Devices

Magnetic Stimulation for Adolescent Depression Cleared

FDA has cleared a Neuronetics 510(k) for its NeuroStar Advanced Therapy for use as an adjunct for treating major depressive disorder in adolescent patients aged 15-21 years. The company says NeuroStar is the first transcranial magnetic stimulation treatment FDA-cleared for this age group, making it the fourth FDA-cleared indication for NeuroStar. The device is described as being like physical therapy for the brain. “It uses magnetic pulses, similar in strength to MRI, to reignite dormant connections in the brain and give you control of your depression,” Neuronetics says.

“FDA’s decision to grant clearance for this new indication is based in part on analyzing real-world data collected through NeuroStar's proprietary TrakStar platform,” it says, adding that it provided “crucial insights” into the treatment’s effectiveness and safety profile in adolescents. Among the 1,169 adolescents in the data analysis, 78% achieved clinically meaningful improvement in their depression severity, 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