The benefit of completing the study was not worth exposing subjects to the risk during COVID. Delaying the return visits would make it difficult to analyze the changes in data overtime.

Prospective, case-control study being conducted to determine the sensitivity of the SureTouch device in detecting known masses at a pre-determined level of specificity.

This is a single-center, prospective, case-control study being conducted to determine the sensitivity of the SureTouch device in detecting known masses at a pre-determined level of specificity.

Results of the mammography will be compared to the SureTouch examination results.

Subjects will have between 1 and 3 research visits and 3 follow-up surveys, up to two years from the initial visit. The number of visits will be based upon comparison of the SureTouch examination to conventional breast screening techniques (mammogram and ultrasound).

Inclusion Criteria:

Arm 1:

• Female Subject presenting for screening mammography
• 30-80 years of age, inclusive
• Able to provide written informed consent

Arm 2:

• Female Subject presenting for diagnostic appointment and/or biopsy
• 30-80 years of age, inclusive
• 1-3 masses per breast
• Masses between 0.5 cm and 3.5 cm only

Exclusion Criteria:

• Individuals who are unable to comprehend or unwilling to sign an informed consent form
• Women younger than 30 or older than 80
• Pregnant women
• Women who have undergone bilateral mastectomies
• Males
• Prisoners
• Masses which are larger than 3.5 cm or smaller than 0.5 cm in size
• Individuals with more than 3 masses per breast will be excluded due to the complexity of these cases