Therapeutic ultrasound specialist EDAP TMS SA (Nasdaq:EDAP) announced on Monday that it has obtained Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Focal One platform for the treatment of deep infiltrating endometriosis (DIE).
This designation acknowledges the significant medical need in women's health and the potential of Focal One HIFU to provide a less invasive and less morbid treatment option.
The FDA's Breakthrough Device programme expedites development, assessment and review of products for life-threatening or irreversibly debilitating conditions, facilitating timely access to medical devices.
Focal One HIFU uses high-intensity ultrasound to ablate tissue, offering a non-invasive approach to address painful symptoms associated with rectal endometriosis.
EDAP recently completed enrolment in a Phase 3 study evaluating Focal One HIFU therapy, with results expected in the second half of 2024.
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