Siemens Announces FDA Clearance of Mammography System

The U.S. Food and Drug Administration (FDA) has cleared MAMMOMAT Revelation, a mammography platform from Siemens Healthineers with the new InSpect integrated specimen imaging tool and the new HD Breast Biopsy solution for one-click targeting of suspicious areas. These and other features are designed to expand precision medicine and improve the patient experience.
 
MAMMOMAT Revelation’s InSpect integrated specimen imaging tool permits imaging and real-time review of biopsy samples at the workstation. This tool improves biopsy workflow, shortens compression time, and reduces patient discomfort.
 
HD Breast Tomosynthesis offers the widest image acquisition angle available at 50 degrees. The wide angle delivers the industry’s highest depth resolution for better separation of overlapping breast tissue, providing high-quality 3D images for improved diagnostic confidence and earlier lesion detection. This technology is the basis for MAMMOMAT Revelation’s HD Breast Biopsy solution, which enables one-click targeting of suspicious areas with a ±1mm accuracy.
 
Nearly half of all women in the United States who receive mammograms have dense breasts, complicating efforts to identify breast lesions. Typically, the radiologist assesses breast density visually after the patient has left the facility. MAMMOMAT Revelation is the first platform to offer automated breast density measurement during the mammogram for immediate, personalized risk stratification, and more personalized care.
 
MAMMOMAT Revelation’s Personalized Soft Compression adjusts the level of breast compression automatically to suit each patient’s anatomy.  Coupled with ergonomic SoftComp Paddles, Personalized Soft Compression enables improved breast positioning, more consistent image quality, and less discomfort and anxiety.
 
And for inconclusive cases, MAMMOMAT Revelation offers titanium contrast-enhanced mammography as a cost-effective alternative to magnetic resonance imaging (MRI), reducing scheduling conflicts and reassuring the patient.
 
“MAMMOMAT Revelation is another example of Siemens Healthineers innovation that aids in early breast cancer detection,” said Martin Silverman, Vice President of X-ray Products at Siemens Healthineers North America. “Building on the industry’s widest angle in breast tomosynthesis, MAMMOMAT Revelation delivers an improved patient experience. For the first time, healthcare providers have next-generation tools that make a real difference in diagnostic certainty.”