Gynesonics lands FDA clearance for fibroid-removal system

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 versi…

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