Breast ultrasound screening moves one step closer to FDA approval

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somo-v Automated Breast Ultrasound System
Source: U-Systems

An FDA Advisory Panel voted unanimously April 11 to recommended approval of a new breast cancer screening indication for the somo•v Automated Breast Ultrasound System (ABUS, U-Systems).

If the FDA grants final premarket approval, somo•v would be the only breast cancer screening tool approved for use as an adjunct to mammography for women with dense breasts.

Recently completed studies show the use of Automated Breast Ultrasound (ABUS) finds about 30 percent more cancers in women who have normal mammogram, normal physical examination and dense breasts, according to Sunnyvale, Calif.-based U-Systems.