Clearance includes elements involving full-field digital mammography, or two-dimensional breast imaging, breast biopsy and titanium contrast-enhanced mammography. New features of the system enhance user ergonomics and workflow while reducing patient discomfort.
Siemens Healthineers also submitted an FDA premarket approval for a 3D function of the MammoMat B.brilliant. That feature includes new tomosynthesis acquisition and reconstruction technology.
“With the 510(k) clearance of the MammoMat B.brilliant, Siemens Healthineers proudly introduces completely new mammography technology to the market,” said Niral Patel, VP 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.”
Other new features include a prominent display monitor to clearly show patient information and work steps. It also has an automated ComfortMove ergonomic feature that reduces physical strain on the technologist. The company included a laser positioning guide to help accurately position the patient’s breast as well. It says these features all significantly improve workflow.
Additionally, Siemens Healthineers said it designed its system for patient comfrot. It has an ergonomic hand grip and an optimized, stationary face shield. These features combine with a redesigned ambient light display, personalized soft breast compression and curved breast compression paddles.
The addition of a 3D portion would feature completely new acquisition technology. That includes a new detector and X-ray tube.
