GE Healthcare, a unit of General Electric Company GE, announced that it
recently submitted to the U.S. Food and Drug Administration (FDA) the final
module of its premarket approval application (PMA^1) for GE Breast
Tomosynthesis, an option of the Senographe* Essential system.
In this final PMA^1 module, GE Healthcare has provided the FDA with clinical
study results and manufacturing information. The GE Breast Tomosynthesis
option has been designed as an add-on option for the Senographe Essential that
will acquire multiple projection views to produce 3D Digital Breast
Tomosynthesis (DBT) images, intended to be suitable for screening and
diagnosis of breast cancer. GE has a large Senographe Essential and Care
installed base in clinical use in the USA.
Over 1700, Senographe Essentials are in clinical use in the United States
today.
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