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U.S. Department of Health and Human Services

About FDA

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Research Project: Breast Imaging

A wide variety of new breast imaging devices and acquisition modalities is under development by academia and industry. The Center requires new and improved guidance for the evaluation of such devices and systems. In this project, we develop novel techniques for the pre-market and post-market evaluation of diagnostic performance. The project focuses on four areas: (1) tools and methods for 3D breast imaging systems, (2) image quality and dosimetric evaluation of 3D clinical systems, (3) assessment methods for multi-modality x-ray/MR imaging of the breast, and (4) advanced computational models of next generation x-ray detectors. All of these four areas include experimental investigations and computational studies using techniques such as Monte Carlo simulation of radiation transport, x-ray spectroscopy, and physical and numerical anthropomorphic breast phantoms. The project will allow us to understand product submissions related to 3D imaging for detection of breast cancer, and to contribute standard methods and tools for the assessment of new breast imaging technologies. 


Physical phantoms for the evaluation of image quality in breast imaging systems: Photograph of an anthropomorphic compressed phantom (left), example x-ray image of phantom (middle), and example patient mammogram (right).