U-Systems' breast cancer tool wins FDA panel nod

April 12, 2012 by MassDevice staff

The FDA's radiological devices panel recommends approval of U-Systems' somo•v ultrasound-based breast cancer screening system.

U-Systems logo

The FDA's radiological device panel voted to recommend U-Systems' Somo•v automated breast ultrasound system for pre-market approval as a breast cancer screening tool.

If approved, Somo•v would be the only ABUS system in the U.S. indicated for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue.

Dense tissue in the breasts may pose an increased risk of cancer and represents a challenge for traditional mammography, according to a press release.

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