Devices

Innovative Neurological’s Electrotherapy Stimulator Cleared

FDA has cleared an Innovative Neurological Devices 510(k) for the Cervella Cranial Electrotherapy Stimulator for treating anxiety, depression, and insomnia. The device works by delivering micro pulses of electrical current across a patient’s brain. The company says that clinical studies have demonstrated that the electrical stimulation results in reduced anxiety levels, insomnia, and depressive moods.

Cervella is described by Innovative Neurological as the first cranial electrotherapy stimulator with proprietary conductive treatment electrodes that have been seamlessly integrated into noise-canceling Bluetooth-enabled headphones. “Patients can use the audio and noise cancelling features of the headphones during treatment, which allows them to use the device during study, work, or play,” it says. Additionally, the device is managed through an app on a smart device allowing for automated treatment data recording, reminders, and analytics aimed at improving patient treatment outcomes.

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