Siemens Files for FDA Approval of 3-D Mammography System

Siemens Healthcare has submitted a premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for its Mammomat Inspiration with breast tomosynthesis option, the company recently reported.

In its PMA submission, Siemens Healthcare has provided the FDA with clinical study results and manufacturing information. The Siemens breast tomosynthesis option has been designed as an add-on option for the Mammomat Inspiration digital mammography system. In tomosynthesis mode, the Mammomat Inspiration acquires 25 projection views over an angular range of 50 degrees to produce 3-D digital breast tomosynthesis (DBT) images. These images are intended to be suitable for the screening and diagnosis of breast cancer.

Conventional 2-D mammography produces a single, flattened breast image, DBT acquires breast images from several angles to minimize the impact of overlapping breast tissue during imaging. These multiple-angle breast images are combined to create a 3-D rendering of the entire breast. Currently breast tomosynthesis is performed with standard 2-D mammography on the same breast imaging system.

The breast tomosynthesis option has been commercially available and used clinically for diagnosis since 2009 in Europe, Asia and South America. In the United States, the FDA classifies breast tomosynthesis as Class III, meaning that data from a clinical trial is required to measure safety and effectiveness. Class III devices require a PMA submission to the FDA for approval.

“This PMA submission of Siemens breast tomosynthesis demonstrates our long-standing and ongoing commitment to innovation in women’s health,” said Laurie Fisher, vice president, women’s health and X-ray products Siemens Healthcare.

Siemens Healthcare is based in Malvern, Pa.