The US Food and Drug Administration's (FDA) Radiological Devices Panel of the Medical Devices Advisory Committee has recommended approval for U-Systems' somo v Automated Breast Ultrasound (ABUS) system.
The company’s premarket approval (PMA) application is seeking a breast cancer screening indication for the somo v ABUS system, which is currently FDA-cleared for diagnostic use as an adjunct to mammography.
George Washington University Hospital breast imaging director Rachel Brem said with the positive FDA panel review of the somo v for breast cancer screening, the hospital now has the opportunity to integrate 3D automated breast ultrasound screening into clinical practice, which will enable it to find previously undetectable cancers.
"The potential of 3D ABUS in a screening environment is to find these 30 percent additional cancers that would not have been found with what is now the standard of care," Brem added.
U-Systems president and CEO Ron Ho said if the FDA approves the somo v PMA, the 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," Ho added.