Siemens Healthineers announced today that it received FDA 510(k) clearance for its MammoMat B.brilliant mammography platform.
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.