Startup gets CE mark for diabetic retinopathy screening software, FDA up next

Fundus images that EyeArt analyzes--Courtesy of Eyenuk

Eyenuk has received a CE mark for its EyeArt software analysis tools to diagnose diabetic retinopathy. The software provides an automated screening for the disease, which typically is detected now after an ophthalmologist reviews retinal images. The startup plans to launch the product at some European sites in the next few months and is awaiting a potential FDA clearance.

The startup expects that EyeArt could be used to automatically screen a population for diabetic retinopathy. But Eyenuk is still in the early stages of corporate development. So far, it's gotten more than $3.5 million in grants from the National Institutes of Health. It's currently in the midst of raising a Series A round.

The cloud-based software analyzes color retinal fundus images, which are a common component of eye exams. The technology detects and examines lesions in the back of the eye resulting from diabetic retinopathy. The condition can be without symptoms or result in only mild vision problems, but it is the most common cause of blindness among working-age adults. Type 1 or Type 2 diabetics are vulnerable to the complication, which is associated with longtime diabetes and poorly controlled blood glucose levels.

EyeArt can analyze and screen hundreds of thousands of them within a few hours, according to the company. These images can be from any number of the wide variety of available fundus cameras. It can even be integrated into electronic medical records systems that contain existing images within patient records for analysis.

Andrew Boulton

"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," Dr. Andrew Boulton, a professor of medicine at the University of Manchester, said in a statement.

The company expects that its technology could make screening for diabetic retinopathy more accurate, widely available and less expensive. EyeArt can offer better sensitivity than human graders, while cutting the work load of screening roughly in half, according to the company.

"I believe that an automated, reliable DR (diabetic retinopathy) screening tool such as EyeArt would empower primary care providers to better manage their patients with diabetes," Dr. SriniVas Sadda from the Doheny Eye Institute said in a statement. "We continue to work with the company in supporting its clinical efforts here in the United States."

Sadda is an Associate Professor of Ophthalmology at the Keck School of Medicine at the University of Southern California. He is an advisor to Eyenuk, which was founded by Kaushal Solanki, an electrical engineer with a PhD in electrical and computer engineering from the University of California at Santa Barbara.

In addition to EyeArt, the startup also has an automated image-based biomarker for diabetes retinopathy risk assessment and monitoring that it calls EyeMark and EyeApp, which offers automated image analysis to screen for diabetic retinopathy using iPhone-based retinal cameras. EyeMark is based on an analysis of the appearance and disappearance rates of microaneurysms, which are related to the progression of diabetic retinopathy.

- here is the release