Devices

Valencia Tech PMA for Bladder Electrical Stimulation

Valencia Technologies has filed a PMA for its eCoin Peripheral Neurostimulator System for use in treating overactive bladder. The device is designed to provide intermittent electrical stimulation of the tibial nerve using a leadless nickel-sized implant. The PMA application that was accepted for filing by FDA was part of a modular application including three parts: non-clinical testing, manufacturing, and clinical. The final clinical module addressed all formal feedback of FDA in response to the first two modular submissions, the company says.

The submission is based on Valencia’s pivotal study, a 133-patient prospective, single-arm, multicenter trial. Study subjects, who were followed through at least 12 months, had overactive bladder syndrome with urgency urinary incontinence, and had tried at least one second or third-line therapy, the company says. Detailed results are to be reported by investigators at upcoming academic conferences and in publications, 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