The overall objective of the evaluation was to evaluate the clinical performance of tomosynthesis biopsy using the Hologic Selenia Dimensions and the Hologic Affirm breast biopsy guidance system, and to evaluate the associated technical issues.
The detailed objectives were to:
- evaluate the usefulness of the Affirm tomosynthesis biopsy system as part of the assessment process
- assess the practical aspects of use and report on the operators’ views and experience
- assess the performance and reliability of the equipment when in use for tomosynthesis biopsies
- report on radiation dose to the breast from imaging during tomosynthesis biopsy