FDA Clears Gynesonics’ Sonata System for Treating Uterine Fibroids

The FDA granted 510(k) approval for Gynesonics’ Sonata system, a sonography-guided transcervical fibroid ablation device.

The device uses intrauterine ultrasound technology with a radiofrequency ablation device to treat uterine fibroids.

The Sonata system provides women with a transcervical treatment for uterine fibroids that requires no incisions.