iVue Normative Database receives FDA clearance

February 15, 2013

Optovue has received FDA 510(k) clearance of the Normative Database for its iVue SD-OCT system. The Normative Database analyzes information to be used as clinical reference in the diagnosis and management of ocular health and disease.

Fremont, CA-Optovue Inc. has received FDA 510(k) clearance of the Normative Database for its iVue SD-OCT system. The Normative Database processes 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 the practitioner in evaluating 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 support patient evaluation and management.

The Normative Database is included with any iVue SD-OCT system purchase. A new software update will be provided free-of-charge to all current iVue owners of record.

The update is expected to be made available in early March.