Devices

BioElectronics 510(k) for Musculoskeletal Pain Patch

BioElectronics has filed a 510(k) that seeks expanded clearance for its ActiPatch Musculoskeletal Pain Therapy, a drug free, over-the-counter device seeking an indication for “adjunctive treatment of musculoskeletal complaints pain.” The device is already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis. The submission includes data from a cervical osteoarthritis (neck pain) study that compared the effectiveness of ActiPatch treatment to that of a standard of care treatment (prescription Cox-2 inhibitor etoricoxib 60mg), according to the company. “Data from the study indicates that both treatments significantly reduced neck pain, but that ActiPatch was superior to NSAID [etoricoxib] treatment (statistically significant),” 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