Devices

FDA Clears Optovue’s Optical Blood Vessel Measurer

FDA has cleared an Optovue 510(k) for its AngioAnalytics, an optical coherence tomography angiography (OCTA) blood vessel measurement technology to help clinicians manage diseases that cause progressive blindness. The company also received 510(k) clearance for its three-dimensional projection artifact removal (3D PAR) software, which is designed to improve OCTA image quality and enable accurate measurement and interpretation of the images. “Combined, the two technologies 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 (non-perfusion), abnormal blood vessel growth (flow area), and several parameters to assess change to the foveal avascular zone, an area of the retina profoundly affected by diabetic retinopathy,” the company says. “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.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome