Devices

FDA Clears Reader for FreeStyle Libre 3

FDA has cleared an Abbott 510(k) for a reader for its FreeStyle Libre 3 integrated continuous glucose monitoring system. The reader is a small handheld device that displays real-time glucose readings obtained from a small sensor worn on the back of a person’s upper arm, allowing them to manage their diabetes, the company says. “People who use the FreeStyle Libre 3 system will still have the option to use the current FreeStyle Libre 3 smartphone apps,” it adds.

The reader uses a rechargeable lithium-ion battery. “The user manual for the FreeStyle Libre 3 reader provides details on how to safely store, charge and use the device, including always using the Abbott-provided USB cable and power adapter,” Abbott says. Earlier this month, an FDA safety notice warned (see story) that if the FreeStyle 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.”

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

Read more

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