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www.fdanews.com/articles/168994-centervue-gets-fda-nod-for-true-color-confocal-scanner

CenterVue Gets FDA Nod for True-Color Confocal Scanner

December 9, 2014

CenterVue Tuesday announced the launch of its Eidon true-color confocal scanner following FDA 510(k) clearance. The device is the first retinal imaging system to combine confocal scanning with true-color imaging capabilities, according to the Fremont, Calif., firm.

The fully automated Eidon’s combination of confocal imaging technology and white light illumination provides superior contrast and image quality over a traditional fundus camera, simplifying the diagnosis of retinal diseases, CenterVue says.

The scanner allows for both central and outer retinal imaging, providing a viewing angle of up to 110 degrees, and its multiple imaging methods — true color, red-free and infrared — yield information on different layers of the retina, the company notes.

Only minimal operator involvement is required, as Eidon automatically aligns the patient’s pupil, focuses on the retina and captures the images, CenterVue adds. The system can be used automatically or manually, with or without pupil dilation, and is operated via an app on a high-resolution tablet. — Kellen Owings

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