■ Eyenuk’s EyeArt AI vision screening system (version 3.0) has been granted a new European Commission (EC) certification as a Class IIb medical device under the European Union’s medical devices regulation 2017/745 (MDR). The system is intended to detect signs of glaucomatous optic nerve damage, diabetic retinopathy, and age-related macular degeneration, as well as to identify patients at risk of vision loss using computerized analysis of images of the retina. The system enables detection of these diseases in a single exam using the same set of retinal images. This EC certification makes the EyeArt AI system the first and only autonomous AI solution with Class IIb MDR CE marking for the automated detection of all 3 eye diseases.
Article
Eyenuk Gets First EU MDR for AI Detection of Glaucoma and Retinal Diseases
Glaucoma Physician
June 1, 2023
Vol Ophthalmology Management 27, Issue June 2023
Page(s): 9