Drugs

Bruker Daltonik Gains Marketing OK for C. auris Detection

FDA has allowed the de novo marketing for Bruker Daltonik’s Bruker Maldi Biotyper CA system for identifying C. auris. FDA says this is the first test to identify the emerging pathogen, which can cause serious infections in hospitalized patients. The expanded detection for the test system adds the its already-cleared uses for identifying 333 species or species groups, covering 424 clinically relevant bacteria and yeast species.

The device uses a technology known as matrix-assisted laser desorption/ionization mass spectrometry in combination with a reference organism database. “Microorganisms cultured from patient samples are ionized by the laser to produce an organism spectrum, which is matched to the reference organism database for proper identification,” the agency says.

FDA’s marketing decision was based on an evaluation of data showing that the “system can reliably identify C. auris 100% of the time,” according to the agency. “Risks associated with use of the system may include no identification or misidentification of a microorganism.”

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