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FDA approves 2-D mammography software
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The FDA today approved the use of new imaging software for use in mammography, according to its manufacturer.
C-View 2D (Hologic) generates 2-D images from 3-D tomosynthesis data obtained during mammography screenings. This results in less time under compression, increasing patient comfort and reducing the required radiation dose, company officials said in a press release.
“Eliminating the need for additional 2-D exposures will provide a better experience for patients,” Peter Soltani, Hologic’s senior vice president and general manager of breast health, said in the release. “Large-scale clinical studies have shown that screening with Hologic’s 3-D mammography technology allows radiologists to visualize the breast in greater detail than with 2-D mammography alone, which results in earlier detection of cancers while at the same time reducing the false-positives associated with conventional 2-D mammography that cause unnecessary anxiety and cost.”
Hologic’s 2-D imaging software has been commercially available in Europe, as well as parts of Asia and Latin America, for about 2 years.
The FDA approved the company’s 3-D mammography technology in 2011.