Eyenuk Secures the First European Union MDR Certification for Autonomous AI Detection of DR, AMD, and Glaucoma

Eyenuk has been approved 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 been granted a new European Commission (EC) certification as a Class IIb medical device under the EU’s Medical Devices Regulation 2017/745 (MDR) and is intended to detect signs of diabetic retinopathy (DR) including diabetic macular edema; AMD; and glaucomatous optic nerve damage in patients at risk of vision loss using computerized analysis of images of the retina. The EyeArt AI system was previously approved in the EU for the detection of DR including diabetic macular edema.

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 three eye diseases and will allow Eyenuk customers in the EU to detect the diseases in a single exam using the same set of retinal images, according to Eyenuk. The EyeArt AI system is also the first and only system that is both CE mark approved for the detection of the three diseases as well as FDA-cleared in the United States for the detection of DR.

"The EyeArt AI system expands the availability of vision-saving eye screenings by making automated AI diagnosis and coordination of care possible in primary care medical practices without the need for a specialist’s review. The system is integrated with retinal imaging cameras and can be operated by clinical support staff to generate a detailed screening report in less than 30 seconds. In regions with limited access to ophthalmologists, its ability to detect multiple eye diseases with a single exam can help reduce vision loss from these blinding eye diseases," according to Eyenuk.

“Achieving MDR certification is a major milestone for Eyenuk and a result of our early adaptation to the more stringent requirements of the new regulation. It reaffirms the strong results from rigorous clinical validation of the EyeArt AI system," Malavika Bhaskaranand, Head of Regulatory and Clinical Affairs at Eyenuk, said in a company news release.