Sam Brusco, Associate Editor04.05.24
Siemens Healthineers has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Mammomat B.brilliant, which the company claims is the first completely redesigned mammography platform in over ten years.
The clearance includes elements involving full-field digital mammography, breast biopsy, and titanium contrast-enhanced mammography. Siemens Healthineers also submitted a premarket approval application for the 3D part of Mammomat B.brilliant, which includes new tomosynthesis acquisition and reconstruction technology.
It also touts a prominent display monitor and automated ComfortMove ergonomic feature, which reduces technologist strain by allowing the tube head to be moved independently of the bucky during positioning without bending or twisting. A laser positioning guide helps to accurately position the patient’s breast.
Other attributes were designed for patient comfort—ComfortPackage includes an ergonomic hand grip and stationary face shield that lets the patient lean into the system during image acquisition. There’s also a redesigned ambient light display, personalized soft breast compression, and curved breast compression paddles.
The 3D (tomosynthesis) part of Mammomat B.brilliant is under FDA review and commercially available in Europe, Asia, and South America. PlatinumTomo acquires the tomosynthesis volume at the same angular range of 50° 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 new X-ray tube design based on the z-sharp (flying focal spot) technology found on Siemens Healthineer’s CT scanners.
The flying focal spot tech allows continuous tube motion, while holding focal spot size effectively stable. UltraHD reconstruction technology will offer customizable image impression as well as a new form of synthetic 2D and 3D imaging.
“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.”
The clearance includes elements involving full-field digital mammography, breast biopsy, and titanium contrast-enhanced mammography. Siemens Healthineers also submitted a premarket approval application for the 3D part of Mammomat B.brilliant, which includes new tomosynthesis acquisition and reconstruction technology.
It also touts a prominent display monitor and automated ComfortMove ergonomic feature, which reduces technologist strain by allowing the tube head to be moved independently of the bucky during positioning without bending or twisting. A laser positioning guide helps to accurately position the patient’s breast.
Other attributes were designed for patient comfort—ComfortPackage includes an ergonomic hand grip and stationary face shield that lets the patient lean into the system during image acquisition. There’s also a redesigned ambient light display, personalized soft breast compression, and curved breast compression paddles.
The 3D (tomosynthesis) part of Mammomat B.brilliant is under FDA review and commercially available in Europe, Asia, and South America. PlatinumTomo acquires the tomosynthesis volume at the same angular range of 50° 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 new X-ray tube design based on the z-sharp (flying focal spot) technology found on Siemens Healthineer’s CT scanners.
The flying focal spot tech allows continuous tube motion, while holding focal spot size effectively stable. UltraHD reconstruction technology will offer customizable image impression as well as a new form of synthetic 2D and 3D imaging.
“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.”