Devices

VariSoft Infusion Sets Recalled

Unomedical is recalling certain VariSoft Infusion Sets due to the risk that the device’s connector may detach from the set which would disrupt insulin delivery. “If this occurs, insulin may continue to flow through the tubing that is now disconnected from the patient and the insulin pump would not recognize an infusion set problem and would not alert users,” a recall notice says. To date, there has been one reported injury associated with the defect.

The notice says that the defect was caused by damage to the connector piece during manufacturing, resulting in the connector becoming detached more easily from the insulin set than expected. “Disconnections occurring during sleep, or when otherwise not detected, may lead to hyperglycemia unless it is noticed and reconnected promptly,” it adds.

VariSoft is used with Tandem insulin pumps for subcutaneous insulin infusions, according to the recall notice. Its insertion angle (between 20-45°) is preferred by users who are thin or who have scar tissue or limiting potential insertion sites, it 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

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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