Drugs

FDA OKs 1st Interoperable Insulin Pump

FDA is permitting marketing of Tandem Diabetes Care’s t:Slim X2 insulin pump with interoperable technology for delivering insulin under the skin for children and adults with diabetes. An agency announcement says this new type of pump, an alternate controller enabled (ACE) infusion pump, is the first interoperable pump, meaning it can be used with different components that make up diabetes therapy systems, allowing patients to tailor their diabetes management to their individual device preferences.

The agency says that insulin pumps to date have been cleared by FDA as standalone devices or approved as part of a single, predefined diabetes management system. Because the t:Slim X2 is interoperable with other diabetes device components, it was reviewed through the de novo premarket review pathway, it says.

With the marketing authorization, FDA also is establishing special controls to outline requirements for assuring the accuracy, reliability, cybersecurity, and clinical relevance of ACE infusion pumps, as well as describing the type of studies and data required to demonstrate acceptable pump performance.

Risks associated with use of the Tandem pump are similar to those with other infusion pumps, the announcement says.

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