FDA clears EyeArt AI system for diabetic retinopathy screening
Eyenuk has received 510(k) clearance from the FDA to market EyeArt, an autonomous AI system for diabetic retinopathy screening, according to a press release.
The system is designed to automatically detect more than mild diabetic retinopathy and vision-threatening diabetic retinopathy in adults with diabetes in one test. The system has diagnostic outputs for each of the patient’s eyes.
The clearance was based on a preregistered, prospective, multicenter pivotal clinical trial of 380 patients at seven primary care sites and 275 patients at four ophthalmology sites. Topline results found 96% sensitivity and 88% specificity for the detection of more than minor diabetic retinopathy and 92% sensitivity and 94% specificity for the detection of vision-threatening diabetic retinopathy.
The system is indicated for use with the Canon CR-2 AF and the Canon CR-2 Plus AF fundus cameras, with the company planning to expand the number of compatible imaging devices in the future.
According to the release, autonomous AI for diabetic retinopathy screening may be covered by payers beginning in 2021.