This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis
Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures; Women aged ≥18 years at the time of enrollment;* Women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense; At moderately increased or high risk (>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1:
AND Referred for screening mammography
Exclusion Criteria:
Have been screened using any breast imaging technology in <12 months immediately prior to enrollment; Exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment; Diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment; Are currently pregnant as determined per standard clinical practice at the investigational site; Present with contraindications to any imaging examination required in the study protocol; Have breast implants; OR Are lactating.
