Devices

FDA Clears Xavant Tech’s Waveform Neuromodulator

FDA has cleared a Xavant Technology 510(k) for the Stimpod NMS460, a hybrid-pulsed radio frequency waveform neuromodulation device for relieving and managing chronic intractable pain, as well as an adjunctive treatment in managing post-surgical pain, post-traumatic acute pain problems, and an adjunct for pain control due to rehabilitation. The device applies its waveform to affected areas transcutaneously, according to the company. “This waveform creates electromagnetic effects similar to invasive pulsed radio frequency treatments, and several case studies have shown instant and dramatic relief of chronic intractable pain,” it says. “The Stimpod NMS460 also incorporates the nerve-locating technology which features a nerve mapping probe that enables practitioners to locate nerves and evaluate the treatment progress of damaged nerves.”

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