Devices

Gynesonics’ Sonata Fibroid Ablation System Cleared

FDA has cleared a Gynesonics 510(k) to market its Sonata Sonography-Guided Transcervical Fibroid Ablation System. The ultrasound system with a proprietary radiofrequency ablation device “provides a transcervical, incision-free, uterus-preserving treatment for uterine fibroids,” the company says. The device exceeded “FDA-specified 12-month primary endpoint performance requirements for the Sonata System in the SONATA pivotal IDE clinical trial used to support the FDA regulatory 510(k) filing,” it says. Co-primary endpoints included a significant reduction in bleeding and a high rate of freedom from surgical reintervention due to heavy menstrual bleeding. And safety outcomes were also favorable, including zero device-related adverse events reported in the 147-patient trial.

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

Read more

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