Eyenuk's EyeArt automated high-throughput diabetic retinopathy screening receives CE Mark

Eyenuk, Inc. announced today that it received CE Marking for its pioneering EyeArt software, a suite of advanced image analysis tools for automated high-throughput screening of diabetic retinopathy. The company plans to launch its product in select leading eye care sites across Europe in the next few months.

Diabetic Retinopathy (DR), a common microvascular complication of diabetes, is the leading cause of blindness in the adult working-age population. The total annual economic burden of eye disorders and vision loss associated with diabetes is estimated at over $130 billion in the US alone. Early detection and treatment can reduce the number of people with vision loss caused by DR by up to 90%. But with over 350 million individuals living with diabetes worldwide, and expected to reach 500 million people by 2030, there are simply not enough eye care providers to serve the screening needs of this growing population. Automation of diabetic retinopathy screening is the only realistic method to screen a large proportion of those with diabetes. This screening will also significantly reduce healthcare costs and improve efficiency for ophthalmologists and other eye care specialists.

EyeArt provides a highly-scalable and cost-effective cloud-based DR screening solution that analyzes thousands of patients' eyes in just a few hours. Using color retinal images taken with standard fundus cameras, the software analyzes the high-resolution images of the retina, and uses this information to automate detection of diabetic retinopathy. By automating this process, EyeArt is designed to help healthcare professionals identify patients who need immediate attention in a more effective and efficient manner. Extensive clinical validation studies for EyeArt have shown that the product can achieve better sensitivity than human graders, while cutting the screening workload in half. EyeArt's cloud-based programming interface is expected to be made widely available in Europe and the US (pending FDA clearance), enabling quick and seamless integration into existing electronic medical or health record software.

"Receiving the CE Marking for our flagship screening product, EyeArt, is a significant milestone for Eyenuk," said Dr. Kaushal Solanki, CEO of 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%."

Members of the diabetes care community are also optimistic. Dr. Andrew Boulton, a renowned diabetes expert stated, "I am excited that EyeArt is soon to become available in Europe. Automated eye screening could have a huge impact in improving the lives of individuals with diabetes who still face the risk of losing vision asymptomatically."

Leading retina expert Dr. SriniVas Sadda from the Doheny Eye Institute agrees: "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."