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