FDA clears SD-OCT floor stand

Fremont, CA-The FDA has granted 510(k) clearance to a new multi-directional rolling floor stand (iStand, Optovue) for universal positioning of a compact spectral-domain optical coherence tomography (SD-OCT) device (iVue, Optovue).

The system enables eye-care professionals to follow patients from diagnosis through postoperative care. The stand is designed to expand the clinical utility of the SD-OCT device to enhance clinical decision-making, procedure planning, and documentation. By mounting the SD-OCT device onto the floor stand, clinicians can move the system between the exam lanes, hospital facilities, and satellite offices. The stand’s articulating arm is designed to facilitate scanning in the supine and other positions.

“The additional knowledge provided by the [SD-OCT] with [the stand] enhances control over procedural variability, resulting in greater predictability of results, and potentially reducing the rate of re-operations,” said Nalin Mehta, MD, who is in private practice at the Colorado Retina Center, Denver. Dr. Mehta said he has evaluated the system and found it useful in assessing the macula for epiretinal membranes, macular holes, and subclinical choroidal effusions.