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Eyenuk receives CE mark for second-generation diabetic retinopathy screening software
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Eyenuk has received a CE mark for EyeArt 2.0, the company’s second-generation automated diabetic retinopathy screening software, according to a press release.
EyeArt 2.0 is scheduled to be launched at selected eye care centers throughout Europe over the next few months. Positive study results support the technology, showing 91% overall screening sensitivity for detecting referable diabetic retinopathy patients with specificity of 90.8%.
The study included 469,953 real-world color retinal fundus images from 59,005 consecutive diabetic patient visits, which were captured by a telemedicine program for diabetic retinopathy screening called EyePACS.
EyeArt 2.0 provides imaging, grading and reporting for diabetic retinopathy in accordance with internationally recognized standards including the U.K.’s NHS Diabetic Eye Screening Programme and the International Clinical Diabetic Retinopathy Disease Severity Scale.