The FDA has given 510(k) clearance to a normative database for a proprietary optical coherence tomography device (RTVue, Optovue).
Fremont, CA-The FDA has given 510(k) clearance to a normative database (NDB) for a proprietary optical coherence tomography (OCT) device (RTVue, Optovue), according to the company.
“This [clearance] affirms that our protocols and management of this large international, multi-site normative population are at the level that FDA regulatory guidelines require,” said Mike Sinai, PhD, senior director of clinical research for Optovue. “Most importantly, this [clearance] demonstrates the safety and efficacy of our NDB based on FDA current standard for its intended uses. This is the only NDB taking into account patient age, signal strength of scan, and even optic disc size in certain scan type.”
The NDB comprises more than 600 eyes for the pending U.S. release and is the largest FDA-cleared NDB for an OCT device, according to the company. Optovue plans to release the OCT application update containing the newly cleared NDB for customers soon.