Devices

Public Workshop on Orthopedic Device Infections

FDA has announced an 11/13 public workshop entitled “Orthopedic Device-Related Infections.” The agency says the workshop is the first of a series planned to improve public understanding of infections related to orthopedic devices and appropriate mitigation measures for protecting and promoting public health in this clinical area. It will discuss new and ongoing research, potential strategies to address associated challenges, developing innovative solutions, and catalyzing collaboration among the orthopedic community stakeholders to identify regulatory science challenges related to orthopedic device-related infections, an agency notice says. Topics for discussion include (1) Current state of the science on technologies that are linked to infections associated with orthopedic devices, (2) Critical gaps in research related to infections in joint arthroplasty and orthopedic trauma devices, including medical device technologies not currently available in the U.S., (3) Novel technologies and factors that impact innovation, (4) Potential new technologies that could impact public health in joint arthroplasty and trauma care fields, and (5) Potential opportunities for appropriate collaboration between device makers, physician community, patients, government agencies and regulators to mitigate infections.

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