Optovue, the company that launched the first FDA cleared fourier/spectral domain OCT in the U.S., announced that it has received 510(k) clearance on its Normative Database (“NDB”) for the RTVue OCT device.
“This affirms that our protocols and management of this large international, multi-site normative population are at the level that FDA regulatory guidelines require,” stated Mike Sinai, PhD, Sr. Director of Clinical Research for Optovue. “Most importantly, this demonstrates the safety and efficacy of our NDB based on FDA current standard for its intended uses. Furthermore, this is the only normative database taking into account patient age, signal strength of the scan, and even optic disk size in certain scans. These factors along with the large normal sampling, offers clinicians a high degree of confidence in our NDB as a reference tool in assessing retina nerve fiber thickness.”
The NDB for the RTVue system comprises over 600 eyes for the pending U.S. release, and is the largest FDA cleared NDB for an OCT device. Optovue plans on releasing the RTVue application update containing the newly cleared NDB for customers in the next several weeks.
About RTVue and iVue
RTVue was the first FDA cleared Fourier domain (also known as spectral domain) OCT launched in the United States, and also the first OCT cleared by the U.S. Food and Drug Administration for both corneal and retinal imaging. The iVue is the compact fourier-domain version of the RTVue OCT, offering the same scanning speed and resolution as the larger system, that includes scanning and reports for retina, retina nerve fiber and cornea assessment by the clinician.
Source: Optovue Inc