FDA clears Optovue database tool for SD-OCT system

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

Optovue (Fremont, CA) has received FDA 510(k) clearance for the Normative Database for the company's iVue spectral-domain optical coherence tomography (SD-OCT) system. The database provides analysis information to be used as a clinical reference to aid in the diagnosis and management of ocular health and disease, enhancing applications for retina, optic disc, and anterior segment.

The database provides quantitative comparisons of the retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to help evaluate 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. Symmetry and change analyses combined with normative comparisons supports confident patient evaluation and management.

The database is included with all iVue SD-OCT system purchases and a new software update will be provided for free to all current system owners on record. The update is expected to be made available in early March 2013.

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