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Gynesonics Gets FDA’s 510(k) Clearance for Fibroid-Treating Sonata System

September 21, 2021

Gynesonics has received the FDA’s 510(k) clearance for its Sonata System 2.2 for radiofrequency ablation of symptomatic uterine fibroids.

The updated system features software advances that allow the surgeon to control all aspects of the ablation from the handpiece without requiring operating room staff to separately adjust settings.

The Sonata system, which does not require general anesthesia, is a “breakthrough alternative” to hysterectomy and surgical removal of fibroids, the company said.

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