Devices

Abbott Safety Notice on FreeStyle Libre Readers

FDA says Abbott has issued a safety notice for the Readers and batteries used as part of the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash glucose monitoring systems. The Readers are small handheld devices that collect real-time glucose readings directly from a sensor worn on the back of a person’s upper arm, allowing them to manage their diabetes by seeing their glucose readings on a screen.

According to the safety notice, if the Readers are not properly stored, charged, or used with the Abbott-provided yellow USB cable and power adapter, a potential exists for battery swelling and “extreme overheating, which may pose a fire hazard.” They use lithium-ion batteries, similar to mobile phones and many other handheld electronic devices, which have the potential for battery swelling, leakage or overheating, it says.

Abbott says that no Readers are being physically recalled and customers can continue to use them with the Abbott-provided USB cable and power adapter. It offers guidance on how to safely use the Readers at www.FreeStyleBattery.com.

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