ABSTRACT
The authors review successive phases in the evaluation of a new breast imaging technology. This starts with determining whether there is any potential for the new instrument, its proper operation, and criteria for interpreting the studies. The results need to be compared with a gold standard such as pathology. The second phase evaluates the new technology in a blinded fashion. The final phase is the use of the instrument as an independent screening test compared with the gold standards of clinical examination and mammography.
