Devices

FDA Authorizes Roche MRSA Detection Test

FDA has authorized marketing of Roche Molecular Systems’ new diagnostic test based on bacterial viability and novel technology to detect methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization. An agency statement says the cobos vivoDX MRSA diagnostic test may allow healthcare professionals to evaluate patients for colonization with MRSA bacteria more quickly than traditional culture-based techniques when such testing is needed.

The test uses a new bacteriophage technology based on bioluminescence to detect MRSA from nasal swab samples in as little as five hours, compared to 24-48 hours for conventional culture, FDA says. It says that diagnostic tests that can more quickly and easily detect MRSA could benefit patient care and may help healthcare providers prevent the spread of MRSA.

FDA says it reviewed data from performance studies in which the cobas vivoDX MRSA test correctly identified no MRSA in 98.6% of samples that did not have MRSA present. The agency reviewed the test through the de novo premarket review regulatory pathway for low-to-moderate-risk devices of a new type. Along with the marketing authorization, FDA says it is establishing special controls for tests of this type, including requirements relating to labeling and design verification and validation to address certain risks, such as false positives.

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