Devices

Panel Summary on Amalgam, Other Metal Devices

FDA has posted a summary of the deliberations during an 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee meeting, which recommended (see earlier story) that FDA should require dentists to move away from using mercury-containing amalgams and towards non-mercury containing products like composite materials when conducting dental restoration procedures. The panel agreed that FDA’s latest literature review on dental amalgam provided more evidence on amalgam’s risks to the environment, patients and potentially to the dental professionals involved in the insertion and extraction of these materials.

The panel meeting also discussed immunological responses to metal-containing devices. FDA and other presenters provided a summary of the state of currently known science in metal implant related biological responses. Panel members discussed “device related factors that may increase or decrease an individual’s risk of an adverse response to a metal implant,” the summary says. “Factors include extent of wear, alloy composition, microstructure, and surface coating of an implant. Panelists all agreed it is important and beneficial for patient safety to have the device packaging labels updated to include a list of the elemental composition of the device.”

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