Devices

Advisors to Discuss Leadless Pacemakers

Members of the FDA Circulatory System Devices Advisory Panel meet 2/18 to discuss and make recommendations on clinical trial, post-approval study design, and physician training for leadless cardiac pacemaker device technology. A briefing document released in advance of the session says that specifically the committee will be asked to make recommendations on generally acceptable acute and chronic profiles of key adverse event rates as well as indications for use for this device type (given availability of other technologies with different adverse event profiles), manufacturer-required training and acceptability of observed learning curves for the new device type, and necessary elements for post-approval data collection.

The document includes a general history of pacemaker technology, available public clinical data on leadless pacemaker devices, specific considerations made for the development of the pre/post market balance paradigm for this class of devices, and current FDA thinking on the known and unknown information, along with detailed questions panel members will be asked to respond to.

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