Optomed Aurora with AEYE has received FDA clearance in the US

Inside information: Optomed Aurora with AEYE has received FDA clearance in the US

Optomed Plc Inside Information 30 April 2024 at 16.00, Helsinki

Optomed is pleased to announce that it has today 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.

“I’m thrilled to announce that our Optomed Aurora handheld fundus camera with AEYE’s AI has received FDA clearance. This milestone marks a significant advancement in healthcare technology as Aurora AEYE is the first handheld AI screening solution to obtain FDA clearance. We expect this to revolutionize patient care and diagnosis of diabetic retinopathy, the leading cause of vision loss in working-age adults.

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.

I would also like to extend our gratitude to AEYE Health for steering the regulatory process in professional manner. Optomed will provide the Aurora AEYE screening solution as a service together with AEYE Health that enables our clients to start using the solution without the burden of startup costs. This solution is expected to start the transformation of our business into a recurring revenue model.” CEO Juho Himberg says.

Zack Dvey-Aharon, Ph.D., Co-Founder and CEO of AEYE Health comments: ”We’re thrilled to be receiving the first-ever FDA clearance for a portable AI screening solution, and we extend our appreciation to Optomed. Their unwavering collaboration and shared vision have been instrumental in this remarkable achievement. Together we have demonstrated the power of partnership and innovation in advancing healthcare technology for the betterment of all. This is a true game-changer, and we cannot be more excited to see Aurora AEYE in market.”

The Company’s future outlook remains as-is at this point but Optomed continues to assess the outlook as the sales and marketing of the new solution proceed.

Optomed expects its full year 2024 revenue to grow compared to 2023.


Optomed Plc

Further enquiries

Juho Himberg, CEO, juho.himberg@optomed.com


Optomed in Brief

Optomed is a Finnish medical technology company and a leading manufacturer of handheld fundus cameras and screening software. Optomed combines handheld fundus cameras with software and artificial intelligence with the aim to transform the diagnostic process of various diseases, such as rapidly increasing diabetic retinopathy. Optomed has offices in Finland, the US and China and the company’s products are sold via various sales channels in over 60 countries globally