EyeArt AI system approved in EU for detecting AMD, glaucomatous optic nerve damage
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The EyeArt AI eye screening system has been approved for marketing in the European Union for detecting age-related macular degeneration and glaucomatous optic nerve damage, according to a press release from Eyenuk.
The system was previously approved for diabetic retinopathy screening in the EU, making it the first autonomous AI solution with Class IIb Medical Devices Regulations CE marking for the detection of signs of diabetic retinopathy, AMD and glaucomatous optic nerve damage in patients at risk for vision loss, the release said.
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The device uses retinal imaging cameras to detect all three diseases in a single exam with the same set of retinal images and can generate a detailed screening report within 30 seconds.
“This [European Commission] certification multiplies our impact in two ways,” Kaushal Solanki, CEO and founder of Eyenuk, said in the release. “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.”
The EyeArt AI system received FDA clearance for diabetic retinopathy screening in 2020.
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