Eyenuk is committed to enabling autonomous retinal screening through artificial intelligence. Its product, EyeArt, is the first and only FDA 510(k)-cleared autonomous AI capable of simultaneously detecting more-than-mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) at the point of care.
Purpose Retinal imaging is the fastest and best way to non-invasively detect diabetic retinopathy (DR). Early detection through retinal screening can prevent 95% of vision loss caused by DR. Given that 1 in every 3 people with diabetes is affected by retinopathy, manual screening methods can no longer keep up with demand. Eyenuk's AI can identify key lesions, usually without the need for pupil dilation.
Key Capabilities EyeArt can detect more-than-mild and vision-threatening diabetic retinopathy within seconds through non-invasive retinal examination. Its performance metrics are: 96% sensitivity and 88% specificity for identifying mtmDR; 97% sensitivity and 90% specificity for identifying vtDR. The system supports autonomous examination at the point of care without the need for a specialist, delivering fast and accurate results. EyeArt is suitable for primary care, endocrinology, optometry, ophthalmology, and many other scenarios. It is compatible with multiple camera models from several mainstream camera manufacturers and can be used globally.
How It Is Used Eyenuk provides solutions from non-invasive retinal examination to clinical action. EyeArt supports FDA-cleared autonomous AI screening, rapidly identifies more-than-mild and vision-threatening DR, and systematically prioritizes high-risk patients for referral to specialists. The system centrally manages patients' clinical history for longitudinal analysis, providing specialists with the data needed for proactive long-term care at scale. Operationally, medical assistants can assist with completing autonomous screening, allowing specialists to focus on complex pathology and interventional treatment. The system provides real-time image quality feedback and can obtain definitive results for more than 90% of patients without pupil dilation, requiring dilation in only a small proportion of patients to achieve 99% certainty. Diagnostic reports are delivered within 10 seconds, support EHR integration, automatically pull orders from patient medical records, and synchronize diagnostic reports. On-demand analytics can track screening volume and pathology trends across clinical locations.
Applicable Scenarios The solution is suitable for primary care, endocrinology, optometry, ophthalmology, and other scenarios. It can be used to close HEDIS diabetic eye exam gaps during routine primary care visits, increase value-based care bonuses and CMS star ratings; bill at the point of care through CPT 92229 to generate immediate revenue; and improve by providing evidence of autonomous diagnosisRisk Adjustment Factor (RAF) score; and protect patient independence through proactive AI detection, reducing the personal and systemic costs of blindness. Eyenuk is also used in public DR screening programs in the Nordic countries, the German Diabetes Center, rural and remote communities in Canada, and multiple healthcare systems in the United States.
Limitations and Compliance EyeArt holds FDA 510(k) clearance and is the only autonomous AI that simultaneously detects mtmDR and vtDR. It has also received EU MDR Class IIb CE certification for autonomous detection of DR, AMD, and glaucomatous optic nerve damage. In terms of safety and compliance, the system complies with SOC 2 Type 2 certification, HIPAA, GDPR, and ISO 13485:2016 (MDSAP). Eyenuk's platform is a multi-disease platform, with future expansion to detection of AMD, glaucoma, and predictive biomarkers for systemic cardiovascular and neurological health.
Regarding details such as fees, pricing, and specific installation steps, the available information does not currently provide them.
