December 7, 2020 – Eyenuk is pleased to announce that its EyeArt® AI System for autonomous diabetic retinopathy detection has been granted regulatory approval by INVIMA, the Colombian governmental regulatory agency that oversees healthcare.
Colombia has approximately 3 million people with diabetes and is one of the largest Latin American markets for diabetic eye testing.
This approval is another exciting regulatory milestone for the company in 2020, after the EyeArt System gained clearance from the United States Food and Drug Administration. The EyeArt System is CE-marked as a Class IIa medical device in the European Union and licensed by Health Canada.