Devices

Class I Recall of Abbott FreeStyle Libre 3 Glucose Sensors

FDA has classified Abbott Diabetes Care’s recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring sensors as a Class I recall, the agency’s most serious designation, warning that continued use could cause serious injury or death. The recall involves specific lots of the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors that may provide falsely low glucose readings, potentially leading patients to make dangerous treatment decisions. Abbott has advised distributors, healthcare providers, and patients to immediately stop using affected sensors and remove them from sale or use.

According to an FDA recall notice, incorrect readings that underestimate actual blood glucose levels could cause people with diabetes to consume excessive carbohydrates or skip or delay insulin doses, increasing the risk of severe health complications. As of 1/7, Abbott reported 860 serious injuries and seven deaths associated with the issue.

The real-time continuous glucose monitoring devices are approved for people aged four and older and are intended to replace fingerstick blood glucose testing for treatment decisions.

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