Study to Demonstrate the Preliminary Safety and Effectiveness of IPBS in Performing MRI-Guided Targeting and Intervention of Breast Tissue in Female Patients Indicated for MRI-Guided Breast Biopsy

A Prospective, Open-Label, Single-Arm, Single-Site, Study to Demonstrate the Preliminary Safety and Effectiveness of IPBS in Performing MRI-Guided Targeting and Intervention of Breast Tissue in Female Patients Indicated for MRI-Guided Breast Biopsy.

A preliminary demonstration of the Safety of IPBS in positioning a vacuum assisted biopsy (VAB) tool to enable an MRI-guided automated breast biopsy. This will consist of 10-15 biopsy procedures facilitated by the MRI-guided system. Patients will be followed after the procedure to assess clinical outcomes.

Inclusion Criteria:

• Female patients over the age of 18 with suspected or confirmed breast cancer requiring a manual MRI-guided breast biopsy for diagnosis and staging.
• Individuals Capable of giving a free and informed consent.

Exclusion Criteria:

• Any patient for whom the manual MRI-guided breast biopsy procedure would not be possible (size of patient, etc.).
• Patients who refuse the procedure for any reason will be excluded from the study at the investigators discretion.
• Patients who are not suitable for the procedure will be excluded at the investigators discretion.
• Patients unwilling to complete associated study questionnaires or follow up visits.
• Women who are pregnant or who plan to become pregnant within the study duration.