Optovue Receives FDA Clearance of iCam

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iCam Non-Mydriatic Color Fundus Camera to be premiered at the Annual Heart of America meeting

Optovue, a pioneer in spectral-domain optical coherence tomography (SD-OCT), has received 510(k) clearance for its latest product, the iCam™ Non-Mydriatic, compact fundus camera. The iCam camera produces 45° color fundus images of the eye as well as external ocular structures. Even with its compact size, the iCam includes a variety of functions and features that produce high-quality image documentation and management of ocular health. A 12-bit CCD sensor is used to provide deep, rich colors with lower noise than typical 8-bit CMOS sensors used in competing cameras. An LED light source is used for reduced peak light energy to the eye as well as longer life.

“In our clinic, we believe that the clearance of iCam is a game changer, as it gives any clinician the opportunity to do high-quality, easy-to-use fundus photography of various pathologies,” says Jorge Cuadros, OD of Buena Vista Eyecare Group. “In addition, it has an economical pricing structure and unparalleled imaging capabilities with a learning curve that is minimal compared to that of other devices. iCam will provide a tremendous return on our investment.”

The device includes simple joystick control, focusing and positioning aids to expedite the photography process while an easy user interface enables image review and EMR communication.

iCam is expected to release to the US market in early Q2, followed by a global release.

About Optovue®
Optovue, Inc. is a privately-held ophthalmic device company dedicated to working with eye care professionals and clinical researchers to lead the commercialization of new imaging modalities that improve diagnosis and therapy of ocular disease. Optovue has achieved widespread market success through a combination of unique data analysis design, a reputation for excellent customer service, and rapid innovation of its technology in response to physician feedback. The company is headquartered in Fremont, California, with operations in Encinitas, California and European operations in Germany.

For more information, visit http://www.optovue.com.

Contact:

Paul Kealey
Sr. Vice President Marketing
paul_kealey(at)optovue(dot)com
510-623-8868 x105

Bill Jackson
Vice President Regulatory
bill_jackson(at)optovue(dot)com
510-623-8868 x205

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Paul Kealey
Optovue, Inc.
510-623-8868 105
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Bill Jackson
Optovue, Inc.
510-623-8868 205
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