November 23, 2010 — The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has issued an “approvable letter” for the Selenia Dimensions system for breast tomosynthesis (3-D) imaging.
Clinical studies have shown that breast tomosynthesis technology will significantly reduce patient recall rates and improve cancer detection. The Selenia Dimensions system for breast tomosynthesis (3-D) imaging addresses many of the limitations present in stand-alone 2-D mammography and improves upon both sensitivity and specificity. Hologic is the first to receive an FDA “approvable letter” for this new technology.
Selenia Dimensions 3-D digital mammography tomosynthesis systems are installed in more than a dozen countries, including countries in Europe, Latin America and Asia. In North America, commercial systems are installed in Canada and Mexico. After a plant inspection to ensure its manufacturing facilities, methods and controls are in compliance with the applicable requirements of the Quality System regulation, Hologic can begin commercial distribution of the new system in the United States.
For more information: www.hologic.com