FDA Clears Eyenuk's AI System for Diabetic Retinopathy Screening

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LOS ANGELES—Eyenuk Inc., a global artificial intelligence (AI) medical technology and services company and a leader in real-world applications for AI eye screening, has received the FDA’s 510(k) clearance (K200667) to market its EyeArt autonomous AI System for diabetic retinopathy, a leading cause of blindness among American adults, according to a recent announcement. EyeArt is indicated for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) in eyes of adults diagnosed with diabetes who have not been previously diagnosed with more than mild diabetic retinopathy.

EyeArt is the first FDA cleared autonomous AI technology that can detect both mtmDR and vtDR in one test, in primary care and eyecare settings. In addition, EyeArt is also the first FDA cleared autonomous AI technology that has diagnostic outputs for each eye of a patient.

“This is great news to over 30 million Americans living with diabetes, especially those who may have vision-threatening diabetic retinopathy. The EyeArt autonomous AI System can now enable safe, effective, and equitable diabetic eye screening at convenient point-of-care locations, with AI results available in less than 1 minute,” said Kaushal Solanki, PhD, founder and CEO of Eyenuk. “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.”

The EyeArt system is indicated for use with two models of fundus camera in the U.S., Canon CR-2 AF and Canon CR-2 Plus AF. Eyenuk plans to expand the list of EyeArt-compatible imaging devices, by leveraging Eyenuk’s deep expertise in device validation, clinical research, and regulatory process in markets around the world, the announcement noted.

Diabetic retinopathy (DR) is a common complication of diabetes. It is characterized by progressive damage to the blood vessels of the retina, the light-sensitive tissue at the back of the eye that is necessary for good vision. According to CDC, an estimated 4.1 million and 899,000 Americans are affected by retinopathy and vision-threatening retinopathy, respectively.

It is estimated that number of vision-threatening diabetic retinopathy patients around the world will reach 56.3 million by 2030. While DR screening is recommended for all diabetic patients, less than half get screened annually, even in the developed world.

EyeArt’s FDA clearance was based on analysis of EyeArt performance in participants enrolled at primary care and general ophthalmology sites during a period of time where enrollment was sequential and also during a period where sites were permitted to enrich the study population, according to the announcement.

The sequential enrollment allows for an unbiased representation of the U.S. diabetic population and provides the following topline results from this pivotal clinical trial:

• 96 percent sensitivity and 88 percent specificity for detecting mtmDR
• 92 percent sensitivity and 94 percent specificity for detecting vtDR
• All eyes with ETDRS level 43 or higher were correctly identified as mtmDR positive.

The study also showed that novice operators can be trained to obtain medical grade retinal images. Even at primary care centers where most operators did not have prior ophthalmic imaging experience, EyeArt had an imageability of 97 percent (i.e., disease detection results were provided for 97% of eyes that received a reading center grading). Moreover, a vast majority of participant eyes (90 percent) received disease detection results without needing dilation.