Eyenuk’s EyeArt System Gets EU Expanded Approval for Eye Diseases

The EU has granted expanded approval to Eyenuk’s EyeArt artificial intelligence (AI) eye screening system to include detection of age-related macular degeneration and glaucomatous optic nerve damage, a sign of glaucoma.

EyeArt uses a camera to take retinal images and analyzes those images, delivering detailed reports in less than 30 seconds, the company said.

The 3.0 version of the system is certified in the EU as a Class IIb medical device.

The system is also approved in the EU and FDA-cleared for detecting diabetic retinopathy.