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Siemens/Hologic

This article was originally published in The Gray Sheet

Executive Summary

PMA application for Siemens' full-field digital mammography system, incorporating Hologic's DirectRay amorphous selenium detector component, will be filed by year-end, the firm says. Under an agreement with Hologic, Siemens has access to data for the DirectRay to support the submission. The selenium detector received an FDA "approvable" letter for PMA supplemental approval as part of Hologic's LORAD Selenia FFDM on July 11; full approval is expected this fall...
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