Therapy Areas: Devices
FDA Grants Clearance to Optovue for OCTA Technology
13 June 2018 - - Fremont, California-based medical device company Optovue, Inc. has received US Food and Drug Administration (FDA) 510(k) clearance of AngioAnalytics, an optical coherence tomography angiography (OCTA) blood vessel measurement technology to help clinicians manage diseases that cause progressive blindness, the company said.
The company also received clearance for its three-dimensional projection artifact removal (3D PAR) software, which greatly improves OCTA image quality and enables accurate measurement and interpretation of OCTA images.
AngioAnalytics brings objective data and analysis to Optovue's AngioVue OCTA technology which allows for high-resolution imaging of retinal blood vessels to create color-encoded maps of the vessel densities of the retina or optic nerve, and provide analyses of areas where there is blood vessel loss, abnormal blood vessel growth, or change to the foveal avascular zone.
The new AngioAnalytics software also provides trend analysis so that physicians can objectively monitor retinal and vascular changes caused by disease progression or from treatment.
3D PAR technology is important to improving OCTA image quality, as it forms the basis for accurate qualitative image interpretation and reliable measurements that enable physicians to quickly document disease states and incorporate OCTA technology into their diagnostic armamentarium.
Privately held Optovue is dedicated to the advancement and commercialization of high-speed OCT and OCTA technology used to facilitate the diagnosis and management of eye diseases, many of which may lead to permanent blindness.
To date, there are over 400 peer-reviewed publications detailing the AngioVue Imaging technology and clinical applications.
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