Devices

FDA Approved Ortho BLA for Blood Grouping Reagents

FDA has approved an Ortho Clinical Diagnostics BLA for the Ortho Sera blood grouping reagents designed for extended phenotype testing with the ID-Micro Typing System Gel Card technology. “During pre-transfusion testing, labs routinely encounter patient samples that require extended antigen typing for blood group system antigens beyond those most commonly tested (A, B, D),” the company says. “These patients have developed atypical antibodies (i.e. K, Le [a] , Le [b] ), which require additional testing to find compatible blood. In the United States, pre-transfusion laboratories typically conduct extended antigen testing manually via tube testing.”

The Ortho Sera is designed to provide labs with a comprehensive menu of antisera for phenotyping available in a gel testing format, covering more than 99% of the most commonly tested blood group antigens, the company says. It also enables laboratories to have all testing performed on one system. ôMany blood banks use a combination of manual and automated testing in an effort to accommodate dynamic workloads, variable skill levels and budget constraints,” it says.

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