GE has provided the FDA with the device description and non-clinical information, including phantom testing, and detector performance evaluation
WAUKESHA, WI -- NOVEMBER 10, 2011-- 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 first module of its premarket approval application (PMA) for GE Breast Tomosynthesis, an option of the Senographe* Essential system.