FDA Clears Redesigned Mammography System from Siemens Healthineers

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Mammomat B.brilliant, a redesigned mammography device that reportedly features improved ergonomics, workflow enhancements and key aspects targeting patient comfort.

The system’s laser positioning guide and curved breast compression paddles facilitate optimal breast positioning and improved consistency with image quality, according to Siemens Healthineers, the manufacturer of Mammomat B.brilliant. To further address the bending and twisting that can occur with patient positioning, the company said the automated ComfortMove feature with the Mammomat B.brilliant system allows tube head movement that is independent of the bucky.

Siemens Healthineers said the system also features cleared elements with respect to full-field digital mammography, titanium contrast-enhanced mammography (CEM) and breast biopsy procedures.

“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.”

Another feature, PlatinumTomo, a 3D tomosynthesis volume acquisition technology, is pending FDA review, according to Siemens Healthineers. The company added that the PlatinumTomo feature is currently available in Asia, Europe, and South America.