Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts

Inclusion Criteria:

- 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.