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FDA clears normative database for iVue SD-OCT

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Optovue has received 510(k) clearance from the U.S. Food and Drug Administration for a normative database that functions as a clinical reference for the iVue spectral-domain optical coherence tomography system, according to a company news release.

With the database, the system can adjust OCT scans based on the patient’s age, optic disc size and scan signal strength and allow for quantitative comparisons of the retina, retinal nerve fiber layer, ganglion cell complex and optic disc measurements.

The database will be included with new purchases of the iVue SD-OCT system. Current owners will receive the software update free of charge. The update should be available in early March, according to the release.