FDA Issues First Approval of Tomosynthesis System

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imageIna much-anticipated decision, the U.S. Food and Drug Administration (FDA) has granted approval to bring to market a digital breast tomosynthesis system. The system, called Selenia Dimensions (Dimensions 3-D), is offered by Hologic, Inc, of Bedford, Mass.

Dimensions 3-D is purported to address the limitations inherent in mammography systems that utilize conventional 2-D imaging, for example, possible concealment of lesions or the appearance of benign areas as suspicious when patients’ other tissue overlaps tissue in the breast.

According to the company, clinical trials using Dimensions 3-D showed measurable improvement in clinical performance over conventional mammography. Such trials also showed  significant gains in specificity — the confidence to rule out cancer without recalling the patient for further study — as well as other benefits, including improved lesion and margin visibility and the ability to accurately localize structures in the breast.

Rob Cascella, Hologic’s president and CEO, said Dimensions 3-D combines the benefits of digital mammography and leverages it with the power of fast, high-quality 3-D breast imaging. Hologic executives believe tomosynthesis “has the potential to change how screening and diagnostic mammography is performed, and will prove invaluable to the earliest possible detection of breast cancer and in the reduction of unnecessary diagnostic interventions."

According to Jay Stein, PhD, Hologic co-founder and chief technology officer, the unit allows rapid performance of tomosynthesis scans, thereby enhancing performance in everyday screening as well as for diagnostic problem-solving. Over the next several years, he noted, the company envisions Dimensions 3-D as a platform technology for other imaging modalities to aid in breast cancer detection.

The Dimensions 3-D system is available on a commercial basis in more than 40 countries, including countries in Europe, Latin America and Asia. In North America, commercial versions of the solution have already been already installed in Canada and Mexico.