iVue Normative Database gets 510(k) clearance

February 20, 2013

Optovue has received FDA 510(k) clearance for the Normative Database for the iVue spectral-domain optical coherence tomography (SD-OCT) system.

 

Fremont, CA-Optovue has received FDA 510(k) clearance for the Normative Database for the iVue spectral-domain optical coherence tomography (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 iVue Normative Database provides quantitative comparisons of the retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to aid in the evaluation of various ocular pathologies. After scans are captured, the normative comparison analysis adjusts for the patient’s age, optic disc size, and scan signal strength. Symmetry and change analyses combined with normative comparisons support 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 available in early March.

 

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