12/04/2024 | Press release | Archived content
New FDA Clearance Makes Eyenuk Inc. the First Company with Multiple Cameras for AI Detection of Diabetic Retinopathy.
Eyenuk, the AI-driven digital health company, has made a leap forward in accessible diabetic eye care. Recently, Eyenuk's flagship EyeArt® AI system received FDA clearance to work with multiple retinal cameras, this makes EyeArt® the first and only FDA-cleared AI system capable of operating with multiple retinal cameras from different manufacturers.
This breakthrough allows more primary care clinics to screen patients with diabetes for diabetic retinopathy (DR) without needing eye dilation. Equipped with real-time image quality feedback and an upgraded assessment module, EyeArt delivers high-grade, conclusive results, bringing best-in-class convenience to both doctors and patients.
In Europe, the EyeArt system is similarly groundbreaking, being the only AI tool cleared under MDR Class IIb to detect DR, macular degeneration, and glaucoma in one test. Since its launch, EyeArt has screened over 230,000 patients globally, a significant step toward Eyenuk's mission of safeguarding vision worldwide. CEO Kaushal Solanki shares, "This clearance showcases our commitment to screen every eye and prevent blindness in those at risk."
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