Devices

Consider DaVinci Cautery Instrument Ban: Petition

Unplug the Robot member Jennifer Nelson, who says she has had to have multiple surgeries and other procedures in an effort to repair damage caused by a DaVinci Robotic permanent cautery instrument, is petitioning FDA to “seriously revisit and reconsider the issue of banning and recall of all permanent cautery instruments (spatula and hook) for all DaVinci Robotic surgeries.”

The petition says the request is made “because of ongoing malfunctions, injuries, and deaths recorded in the MAUDE database, patent applications by manufacturer, new lawsuits filed, and historical data in studies. As FDA’s primary focus should be to ensure patient safety first and foremost, inaction would place an ‘unacceptable’ number of patients at risk of premature death and injury as well as causing devastating harm to the families.”

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