EDAP TMS SA (EDAP) announced Monday 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).
Focal One HIFU is a non-invasive, robotic ablative procedure using a high-intensity ultrasound probe to deliver tissue devitalization through use of acoustic cavitation and thermal ablation.
In June 2018, the FDA cleared Focal One Robotic Focal HIFU for the ablation of prostatic tissue.
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