Drugs

Medtronic Deep Brain Stimulator Lead Approved

FDA has approved a Medtronic PMA for the SenSight Directional Lead System used for deep brain stimulation (DBS) therapy. The company says the device is designed for treating some symptoms associated with movement disorders like Parkinson's disease, dystonia and essential tremor, and medically refractory epilepsy.

DBS comprises a small pacemaker-like device that sends electrical signals through leads to a targeted area in the brain related to symptoms of certain neurological disorders. Medtronic says its device can capture objective data for more efficient, informed programming. The device can also help detect “local field potentials (LFPs), which are brain signals that correlate with the severity of Parkinson’s symptoms. When physicians can detect LFPs, they can correlate these brain signals with stimulation and events capturing medication, symptoms, or side effects to deliver personalized, data-driven therapy and adjust this therapy as patient needs evolve,” 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

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