Devices

Megadyne Recalls Pediatric Return Electrodes

Megadyne is recalling (Class 1 — market withdrawal) its Megadyne Mega Soft Pediatric Patient Return Electrodes after receiving reports about patients being burned in procedures using the devices. “The use of affected product may cause serious adverse health consequences for pediatric patients, including third-degree burns, scarring, and additional surgeries,” a recall notice says. To date, there have been four reported injuries.

The soft pad electrodes are used during electrosurgery for children who weigh between 0.8 and 50 lbs to heat or cut tissue or to stop bleeding. Because electric current is delivered to the tissue with a small pen-like attachment, the return electrode pad contacts the skin and conducts the electric current from the patient back to the electrosurgical unit or generator to reduce the risk of excessive heating, the notice 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