MALVERN, Pa. — Siemens Healthcare has announced that it recently submitted to the U.S. Food and Drug Administration (FDA) its premarket approval application (PMA) for the MAMMOMAT Inspiration® with Breast Tomosynthesis option.
In this 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 3D digital breast tomosynthesis (DBT) images. These images are intended to be suitable for the screening and diagnosis of breast cancer.
The Siemens Breast Tomosynthesis option has been commercially available and used clinically for diagnosis since 2009 in Europe, Asia, and South America. In the U.S., 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.
Whereas conventional 2D 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 3D rendering of the entire breast. Currently breast tomosynthesis is performed with standard 2D mammography on the same breast imaging system.
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The Siemens Healthcare Sector is one of the world’s largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source – from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs some 52,000 employees worldwide and operates around the world. In fiscal year 2013 (to September 30), the Sector posted revenue of 13.6 billion euros and profit of 2.0 billion euros. For further information, please visit: www.siemens.com/healthcare.
Press release via BusinessWire.