EDAP TMS Receives FDA Device Designation for Endometriosis Platform

EDAP TMS has been granted the breakthrough device designation by the US FDA for its Focal One platform in the treatment of deep-infiltrating endometriosis.   

Focal One HIFU is a robot-assisted treatment that is non-intrusive and works by using a powerful ultrasound probe to target and destroy tissue using sound waves.  

The second-stage study showcased a notable decrease in symptoms post-treatment and reduced lesion volume, as evidenced by an MRI scan.  

The organisation is looking to continue research with a stage three trial that will analyse the device’s ability to manage pelvic pain, a symptom of deep infiltrating endometriosis.   

Ryan Rhodes, the head executive at EDAP TMS, stated, “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.”  

Rhodes went on to add, “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.” 

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