Drugs

Avation Medical Bladder Control Device Cleared

FDA has cleared an Avation Medical 510(k) for Vivally, which the company describes as a non-invasive, bladder control therapy device and mobile application for treating patients with urinary urgency and urge urinary incontinence caused by overactive bladder syndrome. The “closed loop” neuromodulation system “objectively confirms activation of the tibial nerve and continuously adjusts therapy parameters to ensure optimal output throughout the session,” Avation Medical says.

The device works by providing an electrical signal to the patient’s tibial nerve through an ankle-worn garment, the company says. “A clinician creates a personalized therapy range for each patient and prescribes the Vivally System for use in the home. The Vivally Controller uses a proprietary closed-loop control algorithm and electromyography (EMG) to offer personalized therapy for each patient.”

Avation Medical says Vivally’s safety and effectiveness were evaluated in a prospective, multi-center clinical study involving 96 subjects with overactive bladder (the FREEOAB Study). At six months, 69% of patients were responders for urinary urgency and 63% for urge incontinence; a responder is a subject showing at least 50% symptom improvement or a return to normal, it says, adding that there were no significant device-related adverse events during the study.

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

Read more

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