• Female patients 18 years or older diagnosed with breast fibroadenoma and presenting at least one fibroadenoma.

• Diagnosis of fibroadenoma must be based on:

∙ Clinical examination

‣ Ultrasound image alone for patients under 35 years old. For women older than 35 years, a mammogram will be performed in addition to ultrasound. The BI-RADS score of this mammogram must be 2 or 3. BI-RADS score of 4 is eligible if biopsy indicates fibroadenoma with concordance.

‣ Histologic confirmation by core needle biopsy.

• Patient is a candidate for the surgery.

• The fibroadenoma treatment volume must be at least 5 mm and no more than 26 mm from the skin. This criterion should be evaluated immediately prior treatment, once the breast is immobilized and potentially compressed.

• The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance from the posterior wall of the fibroadenoma must be at least 10 mm). This criterion shall be evaluated immediately prior to treatment, once breast is immobilized and potentially compressed.

• The fibroadenoma is 1 cm or greater at its largest dimension and no less than 7.5 mm in the anterior-posterior dimension (measured by ultrasound). Focal point for HIFU treatment must also be at least 3 mm from any border of the fibroadenoma.

• Patient's fibroadenoma size is greater or equal to 0.2 cc and less than 10 cc in volume (measured by ultrasound on the day of the procedure).

• Fibroadenoma is palpable.

• Pain ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days

⁃ Anxiety ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days

⁃ Patient has signed a written informed consent.