GE Healthcare has sent the final module of a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its GE Breast Tomosynthesis option.
The final PMA module included clinical study results and manufacturing information for GE Breast Tomosynthesis, an add-on option for GE's Senographe Essential system. Intended to be suitable for breast cancer screening and diagnosis, the technology acquires multiple projection views to produce 3D digital breast tomosynthesis images, according to the vendor.
The first shipments of GE Breast Tomosynthesis are already underway in Europe, the Middle East, Australia, and Latin America, GE said.
