Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer

The standard CBE will be performed by a nurse practitioner (NP) who will record any positive CBE finding.

The iBE is an FDA 510(k) cleared portable device which utilizes an array of dynamic capacitive pressure sensors to perform electronic palpation for breast abnormalities. The iBE exam will be administered by a mammogram technologist, blinded to CBE results.

All patients will have routine standard mammographic views performed. Patients with positive iBE and/or CBE findings will have additional mammographic and/or ultrasound imaging to determine if a correlating breast lesion is present using the same standard of care algorithm as is used currently for positive CBE findings.