Devices

Some Magellan Lead Tests May be Inaccurate: FDA

FDA and the Centers for Disease Control (CDC) say that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the U.S. An agency news release says the CDC recommends that parents of children younger than age 6 and currently pregnant women and nursing mothers who have been tested for lead exposure should consult a healthcare professional about possible retesting.

The release quotes CDRH director Jeffrey Shuren as saying that FDA is “deeply concerned by this situation and is warning laboratories and healthcare professionals that they should not use any Magellan Diagnostics’ lead tests with blood drawn from a vein.”

The warning is based on currently available data indicating Magellan tests, when performed on blood drawn from a vein, may provide results that are lower than the actual level of lead in the blood. The agency says the issue may date back to 2014. Shuren says FDA is “aggressively investigating this complicated issue to determine the cause of the inaccurate results and working with the CDC and other public health partners to address the problem as quickly as possible.”

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