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Optomed Oyj, AEYE Health say portable device to detect eye issues gets FDA nod
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Optomed Oyj, AEYE Health say portable device to detect eye issues gets FDA nod
May 1, 2024 3:48 AM

May 1 (Reuters) - A portable device that detects eye

conditions that can cause sight loss in people with conditions

such as diabetes has received clearance from the U.S. health

regulator, its developers Optomed Oyj and AEYE

Health said.

"I'm thrilled to announce that our Optomed Aurora handheld

fundus camera with AEYE's AI has received FDA clearance,"

Optomed CEO Juho Himberg said in a statement on Tuesday. "This

milestone marks a significant advancement in healthcare

technology."

In a procedure that takes a minute, the device takes images

from each eye using a special camera and through artificial

intelligence captures and analyses data on the retina to help

diagnose diseases including diabetes that could cause blindness.

The latest Food and Drug Administration clearance will allow

for autonomous screening anywhere using the Aurora portable

handheld device, U.S.-Israeli AEYE Health said in its statement

on Wednesday.

Screening diabetics for retinopathy is now reimbursable in

the United States.

AEYE said more than 500 million people globally are at risk

of diabetic retinopathy, which it called the leading cause of

blindness in the working age population.

"This is the 'holy grail' of eye screening - fully

autonomous AI, using either portable or tabletop retinal cameras

and a procedure that takes a minute to perform," Zack

Dvey-Aharon, co-founder and CEO of AEYE Health.

"We believe this innovation will prevent the blindness of

millions of people in the U.S. and around the world."

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