EyeArt AI Eye Screening System
Autonomous AI detection of diabetic retinopathy, AMD, and glaucoma from retinal images
Software · HybridCompany source
Company profile
About Eyenuk, Inc.
Eyenuk is a global AI medical technology company and the leader in real-world AI Eye Screening for autonomous disease detection.
Company description Eyenuk, Inc. official website
Primary marketMedical Imaging & Radiology
Commercial modelCommercial information available on request
Work at Eyenuk, Inc.?
Claim this listing Claim this profile to manage Company information and connect with the Health AI Central audience.
01 · Operating footprint
Where the Company operates
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Clinical focus
- Age-related Macular Degeneration
- Diabetic Retinopathy
- Glaucoma
Who it serves
- Diabetologists
- Educators
- Endocrinologists
- Insurers
- Nurses
- Ophthalmologists
- Optometrists
- Payors
- Physicians
- Primary care clinics
Deployment & integration
Cloud Saas · Hybrid · Other deployment with recorded integration context.
Recorded integration context: EyePACS database, fundus cameras.
Geographic context
MarketsCanada · Denmark · European Union · United States
Company sourceOfficial website
Company milestones
Platform expansion
World's first national health system deployment in Denmark (Sept 2025), FDA clearance for multiple cameras (June 2023), EU MDR certification for DR, AMD, and glaucoma (Jan 2023), new CEO and Chairman appointments (Jan 2025)
Partnerships
Recorded partners
- Doheny Eye Institute
- FDA
- National Eye Institute
- National health system deployment in Denmark
- University of Illinois at Chicago
- University of Manchester
- Washington University School of Medicine
02 · Flagship portfolio
Products, workflows, and platform capabilities
Selected source-backed Company products and the available commercial context.
EyeArt for AMD Detection
AI-powered detection of age-related macular degeneration
Software · HybridCompany source
EyeArt for Glaucoma Detection
AI-powered detection of glaucoma from retinal imaging
Software · HybridCompany source
EyeMark
AI system to accurately track retinopathy progression over time
Software · OtherCompany source
EyeRead UWF
Lesion analysis in ultra-widefield retinal images
Software · OtherCompany source
Eyescreen Service
AI-powered eye screening service for healthcare providers
Service · Cloud SaaSCompany source
03 · Research intelligence
Research Intelligence evidence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Evidence position
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Publications & preprints
Predicting progression to proliferative diabetic retinopathy using automated versus manual quantification of retinal haemorrhages.Eye (London, England) · Apr 1, 2026
Diabetic Retinopathy Screening Among Federally Qualified Health Center Patients Using Point-of-Care AI: DRES-POCAI: A Trial Protocol.JAMA network open · Oct 1, 2025
Comparison of Validity and Reliability of Manual Consensus Grading vs. Automated AI Grading for Diabetic Retinopathy Screening in Oslo, Norway: A Cross-Sectional Pilot Study.Journal of clinical medicine · Jul 7, 2025
A pilot cost-analysis study comparing AI-based EyeArt® and ophthalmologist assessment of diabetic retinopathy in minority women in Oslo, Norway.International journal of retina and vitreous · May 23, 2024
Pivotal Evaluation of an Artificial Intelligence System for Autonomous Detection of Referrable and Vision-Threatening Diabetic Retinopathy.JAMA network open · Nov 1, 2021
Diabetic Retinopathy Screening in Patients with Diabetes Using a Handheld Fundus Camera: The Experience from the South-Eastern Region in Hungary.Journal of diabetes research · Jan 1, 2021
Clinical validation
Clinical-trial records
Diabetic Retinopathy Screening Point-of-Care Artificial IntelligenceNCT06721351 · Sponsor · ACTIVE NOT RECRUITING
Assessment of EyeArt Performance With Retinal CamerasNCT04984200 · Sponsor · COMPLETED
Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular BiomarkersNCT04567745 · Sponsor · COMPLETED
Assessment of EyeArt Performance With Retinal Imaging DevicesNCT04302012 · Sponsor · COMPLETED
Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening ToolNCT03078231 · Sponsor · COMPLETED
Assessment of EyeArt as an Automated Diabetic Retinopathy Screening ToolNCT03112005 · Sponsor · COMPLETED
Regulatory
Regulatory records
EyeArt v2.2.0K223357 · 510k · Jun 16, 2023
EyeArtK200667 · 510k · Aug 3, 2020
04 · Company-reported outcomes
Outcomes and case studies
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
96% sensitivity for detecting more-than-mild DR
Pivotal clinical trial
88% specificity for more-than-mild DR
Pivotal clinical trial
97% sensitivity for vision-threatening DR
Pivotal clinical trial
90% specificity for vision-threatening DR
Pivotal clinical trial
98% imageability
Pivotal clinical trial
Results in under 60 seconds
Real-time screening
Denmark National Health System
World's first national health system deployment of autonomous AI eye screening technology
First national-scale deployment of autonomous AI eye screening
University of Illinois at Chicago
Pivotal, prospective, multi-center clinical trial for diabetic retinopathy detection
96% sensitivity and 88% specificity for more-than-mild DR; 97% sensitivity and 90% specificity for vision-threatening DR; 98% imageability
EyePACS
Large scale validation of EyeArt AI system for diabetic retinopathy screening
Validated on over 100,000 patient encounters
05 · Leadership
Leadership team
Leadership profiles and professional links from the current Company record.
06 · Company updates
Updates from Eyenuk, Inc.
Recent articles published on Eyenuk, Inc.'s official website.
Eyenuk Secures World’s First National Health System Deployment of Autonomous AI Eye Screening Technology
Read on Eyenuk, Inc.September 17, 2025Eyenuk Secures World's First National Health System Deployment of Autonomous AI Eye Screening Technologyread article
Read on Eyenuk, Inc.Eyenuk Appoints Mads Dall as Chairman of the Board and Gaurav Agarwal as Chief Executive Officer
Read on Eyenuk, Inc.January 6, 2025Eyenuk Appoints Mads Dall as Chairman of the Board and Gaurav Agarwal as Chief Executive Officerread article
Read on Eyenuk, Inc.Eyenuk Supports Federal Efforts to Promote Nationwide Adoption of Interoperable Standards for Ophthalmic Imaging Data
Read on Eyenuk, Inc.07 · HAIC coverage
Coverage and analysis
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Company sources and channels
Curated official destinations from the active Company record.
09 · Market pathway
Additional Companies in this Market
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Medical Imaging & Radiology
Companies that apply AI to analyze medical images for diagnostic purposes, workflow optimization, or clinical decision support. Covers general radiology (X-rays, CT scans, MRIs, ultrasounds) across multiple organ systems, as well as specialized imaging in ophthalmology and dermatology.
Explore the full market directory or compare this Company with additional active profiles.
View all Companies in this market
10 · Pro research
Coming soon
Expanded Company research is in development.
Health AI Central Pro · Coming Soon
Deeper Company research is coming soon.
Pro Research will introduce expanded technical context, linked evidence analysis, and comparative Company research.
Linked research, clinical, and regulatory source pathways.
Expanded product, deployment, integration, and partnership research.
Record-level provenance and review context.