BD Diagnostics received premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) for their system, BD FocalPoint GS Imaging System, to enhance screening effectiveness for squamous carcinoma and adenocarcinoma of the cervix as well as precursor conditions of the cervix in cytology laboratories utilizing the BD SurePath™ Pap test slides.
The BD FocalPoint GS System uses a guided screening (GS) technology in which the system identifies and relocates fields of view most likely to include cells of interest. The system is designed to reduce the rate of false negatives resulting from screening and interpretive errors associated with standard Pap tests.
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