Eyenuk, a leading global artificial intelligence (AI) digital health company specialising in AI Eye Screening and AI Predictive Biomarker, has obtained clearance from the U.S. Food and Drug Administration (FDA) for the use of the Topcon NW400 retinal camera with its EyeArt AI system. This clearance expands the capabilities of Eyenuk's flagship product, providing primary care clinics with more options for screening individuals with diabetes. The FDA clearance also includes Real-Time Image Quality Feedback and an upgraded image quality assessment module, ensuring best-in-class gradability (conclusive reports) without the need for eye dilation.
Eyenuk's clearance marks a significant milestone as the EyeArt v2.2.0 system becomes the first and only AI system approved by the FDA for use with multiple retinal cameras from different manufacturers. This clearance builds upon the EyeArt system's initial FDA clearance in August 2020, making it the first AI technology authorised to detect both more than mild and vision-threatening diabetic retinopathy (DR). In the European Union, the EyeArt system is the sole AI system approved under MDR Class IIb for the detection of DR, age-related macular degeneration, and glaucomatous optic nerve damage in a single test.
Since its introduction to global markets, the EyeArt system has been embraced by numerous clinics, facilitating safe and reliable eye screening for over 230,000 patients with diabetes and counting.
In addition to the clearance, the EyeArt system now features an enhanced image quality assessment module and Eyenuk's proprietary Real-Time Image Quality Feedback solution. These improvements enhance the system's usability and enable it to achieve top-notch gradability (i.e., the percentage of patients with conclusive reports) without requiring dilation.
Eyenuk's FDA clearance reinforces its position as a leader in AI-based eye screening and underpins the company's commitment to delivering advanced technologies that enable early detection of sight-threatening conditions.
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