologyProFound AI Software V3.0
iCAD Inc.
Sourced from FDA AI listResults powered by Typesense.