Germany-based Siemens Healthcare has submitted its premarket approval application (PMA) to the US Food and Drug Administration (FDA) for its Mammomat Inspiration digital mammography system with breast tomosynthesis option.
The PMA submission to the FDA includes clinical study results and manufacturing information of the system.
Siemens Healthcare has developed the Breast Tomosynthesis as an add-on option for the Mammomat Inspiration digital mammography system.
The system acquires 25 projection views over an angular range of 50° in the tomosynthesis mode in order to produce 3D digital breast tomosynthesis (DBT) images, which are intended to be suitable for the screening and diagnosis of breast cancer.
DBT acquires breast images from several angles to reduce the impact of overlapping breast tissue during imaging, while conventional 2D mammography produces a single, flattened breast image.
The acquired multiple-angle breast images will be combined to produce a 3D rendering of the entire breast.
Siemens Healthcare women's health and X-ray products vice-president Laurie Fisher said: "This PMA submission of Siemens Breast Tomosynthesis demonstrates our long-standing and ongoing commitment to innovation in women's health."
The company said that the Breast Tomosynthesis option has been commercially available and used clinically for diagnosis since 2009 in Europe, Asia and South America.
FDA classifies breast tomosynthesis as Class III in the US, meaning that data from a clinical trial is necessary to measure safety and effectiveness.
According to the company, Class III devices require a PMA submission to the FDA for approval.
Image: Siemens' Mammomat Inspiration Prime Edition lowers patient dose up to 30% without compromising image quality. Photo: courtesy of Siemens AG.