Devices

FDA Safety Alert on Sciex Mass Spectrometers

FDA has issued a safety alert for lab staff and health care professionals about a software defect in Sciex mass spectrometers. The defect may cause the devices to incorrectly assign results to samples analyzed. “This is of concern because health care professionals may make inaccurate clinical diagnoses or inaccurate medical treatment decisions for patients by relying on incorrect results from the devices,” an FDA recall notice says. (XXINSERT LINKXX) A potential inaccurate clinical diagnosis or treatment decision may lead patients to experience serious adverse health consequences, it says.

Mass spectrometers are used in lab settings to identify inorganic or organic compounds (e.g. lead, mercury, drugs, proteins, and peptides) in human specimens. They separate isotopes, molecules, and molecular fragments according to their mass through electric and magnetic fields. Health care professionals may use the results to aid in their clinical diagnosis or to help evaluate possible treatment decisions, FDA 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