U-Systems won a date with the FDA to review its pre-market application for the first ultrasound device indicated for breast cancer screening.
The somo.v Abus device, which is set to undergo agency review on April 11, 2012, is already FDA-cleared for diagnostic use as an adjunct to a mammogram.
"This is a significant milestone, not only for the company, but also for women with dense breast tissue," president & CEO Ron Ho said in prepared remarks. "The limitation of mammography in women with dense breasts is well documented. This panel review…brings us one step closer to an approved adjunctive screening tool for women with dense breasts. This is vitally important, because an estimated 40-45% of women in the United Stated have dense breast tissue."
The FDA agreed in November, 2011, to review the system and the data collected from the Somo.Insight clinical study, the largest trial ever conducted by an ultrasound company, according to a press release.
"For most women, mammography remains the gold standard for the early detection of breast cancer, but multiple studies have demonstrated that it is not enough for women with dense breast tissue," Somo.Insight principal investigator Dr. Rachel Brem said in prepared remarks."Adding automated breast ultrasound screening for women with dense breast tissue has the potential to significantly improve cancer detection rates in this population."
U-Systems won CE Mark approval in the European Union for the device in September 2010.