Ophthalmological-focused developer Optovue said yesterday it won FDA 510(k) clearance for its AngioAnalytics optical coherence tomography angiography blood vessel measurement tech designed to aid in managing disease that cause progressive blindness.
The Fremont, Calif.-based company said it also won clearance for its 3D projection artifact removal software, designed to improve OCTA image quality to allow for accurate measurements and interpretation of its OCTA images.
OptoVue touted that the newly cleared AngioAnalytics tech adds to its currently released AngioVue OCTA technology designed to provide high-resolution imaging of retinal blood vessels. The platform is intended to provide analysis of areas where there is blood vessel loss, abnormal blood vessel growth and other parameters needed to assess change to the foveal avascular zone.
“AngioAnalytics and 3D PAR are game changers because they ‘erase’ overlying inner retinal blood vessel artifacts allowing for better visualization and more accurate measurement of the outer retina and choroidal structures, essential in treating the abnormal blood vessel growth that leads to blindness for patients with wet age-related macular degeneration. In the past, we’ve relied on two-dimensional imaging to determine the presence or absence of fluid leaking from these abnormal vessels in the retina, and whether or not additional treatment is necessary with VEGF inhibitor drugs. My personal evaluation of AngioAnalytics suggests we now have another way to monitor or determine if additional treatment is necessary by documenting how the drug affects a specific CNV membrane in a specific patient, and how long that effect lasts,” Dr. Paul Tornambe of San Diego’s Retinal Consultants said in a prepared statement.
“We are thrilled to receive marketing clearance for our innovative AngioAnalytics technology as part of the AngioVue System to aid physicians in the early detection and management of sight-threatening eye diseases in the U.S.. Analytic 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. The information provided by AngioAnalytics may help to change the clinical management of diabetic retinopathy, age-related macular degeneration and other diseases that progressively cause blindness for millions of people. We will continue to advance AngioAnalytics as we believe quantification is the gateway to widespread and global adoption of OCTA,” founder & CEO Jay Wei
said in a press release.
Last August, OptoVue said it won FDA clearance for its epithelial thickness mapping software designed for quantitative measurements of the epithelial and stromal layers of the cornea.
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