Compact SD-OCT granted FDA clearance

June 9, 2010

A proprietary spectral-domain optical coherence tomography (SD-OCT) device (iVue, Optovue) has received FDA 510(k) clearance.

Fremont, CA

-A proprietary spectral-domain optical coherence tomography (SD-OCT) device (iVue, Optovue) has received FDA 510(k) clearance.

The device was launched outside the United States in January and is a compact version of the company's other SD-OCT device (RTVue), which was introduced in the United States in 2006.

"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," said Paul Kealey, vice president of marketing for Optovue.

The new device's system is delivered on a standard slit lamp-style base and is composed of a 4.5-lb scanning head, a control module, laptop computer, and foot switch. The system can be mounted to a small table, and additional options for mounting in other eye-care environments may be available soon.

The compact device offers the same scanning speed and resolution as the larger system and includes scanning and reports for retina, retina nerve fiber, and cornea assessment by the clinician.