Devices

BlueWind De Novo for Incontinence Device

FDA has granted BlueWind Medical a de novo marketing authorization request for the Revi System, a tibial neuromodulation therapy for treating the symptoms of urgency incontinence alone or in combination with urinary urgency. The authorization was based on results from the OASIS pivotal trial, in which the device demonstrated a “statistically significant improvement with 76.4% of subjects implanted achieving at least a 50% reduction in urge incontinence episodes at 6 months (p<.0001),” BlueWind says. “At 12 months, 82.0% (114/139) of subjects completing the study achieved at least a 50% reduction in urge incontinence episodes.”

The device is implanted near the ankle during an outpatient procedure, according to the company. “When activated, the Revi implant stimulates the posterior tibial nerve to provide relief from UUI [urge urinary incontinence],” it says. “For activation, a lightweight wireless wearable is placed around the ankle once to twice daily to provide stimulation at the patient’s convenience.”

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