Devices

FDA Clears Cochlear Baha 5 Hearing System

FDA has cleared a Cochlear Ltd. 510(k) for the Cochlear Baha 5 SuperPower Sound Processor for use in children and adults with high degrees of mixed hearing loss. The device is designed to make difficult listening situations easier, according to the company, which describes it as the “first and only super power bone conduction solution with smart, direct-to-device wireless technology for patients with significant hearing loss.” The device combines the company’s bone conduction technology with its Nucleus cochlear implant. It features a behind-the-ear sound processor with a fitting range up to 65 dB SNHL. “Patients with this type and degree of hearing loss often struggle more than most to hear and understand speech, especially in noisy situations,” the company says. “Many of these patients currently use a body-worn solution to help improve their hearing experience, but still have difficulty due to insufficient features and outdated audio processing technology.”

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