GE Healthcare has received approval from the U.S. Food and Drug Administration (FDA) for its SenoClaire digital breast tomosynthesis (DBT) system.
SenoClaire is indicated for the acquisition of 3D DBT images for the screening and diagnosis of breast cancer, as well as the acquisition of 2D images. "SenoClaire can be used for the same clinical applications as traditional mammography for screening mammography," according to documents on the FDA's website.
GE received the CE Mark for SenoClaire in July 2013 and began shipping the product last year in Europe, the Middle East, Australia, and Latin America. The unit acquires nine low-dose exposures in a sweep around the breast, with the x-ray tube making a complete stop for each acquisition.
SenoClaire also includes GE's adaptive statistical iterative reconstruction (ASIR) dose reduction technology, which the company believes will enables the visualization of microcalcifications better than traditional filtered back-projection algorithms, according to GE.
SenoClaire is the second DBT system on the U.S. market, after Hologic's Selenia Dimensions system, which began shipping in 2011.
