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Thursday, Mar 28, 2024

Regulators OK Eyenuk’s AI Software

Medical device company Eyenuk Inc. earlier this month announced U.S. Food and Drug Administration clearance to market its diabetic retinopathy detection software. Called EyeArt, the artificial intelligence system will be used by health care providers to detect mild to vision-threatening diabetic retinopathy, a complication of diabetes and leading cause of blindness among adults. “It’s taken many years. The first time we talked to the FDA was in 2015 — it has been a long road,” Dr. Kaushal Solanki, founder and chief executive of Eyenuk, told the Business Journal. “The key challenge was aligning with what the FDA on what kind of clinical study would be needed to prove that the system works.” Retinal images are scanned and checked against a database of other retinal images for the disease. Scans can also check for other diseases including glaucoma, age-related macular degeneration, risk of stroke, cardiovascular risk and Alzheimer’s disease, Eyenuk said. An autonomous version of the screening process will likely be covered by insurance starting next year, the Woodland Hills company said; results would not need to be interpreted by an ophthalmologist. “This is great news to over 30 million Americans living with diabetes, especially those who may have vision-threatening diabetic retinopathy,” Solanki said in a statement. “This historical FDA clearance is our first major milestone enabled by our prospective, multi-center pivotal clinical trial which took us years to plan and complete.” Moving ahead, the company will work to build its commercial team in-house, as well as partner witvh companies of varying sizes for commercialization, based on market segments, Solanki said. “The thinking goes, this is a novel technology so we do need our people to tell this story in the right way,” the chief executive explained. “At the same time, we are also partnering with giant companies for the right segments.” Such partnerships are expected to be finalized in the next couple months. “What I can tell you is that there is an extra alignment with the companies that build the cameras that work with our AI technology,” hinted Solanki. In May and June, respectively, the company announced partnerships with Wagner Macula & Retina Center in Virginia, as well as Devlyn Optical, which operates retail eye-glass locations in California and Texas. Both companies will use Eyenuk’s software services at their sites. A total of 942 individuals participated in Eyenuk’s clinical trial — screenings picked up the disease 97 percent of the time, the company said, and 90 percent of participants did not need eye dilation to get results. The system uses artificial intelligence to read retinal images and screen for diabetic retinopathy.

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