The U.S. Food and Drug Administration (FDA) is set to review on October 24 an application by women's imaging vendor Hologic for an expansion of the clinical indications for its Selenia Dimensions 3D digital breast tomosynthesis (DBT) mammography system.
Selenia Dimensions 3D is currently approved for breast cancer screening and diagnosis, and the screening exam can consist of either full-field digital mammography (FFDM) alone or in combination with DBT, according to the FDA. Hologic has submitted a premarket approval (PMA) supplement to cover new indications for its C-View software module.
C-View can generate synthetic 2D images from DBT data, and Hologic is asking to expand its indications to allow the combination of DBT with synthetic 2D images to be used as another exam option for breast cancer screening.
The hearing will begin at 8 a.m. at the Hilton Washington DC North/Gaithersburg hotel in Gaithersburg, MD, the agency said.
