Optovue, a provider of spectral-domain optical coherence tomography (SD-OCT), announces that it has received FDA 510(k) clearance of the XR version of its flagship RTVue FD-OCT system. Bringing 70,000 A-scans-per-second to spectral-domain OCT, the updated XR version offers clinicians speed which Optovue says no currently cleared SD-OCT system can match.
Together with real-time tracking and the updated SharpVue feature, the speed of the RTVue XR can reduce the incidence of motion artifacts while allowing for greater scan averaging output. This results in up-close tissue detail of the retina and choroid layers of the eye. Premiering at the ASCRS in Chicago, RTVue XR is scheduled to be available in the third quarter of 2012.
“This FDA clearance affirms RTVue’s position as the market leader, now with the fastest scan speed of any FDA cleared device available,” says Jay Wei, CEO of Optovue. “We continue to leverage our experience in OCT product development and Fourier-domain technology to serve the needs of physicians and patients.”
RTVue was the first FDA cleared Spectral-Domain OCT launched in the United States, and also the first OCT cleared by the US Food and Drug Administration for both corneal and retinal imaging. The RTVue provides an all-in-one solution for posterior and anterior high-speed, high-resolution OCT imaging, offering five-micron resolution, high-magnification imaging of the cornea, angle and anterior crystalline lens, pachymetry mapping, keratoconus analysis, as well as retina and glaucoma scanning and analysis functions.
The RTVue can be used to calculate the total power of the cornea in eyes that have undergone corneal refractive surgery, with Optovue’s proprietary corneal segmentation algorithm. Furthermore, the RTVue directly measures posterior corneal power and does not rely on good preoperative vision or a complete clinical record.
