-

OcuSciences Secures EU CE Clearance and Expands European Presence with OcuMet Beacon Instruments

ANN ARBOR, Mich.--(BUSINESS WIRE)--OcuSciences, a medical device company developing advanced ocular imaging technologies to help clinicians better understand retinal dystrophies and other leading causes of blindness, today announced that it has received EU CE clearance for its OcuMet Beacon, a breakthrough diagnostic instrument designed to enhance the assessment of eye health.

“The growing adoption of our technology by leading ophthalmic clinical centers across Europe highlights its unique value and diagnostic potential to improve disease detection and management and particularly helpful in monitoring treatment."

Share

In conjunction with this regulatory milestone, OcuSciences has deployed OcuMet Beacons in leading medical centers across Europe and the United Kingdom, marking a significant step forward in its mission to transform eye care globally.

EU CE clearance confirms that the OcuMet Beacon meets the stringent health, safety, and environmental protection standards required for commercialization across the European Economic Area. This achievement underscores OcuSciences’ commitment to delivering innovative, reliable, and accessible imaging solutions that empower eye care professionals worldwide.

“Securing CE clearance is a major milestone for OcuSciences and reflects our dedication to advancing the standard of care in ophthalmology,” said Kurt Riegger, CEO of OcuSciences. “The growing adoption of our technology by leading ophthalmic clinical centers across Europe highlights its unique value and diagnostic potential to improve disease detection and management and particularly helpful in monitoring treatment.”

The initial installations span prominent research institutions, hospitals, and specialized ophthalmic centers in Germany, England, and Wales. Each site will integrate the OcuMet Beacon into its clinical studies and research programs, further validating the technology’s real-world impact and driving advancements in ocular imaging.

According to the World Health Organization, more than 2.2 billion people worldwide experience vision impairment, making earlier and more detailed assessment essential for effective treatment. By deploying the OcuMet Beacon, OcuSciences aims to equip clinicians with the tools needed to detect disease earlier and improve outcomes for patients around the world.

About OcuSciences, Inc.

OcuSciences, Inc., is a commercial-stage biotechnology company developing retinal imagers to identify the signatures of disease occurring in the retina for improved detection of disease. Its flagship product, the OcuMet Beacon, has been developed to automatically, rapidly, and non-invasively assess retinal markers of disease, in a patient’s eye. OcuSciences has shown preliminary clinical utility in a number of disease states, including diabetic retinopathy, glaucoma, and age-related macular degeneration. Learn more at www.ocusciences.com.

Contacts

For media inquiries or more information, please contact:
Kurt Riegger
(734) 623-9434
info@ocusciences.com

OcuSciences


Release Versions

Contacts

For media inquiries or more information, please contact:
Kurt Riegger
(734) 623-9434
info@ocusciences.com

More News From OcuSciences

OcuSciences Announces FDA Marketing Clearance of OcuMet Beacon in Retinal Health Assessment at ARVO

ANN ARBOR, Mich.--(BUSINESS WIRE)--OcuSciences, Inc., a leader in advanced ocular diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its flagship device, the OcuMet Beacon, proprietary, non-invasive tool for assessing retinal health. The indication for use of the OcuMet Beacon is a confocal scanning ophthalmoscope indicated for infrared (IR) and autofluorescence (AF) imaging of a human retina with or without the use of a mydriatic agent. The...

OcuSciences Welcomes Michael Patane, PhD, to its Board of Directors

ANN ARBOR, Mich.--(BUSINESS WIRE)--OcuSciences, a medical device company developing ocular imagers to detect early disease by assessing retinal metabolic activity, today announced the addition of Michael Patane, PhD, to its Board of Directors. Dr. Patane brings over 25 years of drug discovery and development experience, with a proven track record of leadership in startup, biotechnology and pharmaceutical companies. Many of these roles included ophthalmic product creation and development. Most r...

OcuSciences Announces Publication Showing Potential to Detect Retinal Diseases with High Sensitivity

ANN ARBOR, Mich.--(BUSINESS WIRE)--OcuSciences, a medical device company developing ocular imagers to detect early disease by assessing retinal metabolic activity, today announced a publication in Frontiers in Ophthalmology journal. By assessing the flavoprotein fluorescence in the retina with its flagship device, the OcuMet Beacon, these findings suggest that the novel FPF measure can detect retinal diseases with a high degree of sensitivity. This cross-sectional observational study, led by Ri...
Back to Newsroom