Devices

J&J Wins Approval for Dual-Energy Cardiac Ablation Platform

FDA has approved Johnson & Johnson’s Dual Energy Thermocool Smarttouch SF Platform, a catheter ablation system that combines pulsed field (PF) and radiofrequency (RF) energy delivery in a single device for treating cardiac arrhythmias. The platform allows electrophysiologists to switch between pulsed field and radiofrequency ablation using the same catheter, providing greater flexibility to tailor treatment based on patient anatomy and procedural complexity, the company says. The system is integrated with the company's CARTO cardiac mapping platform, which provides imaging, navigation and guidance during ablation procedures.

Johnson & Johnson says the approval builds on its Thermocool Smarttouch SF catheter platform, which has been used to treat more than one million patients in the U.S. The addition of pulsed field ablation reflects the rapidly growing adoption of the technology, which selectively targets cardiac tissue while potentially reducing damage to surrounding structures compared with conventional thermal ablation.

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