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Optovue Receives FDA Clearance For iVue SD-OCT

Optovue, a provider of fourier/spectral-domain optical coherence tomography (OCT), has received FDA 510(k) clearance for its new iVue compact SD-OCT.

Optovue said that the iVue compact SD-OCT system is delivered on a standard slit lamp style base and is comprised of a small scanning head (4.5 lbs / 2.2 kg), a control module, laptop PC and foot switch. The system can be mounted to a small table and may have other mounting options in the near future for other eye care environments.

Optovue claimed that the RTVue was the first FDA cleared Fourier domain (also known as spectral domain) OCT launched in the US, and also the first OCT cleared by the FDA, for both corneal and retinal imaging. 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.

Paul Kealey, vice president of marketing at Optovue, said: “The iVue compact SD-OCT was officially launched outside the US in January of this year, and we have seen very high demand as expected in the first quarter. The regulatory clearance for the US 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. The iVue begins the next phase of the OCT revolution in the US that started with the RTVue launch in 2006.”

Optovue is a privately-held ophthalmic device company providing commercialization of new imaging modalities that improve diagnosis and therapy of ocular disease.