EDAP Announces FDA Breakthrough Device Designation for Focal One® in the Treatment of Deep Infiltrating Rectal Endometriosis

Focal One HIFU has potential to address large market impacting thousands of women each year LYON, France, March 4, 2024 - EDAP TMS SA (NASDAQ:EDAP), the global leader in robotic energy-based therapies, announced today that its Focal One platform has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA) for the treatment of deep infiltrating endometriosis (DIE). In June 2018, the FDA cleared Focal One Robotic Focal HIFU for the ablation of prostatic tissue. "Receiving Bre ...