The company has provided clinical study results and manufacturing information to the FDA in the PMA submission.
Siemens Healthcare has developed the Breast Tomosynthesis as an add-on option for the Mammomat Inspiration digital mammography system.
The Mammomat Inspiration acquires 25 projection views over an angular range of 50 degrees in the tomosynthesis mode to produce 3D digital breast tomosynthesis images, which are intended to be suitable for the screening and diagnosis of breast cancer.
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 Breast Tomosynthesis option has been commercially available and used clinically for diagnosis since 2009 in Europe, Asia, and South America.
In the US, 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.
Image: Siemens’ Mammomat Inspiration Prime Edition features new software that corrects scattered radiation. Photo: Courtesy of Siemens Healthcare
