FDA OKs Hologic, Inc.'s C-View 2D Imaging Software
Published: May 21, 2013
Hologic Receives FDA Approval for a New Low-dose 3D Mammography (Breast Tomosynthesis) Solution for Breast Cancer Screening
BEDFORD, Mass., May 21, 2013 /PRNewswire/ -- Hologic, Inc. (Hologic or the Company) (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women, today announced that the U.S. Food and Drug Administration (FDA) approved the use of Hologic's new C-View 2D imaging software. 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.
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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.
"Approval of our C-View software is an important evolution in Hologic's 3D mammography screening program. 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. "C-View software was developed to provide yet another option to imaging centers to improve patient care and clinical outcomes. 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."
Hologic's 3D mammography technology has been approved for use in countries recognizing the CE mark since 2008. It was approved for use in the U.S. for breast cancer screening and diagnosis in 2011. Hologic systems are now in use in 48 states in the U.S. and over 50 countries. 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. Hologic expects to begin shipments in the U.S. in June 2013.
About Hologic, Inc.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems, and surgical products, with an emphasis on serving the healthcare needs of women. The Company operates four core business units focused on diagnostics, breast health, GYN surgical and skeletal health. With a comprehensive suite of technologies and a robust research and development program, Hologic is committed to improving lives. The Company is headquartered in Massachusetts.
Hologic and C-View are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.
Forward-Looking Statement Disclaimer.
This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic digital mammography systems and C-View technology. There can be no assurance the systems will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the systems can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in the Company's expectations or any change in events, conditions or circumstances on which any such data or statements are based.
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SOURCE Hologic, Inc.
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