MAMMOMAT B.brilliant Mammography System Cleared by FDA

by Siemens Healthineers on May 17, 2024


  • First completely redesigned mammography platform in over a decade
  • New features reduce patient discomfort and improve user ergonomics
  • Premarket approval application filed for PlatinumTomo 3D portion with new technology

Siemens Healthineers has announced the Food and Drug Administration 510(k) clearance of the MAMMOMAT B.brilliant — the first completely redesigned mammography platform in more than 10 years. The clearance includes elements involving full-field digital mammography, or two-dimensional breast imaging; breast biopsy; and titanium contrast-enhanced mammography. The system’s new features enhance user ergonomics and workflow, as well as reduce patient discomfort. Additionally, the company recently filed a Premarket Approval application for the three-dimensional portion of the MAMMOMAT B.brilliant, which includes new tomosynthesis acquisition and reconstruction technology.¹

“With the 510(k) clearance of the MAMMOMAT B.brilliant, Siemens Healthineers proudly introduces completely new mammography technology to the market,” said Niral Patel, vice president of X-ray Products at Siemens Healthineers North America. “We believe more women deserve access to next-generation screening technology, and this innovation underlies our commitment to women’s health.”

Several new features benefit the radiologic technologist. They include a prominent display monitor that enables the technologist to clearly see patient information and work steps, regardless of where the technologist is positioned. The automated ComfortMove ergonomic feature reduces physical strain on the technologist, who can move the tube head independently of the bucky for safe, easy patient access during positioning without bending or twisting. A laser positioning guide helps the technologist accurately position the patient’s breast. Together, these user features can significantly improve workflow.

Other new features are designed for patient comfort. The ComfortPackage, which is standard on the system, includes an ergonomic hand grip and an optimized, stationary face shield that allows the patient to lean into the system during image acquisition for greater stability and ease of positioning. These new features are combined with a redesigned ambient light display, personalized soft breast compression, and curved breast compression paddles. These features can not only reduce patient discomfort but also improve breast positioning and enable more consistent image quality.

The 3D or tomosynthesis portion of the MAMMOMAT B.brilliant that is currently under FDA review is already commercially available in Europe, Asia, and South America. Dubbed PlatinumTomo, the new 3D technology will acquire the tomosynthesis volume at the same angular range of 50°—the widest angle on the market—as the company’s current system, the MAMMOMAT Revelation, for a high level of depth resolution and tissue separation. The 3D portion will feature completely new acquisition technology, with a new detector and a new X-ray tube design based on the premium z-sharp (flying focal spot) technology found on the company’s computed tomography scanners. The flying focal spot technology is designed to allow for continuous tube motion, while holding the focal spot size effectively stable. UltraHD reconstruction technology will provide customizable image impression as well as a new form of synthetic 2D and 3D imaging.

1 The planned 3D tomosynthesis option for the MAMMOMAT B.brilliant is currently under FDA review. Actual results may differ materially from anticipated results and may be subject to change.

For more information on the MAMMOMAT B.brilliant, click here.

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Siemens Healthineers pioneers breakthroughs in healthcare. For everyone. Everywhere. Sustainably. The company is a global provider of healthcare equipment, solutions and services, with activities in more than 180 countries and direct representation in more than 70. The group comprises Siemens Healthineers AG, listed as SHL in Frankfurt, Germany, and its subsidiaries. As a leading medical technology company, Siemens Healthineers is committed to improving access to healthcare for underserved communities worldwide and is striving to overcome the most threatening diseases. The company is principally active in the areas of imaging, diagnostics, cancer care and minimally invasive therapies, augmented by digital technology and artificial intelligence. In fiscal 2023, which ended on September 30, 2023, Siemens Healthineers had approximately 71,000 employees worldwide and generated revenue of around €21.7 billion. Further information is available at

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Siemens Healthineers AG (listed in Frankfurt, Germany: SHL) pioneers breakthroughs in healthcare. For everyone. Everywhere. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers and its regional companies are continuously developing their product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology.

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