Gynesonics submits 510(k) premarket notification for uterine fibroid treatment

Gynesonics announced that it has submitted its 510(k) Premarket Notification to the FDA for its Sonata System. The Sonata System is a uterus preserving, incision-free uterine fibroid treatment that was designed to treat fibroids transcervically with radiofrequency energy. “Submission of the 510(k) application is an important milestone for our company,” Chris Owens, president and CEO

New medicines could eliminate uterine fibroid surgeries

Decision Resources Group, a healthcare research and data company, suggests that the launch of new medicines could provide a long-term management alternative to uterine fibroids surgeries over the next 10 years. Effective medical alternatives to surgical procedures will include novel selective progesterone receptor modulators (SPRMs) including Allergan and Gedeon Richter’s ulipristal, Bayer’s vilaprisan, and Repros’s

This uterine fibroid treatment is underused despite being cost-effective

A new study suggests that a minimally invasive, image-guided treatment for uterine fibroids is used a lot less than other surgical treatments. Hysterectomies were performed 65 times more than the minimally invasive uterine fibroid embolization (UFE), which has even been proven to cost less and result in a shorter hospital stay. “These findings suggest there