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Optovue receives FDA clearance for RTVue XR
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FREMONT, Calif. — Optovue has received 510(k) clearance from the U.S. Food and Drug Administration for its updated XR version of the RTVue Fourier-domain optical coherence tomography system, the company announced in a press release.
The RTVue XR premiered at the American Society of Cataract and Refractive Surgery meeting in Chicago. It is scheduled to be available in the third quarter of 2012.
The update allows 70,000 A-scans per second and offers real-time tracking and an updated SharpVue feature, which reduces the incidence of motion artifacts and enables greater scan averaging output, according to the release. The update also offers 5-µm resolution; pachymetry mapping; keratoconus analysis; retina and glaucoma scanning and analysis functions; and high-magnification imaging of the cornea, angle and anterior crystalline lens.
The RTVue measures posterior corneal power directly rather than requiring good preoperative vision or a complete clinical record, the release said.