OptoVue wins FDA nod for AngioAnalytics tech

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 AngioAnalytic...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Imaging Optical/Ophthalmic Regulatory/Compliance Optovue Source Type: news