Real Imaging Holdings Ltd.

The purpose of this image acquisition study is to compare, in a Reader Study, the RI8 system used in conjunction with a conventional mammography to mammography alone, and to determine whether the addition of supplementary RI8 result will improve ROC area under the curve. The study is prospective, multi-center, sequential, control trial with the woman serving as her own control. Women determined to have heterogeneously or extremely dense breast based on her previous mammogram and are undergoing routine screening mammography at one of the clinical sites assigned for this study will be eligible to join the study.

The study objective is to evaluate the added value of MIRA technology as an adjunct to mammography in the detection of malignant breast lesions in women with dense breast and/or at elevated risk of breast cancer.

The purpose of the study is to assess the effectiveness of MIRA in classifying women with dense breast tissue for supplemental breast MRI. To assess the effectiveness of MIRA for correctly classifying women with breast cancer and to evaluate the safety of the device.
In women above 30 years old who are undergoing MRI or are scheduled for image-guided needle biopsy due to lesions detected by other imaging modalities.