FDA Approves Low-dose, Two-dimensional Mammography Software
Hologic, Inc, announced today that the U.S. Food and Drug Administration (FDA) has approved the use of C-View, a new low-dose two-dimensional (2D) imaging software. C-View 2D images may now be used in place of the conventional 2D exposure previously required as part of Hologic’s FDA-approved three-dimensional (3D) mammography (breast tomosynthesis) screening exam.
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 3D and C-View 2D images results in less time under compression, greater patient comfort, and a lower radiation dose, while still providing the 2D images required as part of the 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.
"Eliminating the need for additional 2D exposures will provide a better experience for patients," said Peter Soltani, Hologic Senior Vice President and General Manager, Breast Health. "Large-scale clinical studies have shown that screening with Hologic's 3D mammography technology allows radiologists to visualize the breast in greater detail than with 2D mammography alone, which results in earlier detection of cancers while at the same time reducing the false positives associated with conventional 2D mammography that cause unnecessary anxiety and cost."
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
