London: A portable device that detects eye diseases that can cause vision loss in people with conditions such as diabetes has received approval from the US health regulator, say its developers Optomed Oyj and AEYE Health.
“I am pleased to announce that our Optomed Aurora handheld fundus camera with AEYE artificial intelligence has received FDA clearance,” Optomed CEO Juho Himberg said in a statement Tuesday. “This milestone represents a significant advancement in health care technology.”
During the minute-long procedure, the device takes images from each eye using a special camera, then uses artificial intelligence to record and analyze data on the retina to assist diagnose diseases, including diabetes, that can cause blindness.
The latest Food and Drug Administration approval will enable autonomous screening anywhere using the Aurora portable handheld device, U.S.-Israeli company AEYE Health said in a statement Wednesday.
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Screening of diabetics for retinopathy is currently reimbursed in the United States.
AEYE says more than 500 million people worldwide are at risk of diabetic retinopathy, which is considered the leading cause of blindness in the working-age population.
“This is the ‘Holy Grail’ of eye screening – fully autonomous artificial intelligence, using portable or tabletop retinal cameras, and the procedure takes a minute,” Zack Dvey-Aharon, co-founder and CEO of AEYE Health.
“We believe this innovation will prevent millions of people from going blind in the U.S. and around the world.” (Reporting by Steven Scheer; Editing by Jan Harvey)
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