Optovue accessory for portable SD-OCT device receives FDA clearance

Optovue (Fremont, CA)'s iStand, a multi-directional stand that enables universal positioning of the iVue spectral-domain optical coherence tomography (SD-OCT) system, received FDA 510(k) clearance in June.

The iStand delivers enhanced clinical decisions, procedure planning and documentation to the compact and portable iVue SD-OCT device. As a system, eye-care professionals can follow patients from diagnosis through post-op care, and can move their optical coherence tomography (OCT) between the exam lane, hospital facilities, and satellite offices. Its articulating arm facilitates scanning supine patients as well as patients in other positions.

Immediate applications include assessment of the macula for epiretinal membranes, macular holes and subclinical choroidal effusions. Other potential uses include evaluation of cataract surgery patients at risk for acute post-op cystic macular edema (CME). The iVue with iStand could assist in identifying which of these high-risk patients may benefit from aggressive perioperative pharmacologic treatment. Additonal anterior segment applications may include evaluation of surgical wound structure, corneal graft-host interface, and assessment of IOL positioning, says Nalin Mehta, MD, in private practice at the Colorado Retina Center in Denver.


Posted by Lee Mather

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