FX.co ★ EDAP TMS Says FDA Grants Breakthrough Designation To Focal One For Rectal Endometriosis

EDAP TMS SA, popularly known as EDAP, surprised people with an announcement on Monday. In the announcement, EDAP revealed that its innovative platform, Focal One, has received the Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). The device is principally intended for treating deep infiltrating endometriosis (DIE).

Focal One HIFU is a cutting-edge, non-invasive, and robotic ablative procedure. It employs a powerful ultrasound probe, which results in tissue devitalization. This is achieved by using acoustic cavitation and thermal ablation methods.

Previously, in June 2018, the FDA had approved the Focal One Robotic Focal HIFU for the ablation of prostatic tissue. It’s an impressive leap in medical technology and paves the way for significant advancements in the field.