Devices

Trividia True Metrix Glucose Monitor Early Alert

An FDA Early Alert says the agency is aware that Trividia Health has issued an urgent medical device correction for updated use instructions for four models of its True Metrix blood glucose monitors. The alert says the company is correcting the E-5 error code in the Messages section of Owner’s Booklets/System Instructions for Use and the online labeling and help guides.

The notice says the system displays an E-5 error code for a very high blood glucose event or when there is a test strip error. The revised instructions emphasize that users must seek medical attention immediately if they receive an E-5 error code and experience symptoms of high blood glucose. “As currently written,” the notice says, “the instructions could potentially lead to a delay in treatment if the user does not seek medical attention immediately when they receive an E-5 error code and are experiencing symptoms of high glucose.”

The company says that as of 1/16, there have been 114 serious injuries and one death related to the issue.

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