FDA grants PMA for BD FocalPoint GS Imaging System

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BD Diagnostics, a segment of BD (Becton, Dickinson and Company) has received FDA premarket approval for its FocalPoint guided screening (GS) imaging system.

The new system is designed to enhance cervical cancer screening for cytology laboratories using the BD SurePath Pap test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions, according to the Franklin Lakes, N.J.-based company.

The new BD FocalPoint GS Imaging System seeks to address the limitations of Pap testing—one-third of Pap smear false negatives can be attributed to screening and interpretive errors in which abnormal cells are incorrectly classified—through its GS technology which helps relocate the fields of view that the system has identified as the most likely to contain cells of interest, BD said.