Gynesonics announced that it received FDA 510(k) clearance for its next-generation Sonata System 2.1 for transcervical fibroid ablation (TFA).
Redwood City, Calif.-based Gynesonics’ Sonata platform integrates what the company touts as the first and only intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device. The system provides an incision-free, uterus-preserving transcervical treatment for symptomatic uterine fibroids.
According to a news release, the next-generation version of the system incorporates additional features to improve usability and streamline workflow. New features include a new treatment device design and a smaller, more ergonomic radio-frequency ablation handpiece with improved controls.
Dr. Ladina Christoffel of Spital Oberengadin — Schweiz (Samedan, Switzerland), who has performed procedures using Sonata 2.1 since last month, said in the release that improvements to the controls in the new version offer increased confidence and improved efficiency.
“FDA clearance for our advanced Sonata System 2.1 is a noteworthy achievement,” Gynesonics president & CEO Christopher Owens said in the release. “The feedback from European physicians on the improved system design and performance during the early 2020 launch in Europe is positive. This contributed to a significant increase in procedure volumes.
“We look forward to introducing the technology to the U.S. market and others around the globe. This highlights Gynesonics’ commitment to consistently deliver breakthrough advances for women’s health, while continuing to demonstrate our clinical significance through published peer-reviewed evidence.”
In January 2019, Gynesonics announced that it raised $75 million in an equity financing round to support the Sonata 2, which it then launched in November.