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.
"The potential of 3D ABUS in a screening environment is to find these 30% additional cancers that would not have been found with what is now the standard of care," Dr. Rachel Brem, director of breast imaging at George Washington University Hospital, said in prepared remarks. "Mammography is an effective tool at finding breast cancer, but it doesn’t work equally well in everyone."
The Somo•v system already has FDA clearance for diagnostic use alongside mammography and won CE Mark approval for breast cancer screening in the European Union in September 2010.
The approval was based on clinical results from the the Somo.Insight study, U-Systems claims to be the largest-ever clinical study by an ultrasound company. It was designed to evaluate whether digital mammography used with the Somo•v system was more sensitive than routine mammography alone in detecting breast cancer in women with greater than 50% dense breast tissue.
"We are very excited the FDA Panel recommended approval of a breast cancer screening indication for the Somo•v ABUS system," president & CEO Ron Ho said in prepared remarks. "If the FDA approves the Somo•v PMA, this important adjunctive screening tool for women with dense breasts has the opportunity to become widely available in clinical practice. This is vitally important, because at least 40% of women in the United Stated have dense breast tissue."