Devices

FDA Clears Applied BioCode Respiratory Pathogen Panel

FDA has cleared an Applied BioCode 510(k) for its BioCode Respiratory Pathogen Panel (RPP) for use on the BioCode MDx-3000 System. The RPP tests nasopharyngeal swabs for of the most common viruses and bacteria, including Influenza A and subtypes H1, H1N1 2009pdm and H3, Influenza B, respiratory syncytial virus A/B, parainfluenza virus Types 1, 2, 3, and 4, human metapneumovirus A/B, adenovirus, rhinovirus/enterovirus, coronavirus, Mycoplasma pneumoniae, Chlamydia pneumoniae, and Bordetella pertussis. Previously, FDA cleared the company’s 17-target BioCode Gastrointestinal Pathogen Panel (GPP). The MDx-3000 system allows users to run the RPP and GPP combo panels at the same time, according to the company.

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