With the CE Mark approval, Gynesonics can market its next generation VizAblate system throughout the EU.

VizAblate integrates ultrasound image guidance and radiofrequency ablation into a single handheld device. The device uses radiofrequency energy to ablate fibroids under intrauterine sonography guidance.

Users can visually target specific fibroids and optimize ablations within them with the new VizAblate device and software. VizAblate’s unique transcervical access is simple, is associated with short procedure times, requires minimal in-procedure assistance, and is incision-free.

The VizAblate system features proprietary intrauterine ultrasound probe that provides high-resolution, clear image. It does not violate the uterine serosa or peritoneal cavity and is a distinct alternative to power morcellation procedures.

Gynesonics president and CEO Christopher Owens said that the company offers a unique and differentiated approach to treating symptomatic uterine fibroids that combines ease-of-use with excellent clinical results.

"We look forward to sharing additional clinical data while moving forward with our commercialization strategy to provide millions of women with a novel and less-invasive solution to treat their symptomatic uterine fibroids," Owens added.