Theraclion, a manufacturer of focused ultrasound equipment based in France, announced today that they have attained approval from the US Food and Drug Administration (FDA) for a feasibility study in the United States. Their device, EchoPulse, uses ultrasound-imaging to guide the treatment of breast fibroadenoma using focused ultrasound. Breast fibroadenoma are benign tumors of the breast, and it is estimated that 10% of women will experience them in their lifetime.
Theraclion will collaborate with the University of Virginia on this study, evaluating 20 patients to prove safety and efficacy of the treatment. This trial is considered first phase, and a multicenter pivotal study is planned upon the trial’s completion.