Devices

FDA Continues ‘Aggressive’ Investigation on Magellan Tests

FDA says it continues to “aggressively investigate” Magellan Diagnostics LeadCare and LeadCare II blood lead testing systems due to concerns they may underestimate blood lead levels and give inaccurate results when processing venous blood samples (see earlier story). In June, Magellan recalled all lots of the tests manufactured between 9/2013 and the present and distributed between 1/1/14 and 5/22/17.

“As part of the FDA’s commitment to understanding what caused the inaccurate results associated with Magellan Diagnostics' LeadCare tests, the agency conducted an inspection of Becton Dickinson (BD) & Company, the manufacturer of certain blood collection tubes used alongside these tests,” CDRH Office of In Vitro Diagnostics and Radiological Health director Alberto Gutierrez is quoted as saying in an update. “The FDA’s investigators observed several potential violations of federal law at BD’s facility; however, at this time, we have not determined that the BD tubes or any other brand of tube is linked to the cause of the inaccurate lead test results.” To view the inspection’s Form 483, click here.

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