FDA clears redesigned mammography platform from Siemens Healthineers

Siemens Healthineers has obtained U.S. Food and Drug Administration clearance for its Mammomat B.brilliant, a complete rebuild of its mammography platform, designed to improve patient comfort. This marks the first major redesign from Siemens in over a decade. 

Patient comfort is prioritized through features like the ComfortPackage, including ergonomic hand grips, optimized face shields, ambient light displays, and personalized breast compression paddles. For technologists, enhancements such as a prominent display monitor, automated ComfortMove ergonomic feature and laser positioning guide aim to reduce physical strain.

“We believe more women deserve access to next-generation screening technology, and this innovation underlies our commitment to women’s health,” Niral Patel, vice president of X-ray Products at Siemens Healthineers North America said in a statement sent to Health Imaging.

Submitted for additional clearance is a 3D tomosynthesis technology that promises improved depth resolution and tissue separation through innovative detector and X-ray tube designs, as well as UltraHD reconstruction technology for enhanced imaging capabilities. Once cleared, it will be part of the Mammomat B.brilliant platform.

Chad Van Alstin Health Imaging Health Exec

Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.

Around the web

GE HealthCare said the price of iodine contrast increased by more than 200% between 2017 to 2023. Will new Chinese tariffs drive costs even higher?

These risks appear to be present regardless of a person's age or health at the time of infection.

Agfa and Sectra both performed well with end-user satisfaction scores in the 2025 Best in KLAS list of radiology IT systems.