FDAnews Device Daily Bulletin

GALIL MEDICAL RECEIVES FDA CLEARANCE FOR DEVICE TO TREAT BREAST TUMORS

Nov. 30, 2005
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Galil Medical recently announced that its CryoHit product family received FDA clearance for the treatment of breast fibroadenoma -- palpable, non-cancerous breast lumps. It is the most common benign tumor of the breast and the most common breast tumor in women less than 40 years of age, affecting millions of women worldwide.

These tumors are usually removed by surgical excision under local anesthesia. With Galil's minimally invasive cryotherapy, the procedure can be performed at a clinic or outpatient base.