Optos receives FDA clearance for microperimetry testing deviceApril 5, 2013
Optos announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Microperimetry as part of the OptosOCT SLO. Microperimetry assesses retinal sensitivity providing a precise correlation between structural pathology and corresponding visual functional defects. This data provides more clinical information to support the evaluation of patients’ vision.
The OptosOCT SLO is the only device on the market that can conduct structural OCT and functional Microperimetry testing. This combination makes it easier for eye care professionals to effectively assess treatment results. The Microperimetry test runs in conjunction with a high speed confocal (SLO) and provides real-time tracking of the retinal vessels, resulting in faster perimetry test times and more accurate change over time assessments, compared with standard perimetry. With today’s new treatments for retinal disease, eye care professionals require additional tools to effectively monitor the results of treatments. Microperimetry provides the eye care professional with the ability to test and quantifiably monitor changes of the patient’s retinal function in a selected location on the retina over time.
“We continue to strive to provide innovative technology to the market,” said Optos CEO Roy Davis. “With this 510(k) clearance for microperimetry, we once again offer a unique tool that allows eyecare professionals to see more, diagnose more and treat more diseases earlier. Further it supports our plans for a combined optomap and OCT in the future. This device represents the ‘dream team’ from a diagnostic perspective.”