OPTOMED RELEASES FIRST FDA-CLEARED HANDHELD AI FUNDUS CAMERA FOR DETECTION OF MORE THAN MILD DIABETIC RETINOPATHY

ATLANTA, May 1, 2024 /PRNewswire/ -- Optomed USA, Inc., a medical technology company, introduces the Optomed Aurora AEYE, a handheld AI fundus camera that provides instant detection of more than mild diabetic retinopathy. With the Optomed Aurora AEYE, diabetic patients in the primary care setting can now get on-the spot eye screenings and immediate retinopathy detection before being referred to an eye care professional.

Optomed Aurora with AEYE-DS is the only FDA-cleared handheld AI fundus camera. Recent clinical trials demonstrated that the Optomed Aurora AEYE handheld camera exhibits diagnostic sensitivity was in the range of 92%-93% and specificity was in the range of 89%-94%. In both studies, over 99% of patients received a diagnostic result. Its non-mydriatic and single image per eye operation offers quick and accurate screening. Its high-contrast optical design is engineered to detect small early-phase retinal changes with a 50-degree field-of-view. The ease-of-use is further increased by autofocus and auto exposure functions. It has the capability to capture digital images that can easily be sent to eye care providers.

Nearly 50% of the 38.4 million Americans who have diabetes skip their annual eye exams, leaving them vulnerable to diabetic retinopathy and blindness. Autonomous screening in primary care can improve clinic adherence to HEDIS measurements, is reimbursable, and ultimately can prevent blindness in diabetics at risk for vision loss.

"The Optomed Aurora AEYE gives primary care providers the opportunity to bridge the diabetic retinopathy gap in the US with immediate, on-the-spot detection of diabetic retinopathy with results in about 60 seconds," said David Frasch, Managing Director. "This technology removes the guesswork out of when it is necessary to refer a patient to an eye care provider. Results with the Optomed Aurora AEYE are simple: red means you refer to an eye care specialist, and green means you screen again in 12 months."

About Optomed
Optomed USA, Inc. a wholly owned subsidiary of Optomed Plc, a Finnish medical technology company and one of the leading providers of handheld fundus cameras worldwide. Optomed Plc combines handheld screening devices with software and optional artificial intelligence integration with the aim to transform the diagnostic process of blinding eye-diseases such as rapidly increasing diabetic retinopathy. In its business, Optomed Plc focuses on eye-screening devices and software solutions-related R&D in Finland, and sales through different channels in over 60 countries. 

Forward-Looking Statements
This press release includes forward-looking statements concerning future events. These statements involve risks and uncertainties, and actual results may differ from those expressed or implied. Factors beyond the control of Optomed Plc and its affiliates may affect future performance. Optomed Plc and its affiliates rely on third parties for certain activities, and delays may occur if these parties fail to meet obligations, regulatory requirements, or deadlines. Optomed Plc and its affiliates do not commit to updating forward-looking statements considering future events or changes in expectations.

Contact Information
Optomed USA, Inc.
Theresa Matson
626-437-5950
[email protected]

SOURCE Optomed USA Inc.