CE Mark and Launch for Eyenuk’s Next Generation EyeArt™ Fully Automated Diabetic Retinopathy Screening Software

The Eyenuk, Inc., EyeArt™ fully automated diabetic retinopathy (DR) screening software has received CE Mark approval and will be rolled out to selected, leading eye care centers in Europe over the next few months, says the company.


Diabetic retinopathy is a blinding eye disease which can affect many of the 415 million diabetic patients worldwide. While vision loss due to DR is preventable if diagnosed early, the current number of eye care professionals cannot keep pace with the demand for annual screening, making DR the leading cause of blindness in working-age adults in the industrialized world. Experts have recognized that the only feasible way to address this issue is to efficiently expand DR screening in the primary care environment via computerized analysis.

Eyenuk, Inc., is a developer of advanced retinal image analysis solutions to identify eye disease. Its EyeArt 2.0 software provides fully automated DR screening in one short office visit, including imaging, grading, and reporting for DR in accordance with internationally recognized standards, such as the UK’s NHS Diabetic Eye Screening Programme (NDESP) and the International Clinical Diabetic Retinopathy Disease Severity Scale (ICDR). It has been tested on one of the largest data sets of patient cases of any available DR screening technology, in demanding, real world settings using images captured in everyday practice. The technology is designed to be flexible, working effectivity with a variety of imaging protocols used in screening setups.

The commercial launch is supported by a new study of the EyeArt 2.0 technology, which demonstrated 98.3 percent sensitivity in identifying potentially treatable patients with severe non-proliferative or proliferative DR, and/or the presence of surrogate markers for CSME. In the study, the overall screening sensitivity for detecting referable DR patients was 91 percent (95% CI: 90.5% – 91.6%) with specificity of 90.8 percent (95% CI: 0.957-0.961). The study was presented on June 25 at the EASDec 2016 Meeting.

The robust study encompassed 469,953 real world, color retinal fundus images from 59,005 consecutive diabetic patient visits captured by EyePACS, a large, well-established telemedicine program for diabetic retinopathy screening.

Company comments

“While a few commercial or academic automated screening approaches have achieved over 90 percent sensitivity, it has come at the significant expense of specificity,” said Eyenuk Chief Executive Officer Kaushal Solanki. “For the first time, we have a system that has clinically demonstrated over 90 percent in both sensitivity and specificity. With this milestone, we believe that EyeArt 2.0 is the most advanced DR screening technology currently available.”

Physician comments

“As diabetic eye complications are silent in their developing stages, screening and early detection of treatable lesions are essential, and have been shown in the UK to be effective in reducing visual loss,” said diabetes expert Professor Andrew Boulton, MD, DSc(Hon), FACP, FRCP, Professor of Medicine, University of Manchester, UK. “EyeArt has the potential to have a huge impact in improving lives of individuals with diabetes by helping us clinicians accurately identify at-risk patients, provide timely treatment, and prevent vision loss.”

EyeArt™ is a trademark of Eyenuk, Inc.

EyeArt has received the CE Mark and is commercially available in the European Union. In the United States, EyeArt is limited by federal law to investigational use only and is not available for sale.

Source: Eyenuk, Inc.


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