Devices

Brain Therapy for Alzheimer’s Breakthrough Status

FDA has granted Functional Neuromodulation a breakthrough device designation for the Vercise Deep Brain Stimulation (DBS) System, developed and manufactured by Boston Scientific, for treating patients 65 years and older with mild probable Alzheimer’s disease. Functional Neuromodulation says a pivotal trial is underway to evaluate the safety and efficacy of DBS of the fornix (DBS-f) for patients with mild Alzheimer’s disease, and it will enroll up to 210 patients in the U.S., Canada and Germany. “For Alzheimer’s, DBS-f delivers stimulation to a critical location in the brain’s memory circuit that seems to enhance activity in the circuit and drive neuronal activity in other brain regions impacted by the disease,” it says. “Under the designation, the Vercise DBS Systems are indicated for unilateral or bilateral stimulation of the post-commissural fornix in the treatment of patients 65 years and older with mild probable Alzheimer’s disease as an adjunctive therapy for patients who are not adequately controlled with medications.”

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