Radiologists have known for decades that the sensitivity of mammography for detecting breast cancer is lower in women with dense breasts. This remains true today even with the advent of digital breast tomosynthesis (or 3D mammography). The first U.S. FDA-cleared 3D whole breast ultrasound technology developed with this approach is the SoftVue whole-breast imaging system from Delphinus Medical Technologies. Currently 510(k) cleared for diagnostic imaging purposes only, SoftVue is the subject of a 10,000-patient, multi-center research project, the results of which will be used to expand the use of SoftVue for screening women with dense breast tissue in combination with mammography.
