Optomed Plc announced that it has on April 30, 2024 received information that AEYE-DS with Optomed Aurora has received a 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market and sell the AI camera. The capability to perform screening with just one image per eye and deliver results on-the-spot within 60 seconds showcases the product's user-friendly design and rapid diagnostic process. Commercialization is supported by already existing reimbursement code in the US and the fact that diabetic retinopathy screening in primary care may positively influence key healthcare metrics such as HEDIS scores.

Optomed will provide the Aurora AEYE screening solution as a service together with AEYE Health that enables the company?s clients to start using the solution without the burden of startup costs. This solution is expected to start the transformation of the company?s business into a recurring revenue model.