"The system is designed to increase accuracy when screening women for the presence of cancerous tissue, and to enable a more precise characterization of suspicious lesions," says Jay A. Stein, cofounder and chief technical officer of Hologic. "I speak for all of Hologic in voicing great satisfaction that the FDA panel has weighed in so positively in favor of this valuable new tool in the battle to limit breast cancer mortality."

Selenia Dimensions is currently approved in countries in Europe, Latin America, and Asia, and is used in Canada and Mexico. The device is available in the United States as a 2-D system but would be upgraded to 3-D imaging if or when FDA approved.