Optomed Oyj, AEYE Health say portable device to detect eye issues gets FDA nod

[May 01, 2024]  (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."

(Reporting by Steven Scheer; Editing by Jan Harvey)

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