July 30 -- Hologic Inc. announced that the company's Selenia Dimensions three-dimensional (3-D) digital mammography tomosynthesis system has been scheduled to be reviewed by the Radiological Devices Panel (Panel) of the U.S. Food and Drug Administration (FDA) on September 24, as part of the company's pre-market approval (PMA) application. The PMA application being reviewed was originally filed in 2008 and subsequently updated with additional data, and seeks approval of the use of the system for both screening and diagnostics. In addition, Hologic is conducting a number of additional clinical trials for a separate FDA submission expected to be filed at a later date.
Selenia Dimensions is available commercially in more than a dozen countries, including Europe, the Middle East, South America, Asia and Australia. In North America, commercial Selenia Dimensions systems are installed in Canada and Mexico. In the United States, Selenia Dimensions is currently available as a two dimensional (2-D) only system that is upgradeable to do breast tomosynthesis (3-D) imaging if and when the product is approved by the FDA.
The Hologic Selenia Dimensions digital mammography tomosynthesis system is a new method for breast cancer screening and diagnosis. Unlike current mammography systems, which generate a 2-D image, breast tomosynthesis produces a 3-D image.
"Over the past several years, Hologic has been diligently working on new technologies, most notably the development of breast tomosynthesis," said Rob Cascella, president and chief executive officer. "This Panel review of our Selenia Dimensions breast tomosynthesis system is part of the FDA process of assessing this remarkable new technology. The system is specifically designed to address the primary limitation of 2-D digital mammography, namely the superposition of normal breast anatomy that may mask a breast cancer. We believe tomosynthesis represents the next phase in breast cancer detection — fast, high-quality 3-D imaging of the breast. We are thrilled to have a Panel date set for September as an important step in the review of our next-generation technology."