Submitted by kBLASTER Team on
by Business Wire
FREMONT, Calif. & PADOVA, Italy--(BUSINESS WIRE)--CenterVue, a world leader in eye disease prevention using innovative imaging technologies, today announced FDA 510(k) 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.
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.
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