Optomed Aurora with AEYE has received FDA clearance in the US

Optomed Plc, a leading medical technology company, has achieved a significant milestone with the FDA clearance for its innovative product, the AEYE-DS with Optomed Aurora. This handheld AI screening solution is designed to revolutionize retinal imaging and diagnostics.

Key Features

  • FDA 510(k) Clearance:

The Optomed Aurora with AEYE has received a 510(k) clearance from the U.S. Food & Drug Administration (FDA). This regulatory approval allows Optomed to market and sell the AI camera in the United States.

  • First-of-Its-Kind AI Screening Solution:

The Aurora AEYE stands out as the first handheld AI screening solution to obtain FDA clearance. Its compact design and ease of use make it a game-changer in the field of ophthalmology.

  • Single-Image Screening:

With just one image per eye, the Aurora AEYE performs comprehensive screening for conditions such as diabetic retinopathy. This efficiency streamlines the diagnostic process and reduces patient wait times.

  • Rapid Results:

Within 60 seconds, the Aurora AEYE delivers results, allowing healthcare professionals to make informed decisions promptly. Real-time analysis enhances patient care and ensures timely interventions.

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 the market‘, commented Zack Dvey-Aharon, Ph.D., Co-Founder and CEO of AEYE Health.

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 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 multiple sales channels in over 60 countries globally.

Source: Optomed