Optovue Receives FDA 510(k) Clearance of the RTVue XR FD-OCT

Optovue has announced it has received FDA 510(k) clearance of the XR version of its RTVue FD-OCT system, according to a news release (pdf).

Features of the updated XR version include 70,000 A-scans-per-second to spectral-domain OCT, real-time tracking and an updated SharpVue feature, according to the company. The speed of the RTVue XR is intended to help reduce the incidence of motion artifacts while allowing for greater scan averaging output.

"This FDA clearance affirms RTVue's position as the market leader, now with the fastest scan speed of any FDA cleared device available," said Jay Wei, CEO of Optovue, in the release. "We continue to leverage our experience in OCT product development and Fourier-domain technology to serve the needs of physicians and patients."

The RTVue XR was premiered at the American Society of Colon and Rectal Surgeons Symposium and Congress in Chicago and is scheduled to be available in the third quarter of 2012.

Optovue is based out of Fremont, Calif.

Related Articles on FDA Clearances:

GE Healthcare Receives FDA 510(k) Clearance for Latest Version of Vivid E9 Cardiovascular Ultrasound System

Smiths Medical Receives FDA 510(k) Clearance for ViaValve Safety IV Catheter

ActiViews Receives FDA 510(k) Clearance of CT-Guide Needle Guidance System for Liver Interventions

© Copyright ASC COMMUNICATIONS 2012. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.