GE Healthcare Issues Final Module of Premarket Approval App for GE Breast Tomosynthesis Option
GE Healthcare, a unit of General Electric Company (NYSE: 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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