FDA Clears MAMMOMAT B.brilliant Mammography System From Siemens Healthineers

Siemens Healthineers announces the US FDA 510(k) clearance of the MAMMOMAT B.brilliant—the company’s 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 that remains under US FDA review.

“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.