Devices

FDA Reiterates Deep Brain Stimulator Risk

FDA says it is reminding patients and healthcare providers about the risk associated with using deep brain stimulation devices for Parkinson’s disease. “Patients may be at risk of injury during water-related activities (such as swimming) because of the loss of coordination while using the device,” an agency notice says. “Patients should also be cautious while bathing.”

The notice says the agency is aware of multiple reports of patients implanted with deep brain stimulation for Parkinson’s experiencing difficulty swimming, including near and actual drownings. FDA medical device adverse event reports and reports in the medical literature indicate that 16 patients implanted with DBC for Parkinson’s experienced difficulty swimming and/or a near-drowning event. “We are also aware of six deaths reported in association with swimming activities, two patient deaths from drowning while in a bathtub, and two patient deaths from drowning where the water activity was not specified.

The notice contains recommendations for patients and caregivers, and for healthcare providers.

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