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
EyeLook Glaucoma
Digital Diagnostics
Sourced from FDA AI listEndoscopyCADU
Olympus Corporation (Odin Medical Ltd.)
Editorial summaryRadiation OncologyRayStation Deep Learning Segmentation
RaySearch Laboratories
Editorial summaryRadiologyAutomation Platform
Canon Medical Systems
Sourced from FDA AI listEndoscopySMARTIBD
Olympus Corporation (Odin Medical Ltd.)
Editorial summaryRadiologyPrognica DenseBreast AI
Prognica Labs
Sourced from FDA AI listOncologyFlywheel Oncology Planner
Flywheel
Sourced from FDA AI listDermatologyNia Eczema Coach
Nia Health
Sourced from FDA AI listPrimary CareBabylon Symptom Checker
eMed / Babylon Health
Sourced from FDA AI listCardiologyInVision Precision Cardiac Amyloid
InVision Medical Technology Corporation
Sourced from FDA AI listRadiologyMedian LCS (internal name) / eyonis LCS (trade name) (1.0)
Median Technologies
Sourced from FDA AI listCardiologyJewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati
Element Science, Inc.
Sourced from FDA AI listRadiologyTechCare Trauma
Milvue
Sourced from FDA AI listRadiologySegmentron Viewer
DGNCT, LLC
Sourced from FDA AI listRadiologyRT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT
Brainlab AG
Sourced from FDA AI listRadiologyAI-Rad Companion Organs RT
Siemens Healthcare GmbH
Sourced from FDA AI listRadiologyEFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
Ever Fortune.AI, Co., Ltd.
Sourced from FDA AI listRadiologyInfinitt PACS 7.0
Infinitt Healthcare Co.,Ltd.
Sourced from FDA AI listclinical_toxicologyPATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
PATHWORK DIAGNOSTICS, INC.
Sourced from FDA AI listRadiologyAnnalise Enterprise CXR Triage Trauma
Annalise-AI Pty Ltd
Sourced from FDA AI listRadiologySaige-Dx
DeepHealth, Inc.
Sourced from FDA AI listgastroenterology_urologyCADDIE
Odin Medical Limited
Sourced from FDA AI listRadiologyBriefCase-Triage
Aidoc Medical , Ltd.
Sourced from FDA AI listRadiologyARTAssistant
Manteia Technologies Co., Ltd.
Sourced from FDA AI listResults powered by Typesense.