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 1,304FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1304 devices
LiverMultiScan (LMSv3)
Perspectum Diagnostics Ltd
Sourced from FDA AI listOphthalmologyCLARUS
Carl Zeiss Meditec, Inc
Sourced from FDA AI listRadiologyMedian LCS (internal name) / eyonis LCS (trade name) (1.0)
Median Technologies
Sourced from FDA AI listRadiologyTruPlan
Circle Cardiovascular Imaging Inc.
Sourced from FDA AI listRadiologyiNtuition-Structural Heart Module
TeraRecon Inc.
Sourced from FDA AI listRadiologyAquilion ONE (TSX-305A/6) V8.9 with AiCE
Canon Medical Systems Corporation
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 listRadiologySurgicalAR
MEDIVIS, Inc.
Sourced from FDA AI listRadiologyMonaco RTP System (6.3)
Elekta Solutions AB
Sourced from FDA AI listCardiologyphysIQ Heart Rhythm and Respiratory Module
physIQ, Inc
Sourced from FDA AI listNeurologyCOMPLETE CONTROL System Gen2
Coapt, LLC
Sourced from FDA AI listanesthesiologyd-Nav System
Hygieia, Inc
Sourced from FDA AI listCardiologyStudy Watch
Verily Life Sciences LLC
Sourced from FDA AI listRadiologyMRCP+ v1.0
Perspectum Diagnostics Ltd
Sourced from FDA AI listRadiologyAmCAD-UO
AmCad BioMed Corporation
Sourced from FDA AI listRadiologyiSchemaView RAPID
iSchemaView, Inc.
Sourced from FDA AI listRadiologyLung Vision System
Body Vision Medical Ltd.
Sourced from FDA AI listCardiologyeMurmur ID
CSD Labs GmbH
Sourced from FDA AI listRadiologyBone VCAR (BVCAR)
GE Medical Systems SCS
Sourced from FDA AI listCardiologyLoop System
Spry Health, Inc.
Sourced from FDA AI listRadiologyQuantib ND
Quantib BV
Sourced from FDA AI listRadiologyvascuCAP
Elucid Bioimaging Inc.
Sourced from FDA AI listRadiologyCARA System
Cara Medical, Ltd.
Sourced from FDA AI listCardiologyCARTO 3 EP Navigation System V8.4
Biosense Webster, Inc.
Sourced from FDA AI listResults powered by Typesense.