FDA/CDC

AEYE health gets FDA nod for retinopathy screening in diabetes patients


 

(Reuters) – Israeli digital health firm AEYE Health said on Nov. 15 it received clearance from the U.S. Food and Drug Administration to market its screening system to detect damage to the retina of the eyes in diabetics.

Screening diabetics for retinopathy, or damaged retinas, has recently become reimbursable in the United States.

The FDA approval follows positive Phase III clinical trial results from February 2021.

Using a special desktop camera, AEYE takes images from each eye and through artificial intelligence it captures and analyzes data of the retina that helps diagnose diseases, including diabetes, that could lead to blindness.

It noted that diabetic retinopathy is a leading cause of blindness in the working age and that 90% of such vision loss could be avoided with early detection and treatment.

AEYE added it was advancing a follow-on program for the screening of glaucomatous optic neuropathy and expects to initiate FDA pivotal trials soon.

Reuters Health Information © 2022

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