GE Healthcare has submitted first module of premarket approval application (PMA) for its GE Breast Tomosynthesis to the US Food and Drug Administration (FDA).
The first modular application includes device description and non-clinical information including detector performance evaluation and phantom testing.
The GE Breast Tomosynthesis is an add-on option for the Senographe Essential.
When equipped with Senographe, it will acquire multiple projection views and produce 3D Digital Breast Tomosynthesis (DBT) images which aid in screening and diagnosis of breast cancer.
The company intends to file the remaining three modules of its DBT PMA with the FDA over the coming year.