Optovue Receives FDA Clearance of Normative Database for iVue SD-OCT

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iVue Normative Database delivers more meaningful clinical analyses

Optovue, a pioneer in spectral-domain optical coherence tomography (SD-OCT), has received FDA 510(k) clearance of the Normative Database for the iVue SD-OCT system. The Normative Database provides analysis information to be used as a clinical reference to aid in the diagnosis and management of ocular health and disease. The addition of this diagnostic tool enhances iVue’s comprehensive suite of clinical applications for retina, optic disc, and anterior segment.

The iVue Normative Database provides quantitative comparisons of the retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to aid the practitioner in the evaluation of various ocular pathologies. After scans are captured, the normative comparison analysis adjusts for the patient’s age, optic disc size (for optic nerve head scans only), and scan signal strength, a feature that is unique to Optovue. Symmetry and change analyses combined with normative comparisons supports confident patient evaluation and management.

The Normative Database is included with any iVue SD-OCT system purchase and a new software update will be provided free-of-charge to all current iVue owners of record. This update is expected to be made available in early March.

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, please contact:

Paul Kealey
Sr. VP Marketing
510.623.8868 x105

Bill Jackson
VP Regulatory
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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