EyeArt
FDA-cleared autonomous AI for diabetic retinopathy screening
Company profile
Harnessing deep learning to prevent blindness
Company profile
Eyenuk, Inc. is a medical AI company that has developed EyeArt, the first and only FDA 510(k)-cleared autonomous artificial intelligence system for detecting vision-threatening diabetic retinopathy (vtDR) and more than mild diabetic retinopathy (mtmDR). The company's mission centers on preventing blindness through early detection, as retinal screening can prevent 95% of vision loss caused by diabetic retinopathy. Eyenuk's platform provides a comprehensive solution spanning screening, triage, and monitoring of retinal diseases. The EyeArt system delivers diagnostic results in under 10 seconds without requiring patient dilation or immediate specialist oversight, making it ideal for deployment in primary care, endocrinology, optometry, and ophthalmology settings. The platform achieves 96% sensitivity and 88% specificity for identifying mtmDR, and 97% sensitivity and 90% specificity for identifying vtDR. Beyond diabetic retinopathy, Eyenuk has expanded its capabilities to detect age-related macular degeneration (AMD) and glaucomatous optic nerve damage, with Class IIb CE mark clearance in the EU. The system integrates seamlessly with existing EHR systems and is compatible with multiple retinal camera models from major manufacturers. Eyenuk serves health systems, primary care clinics, specialty practices, and screening programs globally, helping providers close care gaps, generate revenue through CPT 92229 billing, improve quality metrics like HEDIS and CMS Star Ratings, and enhance Risk Adjustment Factor (RAF) scores through accurate disease documentation.
Company description Eyenuk, Inc. official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Cloud Saas · Hybrid · Other deployment with recorded integration context.
Recorded integration context: EyePACS database, fundus cameras.
Company milestones
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
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
FDA-cleared autonomous AI for diabetic retinopathy screening
Autonomous AI detection of diabetic retinopathy, AMD, and glaucoma from retinal images
AI-powered detection of age-related macular degeneration
AI-powered detection of glaucoma from retinal imaging
AI system to accurately track retinopathy progression over time
Longitudinal disease monitoring with centralized clinical history
Lesion analysis in ultra-widefield retinal images
AI-powered triage and expert review platform for diabetic eye disease
AI-powered eye screening service for healthcare providers
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
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
Comparison of diabetic retinopathy severity grading on ETDRS 7-field versus ultrawide-field assessment.Eye (London, England) · Oct 1, 2023
Artificial Intelligence Detection of Diabetic Retinopathy: Subgroup Comparison of the EyeArt System with Ophthalmologists' Dilated Examinations.Ophthalmology science · Mar 1, 2023
Clinical validation
No linked records are currently available.
Regulatory
K223357 · 510k · Jun 16, 2023
EyeArtK200667 · 510k · Aug 3, 2020
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Pivotal clinical trial
Pivotal clinical trial
Pivotal clinical trial
Pivotal clinical trial
Pivotal clinical trial
Real-time screening
World's first national health system deployment of autonomous AI eye screening technology
First national-scale deployment of autonomous AI eye screening
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
Large scale validation of EyeArt AI system for diabetic retinopathy screening
Validated on over 100,000 patient encounters
Efficient diabetic retinopathy screening in primary care clinics and rural locations
Placed Eyenuk cameras in 20 rural primary care locations throughout Nebraska through grant funding to ensure annual screenings
Lower cost patient engagement in primary care and improved specialist referral efficiency
Reduced number of normal eye exams and improved matching of patients needing specialist care
Early identification of retinal disease in asymptomatic individuals
Enabled earlier intervention, better outcomes, and vision preservation through routine diabetes care integration
Improved efficiency and quality of care through autonomous DR screening
Reduced reliance on manual grading, lowered costs, and simplified workflows since 2020 adoption
05 · Leadership
Leadership profiles and professional links from the current Company record.
06 · Company updates
Recent articles published on Eyenuk, Inc.'s official website.
07 · HAIC coverage
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Curated official destinations from the active Company record.
09 · Market pathway
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
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.
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