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.