Aurora AEYE FDA Process Update

15.11.2022

Optomed Plc Press Release 15 November 2022 at 16.00, Helsinki

Aurora AEYE FDA Process Update

Optomed and its partner AEYE Health have a common goal to obtain the US FDA clearance for the handheld AI fundus camera Aurora AEYE. Currently, the companies expect that they are able to address the latest feedback from the FDA in the coming months after which they will revert back to the agency.

Optomed announced the results from the prospective, multi-center clinical trial intended to assess its handheld fundus camera Aurora together with AEYE Health’s AI for autonomous detection of more than mild diabetic retinopathy in February 2022. Among patients positive for more-than-mild diabetic retinopathy, the combined product, Aurora AEYE detected 91.9 percent (sensitivity), while patients without the eye disease were correctly identified 93.6 percent of the time (specificity). The observed imageability was over 99 percent.

Optomed CEO, Seppo Kopsala, comments:

“We see an outstanding market opportunity for our hand-held fundus cameras combined with AI in the US market. AEYE Health has the latest high performing AI technology, and we are excited to be working with them towards our common goal.”

AEYE Health CEO, Zack Dvey-Aharon, Ph.D., comments:

“We are very excited for the opportunity to bring the first handheld AI fundus camera to the market US together with Optomed. The clearance process continues and we are committed to finalizing it as soon as possible.”

Optomed Plc

Further enquiries

Seppo Kopsala, CEO, seppo.kopsala@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.