CenterVue EIDON Receives 510(k) FDA Clearance

The world’s first true-color confocal scanner cleared for sale in the United States

FREMONT, Calif. & PADOVA, Italy--()--CenterVue, a world leader in eye disease prevention using innovative imaging technologies, today announced FDA clearance for its EIDON true-color confocal scanner. EIDON is the first, fully-automated retinal imaging system available in the global eye care market that combines the advantages of confocal scanning with true-color imaging capabilities.

“We are excited to launch EIDON as a breakthrough innovation in retinal imaging”

EIDON's white-light, confocal imaging technology facilitates diagnosis and management of retinal disease. The combination of confocal imaging and white light illumination provides greater contrast and superior image quality over a traditional fundus camera. Furthermore, the retinal appearance with EIDON’s white-light source mirrors that as seen during white-light, direct observational techniques. EIDON’s optics allow imaging of the central retina as well as the periphery, over a viewing angle of up to 110 degrees. EIDON's multiple imaging modalities – true-color, red-free, and infrared - provide information concerning different layers of the retina.

Professor Giovanni Staurenghi, Eye Clinic Director at the University of Milano and Sacco Hospital, commented: “EIDON's combination of white illumination with confocal imaging provides better image quality. The confocal aperture provides sharp visualization of detail. Confocal white light technology allows us to obtain real color images through a small pupil. The infrared light images detect what the human eye is not able to see. What once was a dream, is now a reality!”

EIDON streamlines image acquisition and ensures minimum operator involvement by automatically aligning the patient's pupil, focusing on the retina, and capturing images using a soft light source. EIDON can be used automatically or manually, with or without pupil dilation. It is operated via a dedicated software application as a standalone unit by means of a high-resolution multi-touch tablet.

“We are excited to launch EIDON as a breakthrough innovation in retinal imaging,” commented William Burnham, Vice President of Sales and Marketing at CenterVue, Inc. "Eye Care Practitioners will be impressed with its sophisticated imaging capabilities and versatile clinical utility."

ABOUT CENTERVUE

CenterVue is a privately held company, headquartered in Padova, Italy, with a US subsidiary located in Fremont, CA. CenterVue develops diagnostic systems for the early detection of sight-threatening pathologies, such as Diabetic Retinopathy and Macular Degeneration. The company's goal is to reduce preventable blindness in diabetic and aging patients. CenterVue integrates the most advanced technologies to develop superior diagnostic instruments for eye care. With over 3000 installations worldwide, CenterVue's in-house research and product development have helped doctors, throughout the world, with the implementation of global screening programs for early detection of ocular pathologies and vision disorders.

Contacts

COMPANY CONTACT
CenterVue, Inc.
William Burnham, OD, 408-988-8404
VP, Sales and Marketing
william.burnham@centervue.com
OR
MEDIA CONTACT
Pascale Communications
Deb Holliday, 412-877-4519
deb@pascalecommunnications.com