Drugs

Tandem Diabetes Insulin Pump App Recall

Tandem Diabetes Care has issued an update on its March recall of its Apple iOS t:connect mobile app in the U.S. due to an issue that can cause rapid depletion of a user’s t:slim X2 insulin pump battery. “This battery depletion can result in the pump shutting down sooner than expected, which some customers have continued to experience following the release of version 2.7.1 of the app in March,” the update says. Notices were emailed to impacted customers on 8/9 with updated information and recommendations for helping avoid pump battery depletion. Tandem plans to release a new version of the app to address the remaining issues and will notify all users by email and app push notifications following its release.

“Under-delivery of insulin because of a pump shutdown can result in hyperglycemia or diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugar and lack of insulin,” the notice says. To date, there have been 107 confirmed adverse events 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