Devices

Expanded Clearance for eNeura Migraine Device

FDA has cleared an eNeura 510(k) for its single-pulse Transcranial Magnetic Stimulation (sTMS) device and expanded use in acute and preventive treatment of migraine to include children 12 years of age and older. The company received clearance for acute and preventive treatment of migraine in adults in 2017.

sTMS is a prescription-only device that uses single-pulse transcranial magnetic stimulation to induce a mild electric current that modulates nerve cells in the brain. The technology is believed to interrupt the brain hyperactivity associated with migraine, according to eNeura. Patients place the device at the back of the head, and with a push of a button, deliver a focused magnetic pulse to treat a migraine attack and/or to prevent the onset of future migraine attacks.

Expanded clearance was supported by data from eNeura's ESPOUSE study. “Following a protocol of daily use, 46% of patients reported at least a 50% reduction in headache attacks,” the company says.There were no serious adverse events reported during the study, 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