GE Healthcare has submitted to the U.S. Food and Drug Administration (FDA) the first module of its premarket approval (PMA) application for a digital breast tomosynthesis system. There will be a total of four modules.
GE's digital breast tomosynthesis system has been designed as an add-on option for its Senographe Essential full-field digital mammography unit; the technology will acquire multiple projection views to produce 3D digital breast tomosynthesis images suitable for screening and diagnosis of breast cancer.
The company plans to file the remaining three modules of its digital breast tomosynthesis PMA over the coming year.
