Hologic Inc. (HOLX) announced that the U.S. Food and Drug Administration or FDA approved the use of Hologic's new C-View 2D imaging software. The company said C-View 2D images may now be used in place of the conventional 2D exposure previously required as part of a Hologic 3D mammography (breast tomosynthesis) screening exam.
According to the company, C-View images are generated from the 3D tomosynthesis data acquired during the mammography exam, eliminating the need for additional 2D exposures. The combination of Hologic's 3D and C-View 2D images results in less time under compression, for greater patient comfort and a lower radiation dose, while still providing the 2D images required as part of Hologic's FDA approved 3D mammography screening exam. Clinical studies have shown that screening with Hologic's 3D mammography technology using C-View imaging results in clinical performance superior to that of a conventional 2D mammogram.
The company noted that C-View 2D imaging software has been commercially available in Europe and many countries in Latin America and Asia since 2011. C-View software is available as an optional package to new and existing customers. The company said it expects to begin shipments in the U.S. in June 2013.
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