Updated OCT system gains 510(k) clearance

May 2, 2012

Optovue has received FDA 510(k) clearance for an updated version of its proprietary spectral-domain optical coherence tomography system (RTVue XR FD-OCT system).

Fremont, CA-Optovue has received FDA 510(k) clearance for an updated version of its proprietary spectral-domain optical coherence tomography system (RTVue XR FD-OCT system).

The new version increases the number of A-scans per second to 70,000. It is scheduled to be available in the third quarter of this year.

“This FDA clearance affirms [the proprietary OCT system’s] position as the market leader, now with the fastest scan speed of any FDA-cleared device available,” said Jay Wei, Optovue chief executive officer. “We continue to leverage our experience in OCT product development and Fourier-domain technology to serve the needs of physicians and patients.”

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