AEYE Health gets FDA approval to screen diabetics to prevent blindness

JERUSALEM, Nov 15 (Reuters) - Israeli digital health firm AEYE Health said on Tuesday it received clearance from the U.S. Food and Drug Administration (FDA) 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 last February.

Using a special desktop camera, AEYE takes images from each eye and through artificial intelligence it captures and analyses 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.

(Reporting by Steven Scheer)

((; +972 2 632 2210; Reuters Messaging:; Twitter: @StevenMScheer))

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

More Related Articles

Info icon

This data feed is not available at this time.

Sign up for Smart Investing to get the latest news, strategies and tips to help you invest smarter.