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Eyenuk Inc., announces CE approval for new diabetic retinopathy screening tool

A relatively new company, Eyenuk Inc., based in Los Angeles, California, has announced the receipt of CE approval for a new diabetic retinopathy (DR) screening tool, trademarked “EyeArt”. The technology employs an automated screening system for high throughput image analysis of fundus photographs to rapidly and accurately diagnose DR. The technology is designed to overcome the limitations of current practice, which the company estimate may require up to 45 minutes per patient and specialist analysis of individual fundus images. According to the US-based research team at Eyenuk, the estimated 370M diabetic patients worldwide, a third of which will suffer DR, represent a significant logistical challenge for diagnoses, in relation to which, there is simply insufficient time or expertise to efficiently diagnose the growing number of patients.


At a recent ARVO meeting the company presented a poster evaluating the EyeArt tool in two large data sets in which colour retinal images, captured with standard fundus cameras, were analysed by specialist software. The company states that their high-throughput cloud based analysis is capable of processing 100,000 images per hour and may be capable of integration with existing clinician IT systems.


The company estimates that an estimated 592M people worldwide may have diabetes by 2035, with a significant number requiring retinal screening due to the increased risk of DR. Given the limited number of ophthalmologists, the company believes there are an insufficient number of eye-care providers to screen a large and growing number of patients. Consequently, the company suggests a scalable, high-throughput computerized DR screening algorithm and IT system to efficiently manage the increasing numbers. Commenting on the CE approval, Dr. Kaushal Solanki, CEO of Eyenuk stated that, “Receiving the CE Marking for our flagship screening product, EyeArt, is a significant milestone for Eyenuk. Our exhaustive research and patented image analysis technology behind EyeArt has culminated in a DR screening product that is more sensitive than human graders, while still reducing workloads by more than 50%.” Also commenting on the achievement, Dr. SriniVas Sadda of the Doheny Eye Institute stated, “I believe that an automated, reliable DR screening tool such as EyeArt would empower primary care providers to better manage their patients with diabetes. We continue to work with the company in supporting its clinical efforts here in the United States.”