FDA Clears Eyenuk’s Diabetic Retinopathy Screening System

The FDA has granted Eyenuk 510(k) clearance for its EyeArt screening system for diabetic retinopathy, a complication of diabetes that can lead to blindness.

The artificial intelligence-based system can detect the condition during patients’ regular eye exams and can generate a report in less than a minute after the images are sent to a cloud system for analysis.

The company said its screening technology has been successfully tested on more than 500,000 patients.