The Mammomat B.brilliant mammography platform by Siemens Healthineers has received 510(k) clearance by the U.S. Food and Drug Administration (FDA). Image courtesy of Siemens Healthineers,
Siemens Healthineers' Mammomat B.brilliant mammography system has received 510(k) clearance by the U.S. Food and Drug Administration (FDA).
Mammomat B.brilliant is the first completely redesigned mammography platform in over a decade, the company said. The clearance includes elements that involve full-field digital mammography, 2D breast imaging, breast biopsy, and titanium contrast-enhanced mammography.
Additionally, Siemens recently filed a premarket approval application for the 3D portion of the Mammomat B.brilliant, which includes new tomosynthesis acquisition and reconstruction technology.
New features include a display monitor that allows technologists to clearly see patient information and work steps, regardless of position, an automated ComfortMove ergonomic feature that aims to reduce physical strain on the technologist, and a laser positioning guide that helps the technologist accurately position the patient’s breast.
Siemens' ComfortPackage is included in the device, and it features an ergonomic hand grip and an optimized stationary face shield that allows patients 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.
The 3D or tomosynthesis portion of the platform that is currently under FDA review, dubbed PlatinumTomo, is already commercially available in Europe, Asia, and South America. PlatinumTomo will feature a new detector and x-ray tube design based on z-sharp (flying focal spot) technology found on the company’s CT scanners.
