Devices

FDA Clears eNeura Expanded Use for Migraine Device

FDA has cleared an eNeura 510(k) for its Spring TMS, indicated for the acute and prophylactic treatment of migraine headache. The prescription-only device uses single-pulse transcranial magnetic stimulation to induce a mild electric current that modulates nerve cells in the brain, according to the company. It says the safe, non-invasive technology is believed to interrupt the brain hyperactivity associated with migraine. “Patients place the device at the back of the head, and with the simple push of a button, deliver a focused magnetic pulse to treat a migraine attack and or to prevent the onset of future migraine attacks,” eNeura says.

Previously, the device was cleared for acute migraine treatment. The expanded indication was granted based on data from eNeura’s post-market ESPOUSE (eNeura SpringTMS Post-market Observational U.S. Study) trial, which was conducted at eight headache centers on 132 migraine patients, according to the company. “Data from the study indicated that patients following a protocol of daily use of the SpringTMS device reported an average reduction from nine headache days per month at baseline to six days post treatment,” it says. “In addition, 46% of patients reported at least a 50% reduction in headache attacks.”

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