Gynesonics Receives FDA Approval To Commence A Pivotal IDE Clinical Trial For The Newly-Designed Vizablate® System

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Gynesonics, Inc., a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, today announced it has received approval from the U.S. Food and Drug Administration (FDA) of an investigational device exemption (IDE) for the pivotal trial, Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA Trial), of its newly-designed VizAblate® System. The system is designed to provide women with a transcervical, incision-free, outpatient option to invasive surgical procedures such as hysterectomy for the relief of symptomatic uterine fibroids.

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