Optovue receives three 510(k) clearances

Optovue has received 510(k) clearances from the FDA for its AngioAnalytics OCT angiography blood vessel measurement technology and for its 3-D projection artifact removal software, as well as expanded clearance for noncontact, quantitative measurements of the epithelial and stromal layers of the cornea, or epithelial thickness mapping, according to press releases.

AngioAnalytics offers objective data and analysis with the AngioVue OCTA technology by creating color-encoded maps of the vessel densities of the retina or optic nerve, while the 3-D PAR technology improves OCTA image quality, the release said.

“Analytical measurement tools will shift the treatment paradigm because they provide an objective measure of treatment efficacy, thereby enabling truly customized patient management and improved patient care,” Jay Wei, founder and CEO of Optovue, said in a press release.

Expanded clearance for the epithelial thickness mapping (ETM), which is now available on the Avanti widefield OCT system, adds a 9-mm ETM scan to the previously available 6-mm scan, allowing detection of epithelial irregularities in an area about 2.25 times the area of the 6-mm scan, a release said.

“Optovue’s ETM software is already changing the way physicians assess the cornea,” Qienyuan Zhou, PhD, vice president of clinical affairs at Optovue, said in a release. “With the new clearance, it may very well become an integral part of anterior segment eye exams in daily clinical practice. Expanding the ETM map to 9 mm provides physicians with a critically enlarged scan area for the evaluation of various corneal conditions and diseases.”