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The U.S. Food and Drug Administration has granted Optos 510k clearance for microperimetry as part of the company's OptosOCT SLO, allowing for structural OCT and functional microperimetry testing within one instrument.
Marlborough, MA-Optos announced that 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 correlation between structural pathology and corresponding visual functional defects.
According to the company, the OptosOCT SLO is the only device that can conduct structural OCT and functional microperimetry testing. 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.
Optos’ CEO Roy Davis said, “We continue to strive to provide innovative technology to the market. 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.”