Hologic's Selenia Dimensions digital breast tomosynthesis system (Dimensions 3-D) is the first three-dimensional mammography system to reach the U.S. market following premarket approval by the Food and Drug Administration. The low-dose x-ray device provides both 2-D and 3-D images of the breast for breast cancer screening and diagnosis.
Conventional 2-D mammography systems have limitations caused by overlapping tissue in the breast that may hide lesions or cause benign areas to appear suspicious, the company explained. Clinical trials of Dimensions 3-D showed significant gains in specificity and other benefits, including improved lesion and margin visibility and the ability to accurately localize structures in the breast, the firm noted.
The approval follows endorsement of the product's safety and efficacy data by the FDA's Radiological Devices advisory panel last September.