Eyenuk Secures First MDR Certification for EyeArt® AI Screening System in the EU

Eyenuk Secures First MDR Certification for EyeArt® AI Screening System in the EU

February 01, 2023
226 read

Eyenuk has received approval to market its EyeArt® AI eye screening system in the European Union for the new uses of detecting age-related macular degeneration (AMD) and glaucomatous optic nerve damage.

The EyeArt AI system (version 3.0) has received a new certification from the European Commission (EC) as a Class IIb medical device under the EU's Medical Devices Regulation 2017/745 ("MDR"). This system uses computerized analysis of retinal image data to identify diabetic retinopathy (DR) (including diabetic macular edema), AMD, and glaucomatous optic nerve damage in patients at risk of vision loss. Until now, the EU had certified the EyeArt AI system for the identification of DR, including diabetic macular edema.

The EyeArt AI system will now be able to diagnose all three eye disorders automatically using the same set of retinal images, making it the first and only autonomous AI solution with Class IIb MDR CE accreditation for Eyenuk customers in the EU.

The EyeArt AI system is also the first and only one to be FDA-cleared in the United States for the identification of DR, the main cause of blindness in working-age adults, as well as CE Marked for the detection of the three disorders.

By enabling automatic AI diagnosis and care coordination in primary care medical practices without the requirement for a specialist's assessment, the EyeArt AI system significantly increases the accessibility of vision-saving eye examinations.

The device can be used by clinical support professionals to provide a thorough screening report in less than 30 seconds and is integrated with retinal imaging cameras. Its capacity to identify many eye conditions with a single exam helps lessen vision loss from these blinding eye conditions in regions with limited access to eye care.

Kaushal Solanki, Chief Executive Officer and Founder of Eyenuk, commented, “This EC certification multiplies our impact in two ways. First, our autonomous AI can now help many more patients at risk of vision loss – the population at risk of AMD and glaucoma, particularly seniors, in addition to people with diabetes. Second, our AI system can now provide a more comprehensive report for each patient with detection results for three diseases compared to just one previously.”