Siemens Healthineers has nabbed U.S. FDA 510(k) clearance for the Mammomat B.brilliant mammography platform, which includes full-field digital mammography, breast biopsy, and titanium contrast-enhanced mammography, featuring enhancements in user ergonomics and workflow, as well as reduced patient discomfort.

“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.”

New Product Features

Several new features aim to 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 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.

3D Tomosynthesis Portion

Additionally, the company filed a Premarket Approval application for the three-dimensional portion of the Mammomat B.brilliant, which includes new tomosynthesis acquisition and reconstruction technology.

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 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.