Hologic's tomosynthesis: New data presented at Radiological Society of North America conference in Chicago on Dec. 2 shows Hologics' tomosynthesis breast mammography system Selenia Dimensions has a lower recall rate than traditional mammography and can detect tumors in dense breasts. The Selenia Dimensions takes a series of images to show tissue structure in three dimensions, allowing physicians to see an anomaly in breast tissue from multiple angles. Hologic originally expected FDA to approve the PMA for Selenia Dimensions in the second quarter of 2008, but FDA approval for the device was pushed back by a July 30 letter from the agency, requesting additional information (1"The Gray Sheet" Jan. 21, 2008, p. 7). FDA will likely convene an advisory panel meeting to review the PMA. Selenia Dimensions received a CE mark in Europe during the firm's fourth fiscal quarter of 2008. "We continue to see approval as when, not if," Morgan Stanley analyst David Lewis writes in a Dec. 4 report on tomosynthesis. "Focus will eventually turn to the technology, which has garnered considerable physician interest as a revolution versus digital, although concerns on adoption, workflow and applicable market exist.
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