Optovue, Inc. (Fremont, CA, USAt) has announced that the new iVue compact SD-OCT has received U.S Food and Drug Administration (FDA) 510(k) clearance on April 29, 2010. "The iVue compact SD-OCT was officially launched outside the United States in January of this year, and we have seen very high demand--as expected--in the first quarter,” stated Paul Kealey, vice president of marketing for Optovue. "This 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.”

The iVue compact SD-OCT system is delivered on a standard slit lamp style base and is comprised of a small scanning head (2.2 kg), a control module, laptop personal computer (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.

RTVue was the first FDA-cleared Fourier domain (also known as spectral domain) OCT launched in the United States, 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 evaluation by the clinician.

Optovue is an ophthalmic device company focused on working with eye care professionals and clinical researchers to lead the commercialization of new imaging modalities that improve diagnosis and therapy of ocular disease.

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