EDAP TMS announces FDA breakthrough device designation to Focal One

EDAP TMS announced 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. In June 2018, the FDA cleared Focal One Robotic Focal HIFU for the ablation of prostatic tissue. “Receiving Breakthrough Device designation from the FDA represents a major milestone and reinforces our commitment to expand the use of Focal One Robotic HIFU technology to treat other patient conditions beyond prostate disease,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “This designation reflects the FDA’s recognition that deep infiltrating endometriosis remains a significant unmet medical need in women’s health with few treatment alternatives. By expanding our proprietary robotic HIFU technology, we aim to provide women with a safe and effective treatment option that is significantly less invasive and less morbid than conventional surgical approaches.”