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Compact OCT device receives 510(k) clearance
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FREMONT, Calif. — The iVue compact spectral-domain optical coherence tomography device from Optovue has received 510(k) clearance from the U.S. Food and Drug Administration, according to the company.
The device was launched outside the U.S. in January and was in high demand in the first quarter, Paul Kealey, vice president of marketing for Optovue, said in a press release.
"This regulatory clearance for the U.S. market allows us to offer the benefits of advanced OCT imaging to more segments within eye care, where the economic feasibility of the larger systems simply did not work," he said. "The iVue begins the next phase of the OCT revolution in the U.S. that started with the RTVue launch in 2006."
According to the release, the system works with a standard slit lamp base. It has a small scanning head, control module, laptop personal computer and foot switch.
"The iVue is the compact Fourier-domain version of the RTVue OCT, offering the same scanning speed and resolution as the larger system, that includes scanning and reports for retina, retina nerve fiber and cornea assessment by the clinician," the release said.
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