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 1,358FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1358 devices
BrainInsight
Hyperfine, Inc.
Sourced from FDA AI listRadiologyAVIEW RT ACS
Coreline Soft Co.,Ltd
Sourced from FDA AI listRadiologyCogNet QmTRIAGE
MedCognetics, Inc.
Sourced from FDA AI listRadiologyMR Contour DL
GE HealthCare
Sourced from FDA AI listRadiologyAnnalise Enterprise CTB Triage Trauma
Annalise-AI Pty Ltd
Sourced from FDA AI listRadiologyMedian LCS (internal name) / eyonis LCS (trade name) (1.0)
Median Technologies
Sourced from FDA AI listCardiologyInVision Precision Cardiac Amyloid
InVision Medical Technology Corporation
Sourced from FDA AI listRadiologyLVivo IQS
DiA Imaging Analysis Ltd
Sourced from FDA AI listRadiologyAutoContour Model RADAC V2
Radformation, Inc.
Sourced from FDA AI listRadiologyLVivo Seamless
DiA Imaging Analysis Ltd.
Sourced from FDA AI listRadiologyNeosoma Brain Mets
Neosoma, Inc.
Sourced from FDA AI listRadiologyAutoContour (RADAC V5)
Radformation, Inc.
Sourced from FDA AI listRadiologySegmentron Viewer
DGNCT, LLC
Sourced from FDA AI listRadiologyV8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
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 listRadiologyScaida BrainCT-ICH (v1.0)
Mlhealth 360
Sourced from FDA AI listRadiologyBunkerhill Abdominal Aortic Quantification (AAQ)
BunkerHill Health
Sourced from FDA AI listRadiologyBrainomix 360 Triage ICH
Brainomix Limited
Sourced from FDA AI listRadiologyProstatID
ScanMed, LLC
Sourced from FDA AI listRadiologyClearRead Xray Pneumothorax
Riverain Technologies, Inc.
Sourced from FDA AI listCardiologyIRNF App
Apple Inc.
Sourced from FDA AI listRadiologyStrokeSENS LVO
Circle Neurovascular Imaging, Inc
Sourced from FDA AI listRadiologyBriefCase, RIB Fractures Triage (RibFx)
Aidoc Medical, Ltd.
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 listResults powered by Typesense.