The breast tomosynthesis mode captures a range of angled pictures of tissue to produce a 3D image of the breast tissue, combining that with 2D images to provide a more robust view that can help clinicians better detect and diagnose breast cancer.
Siemens’ tomosynthesis system has been on the market in Europe, Asia and South America since 2009, but the technology is classified in the U.S. as a high-risk device, requiring more robust clinical testing before winning regulatory approval, the company said.
"This PMA submission of Siemens Breast Tomosynthesis demonstrates our long-standing and ongoing commitment to innovation in women’s health," women’s health and X-ray products vice president Laurie Fisher said in prepared remarks.
Rival mammography systems maker Hologic (NSDQ:HOLX) already has a tomosynthesis system approved in the U.S. and the company is pursing expanded approval from the FDA. Hologic’s Selenia Dimensions 3D digital mammography system originally won FDA approval in February 2011 after winning a unanimous panel recommendation in September 2010.
However, Hologic has faced hurdles in reimbursement for tomosynthesis and analysts have warned that mammography faces market hurdles that have slowed down usage.