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
Saige-Density
DeepHealth, Inc.
Sourced from FDA AI listRadiologySyngo Dynamics (Version VA40F)
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listanesthesiologyVISIONAIR
PacificMD Biotech Llc
Sourced from FDA AI listRadiologysyngo.via RT Image Suite
Siemens Medical Solutions USA Inc.
Sourced from FDA AI listCardiologyCorvair Monza
AliveCor, Inc.
Sourced from FDA AI listRadiologyUltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyAI Platform (AIP001)
Exo Inc
Sourced from FDA AI listRadiologyLOGIQ Totus
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listRadiologyLiverMultiScan v5 (LMSv5)
Perspectum
Sourced from FDA AI listRadiologyAorta-CAD
Imagen Technologies, Inc
Sourced from FDA AI listRadiologyMAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyHS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listRadiologyQFR (3.0)
QFR Solutions bv
Sourced from FDA AI listRadiologyABMD Software
HeartLung Corporation
Sourced from FDA AI listRadiologyVivid E80, Vivid E90, Vivid E95
GE Medical Systems Ultrasound and
Sourced from FDA AI listNeurologySafeOp 3: Neural Informatix System
Alphatec Spine, Inc.
Sourced from FDA AI listRadiologyTeraRecon Neuro
TeraRecon, Inc
Sourced from FDA AI listRadiologyLibby Echo:Prio
Dyad Medical, Inc
Sourced from FDA AI listRadiologySonio Suspect
Sonio
Sourced from FDA AI listRadiologysyngo.CT Extended Functionality
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyVivid T8, Vivid T9
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Sourced from FDA AI listRadiologyVivid iq
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
Sourced from FDA AI listRadiologyElucidVivo A.3
Elucid Bioimaging Inc.
Sourced from FDA AI listRadiologyVenue
GE Medical Systems
Sourced from FDA AI listResults powered by Typesense.