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Eyenuk Secures FDA Clearance for Additional Camera in Diabetic Retinopathy Detection

June 22, 2023

Eyenuk has received FDA clearance to utilize the Topcon NW400 retinal camera with its EyeArt AI system for automated detection of diabetic retinopathy (DR). This clearance complements the system's existing clearance for usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras.

The EyeArt v2.2.0 system is now the first and only FDA-cleared AI system approved for use with multiple retinal cameras from different manufacturers.

This clearance expands upon the system's initial FDA clearance in August 2020 as the first AI technology capable of detecting both more than mild and vision-threatening DR. Moreover, in the European Union, the EyeArt system holds the distinction of being the first and only AI system approved under MDR Class IIb for detecting 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 employed by numerous clinics, facilitating secure and dependable eye screening for more than 230,000 patients with diabetes and the number continues to rise.

"I am particularly thrilled about this clearance as it showcases our extraordinary commitment towards our mission to screen every eye in the world to ensure timely diagnosis of life- and vision-threatening diseases," said Kaushal Solanki, PhD, Founder and CEO of Eyenuk. "The EyeArt system can now be used with multiple camera models in the U.S., which significantly expands access for patients who can be screened in their primary care doctor's office for preventable blindness due to diabetes."

This recent FDA clearance for the EyeArt v2.2.0 system is supported by clinical data from a prospective multi-center clinical trial (ClinicalTrials.gov ID NCT04984200), which showcased outstanding performance with the Topcon NW400 cameras, as outlined below:

● More than mild DR detection: Achieved 94.4% sensitivity and 91.1% specificity.

● Vision-threatening DR detection: Demonstrated 96.8% sensitivity and 91.6% specificity.

Moreover, this clearance brings enhancements to the EyeArt system, including an upgraded image quality assessment module and Eyenuk's proprietary Real-Time Image Quality Feedback solution. These improvements elevate the usability of the EyeArt system, achieving best-in-class gradability (i.e., the percentage of patients with conclusive reports) without the necessity of dilation.

During the clinical trial, "conclusive EyeArt results were available for 90.4% of cases without needing dilation" for all camera models (Canon CR-2 AF, Canon CR-2 Plus AF, and Topcon NW400). Additionally, when a small fraction of cases required dilation following the quality feedback solution's recommendation, "conclusive EyeArt results were available for 99% of cases."

"I am excited that we are bringing several patient- and clinic-friendly product updates to the market through this clearance," said Malavika Bhaskaranand, Head of Regulatory and Clinical Affairs for Eyenuk. "Real-Time Image Quality Feedback can significantly improve the clinical workflows associated with diabetic eye exams, and achieving best-in-class gradability implies much better patient experience and saving of clinic staff time that otherwise would have been spent on dilation."

Eyenuk is set to present the recently cleared EyeArt system at the 83rd Annual Scientific Sessions of the American Diabetes Association (ADA 2023), taking place in San Diego, CA, from June 23 to 26. Attendees can witness live demonstrations of the system at booth #527.

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