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Siemens Healthineers gets FDA nod for first completely redesigned mammo platform in over a decade

by John R. Fischer, Senior Reporter | April 08, 2024
Women's Health
Siemens Healthineers' MAMMOMAT B.brilliant mammography platform
With FDA clearance now secured, Siemens Healthineers is looking to distribute the first completely redesigned mammography system in over a decade, the MAMMOMAT B.brilliant platform, for use in U.S. hospitals, clinics, and other healthcare settings.

The solution is equipped with full-field digital mammography, breast biopsy, and titanium contrast-enhanced mammography as well as new features for boosting user ergonomics and workflow and reducing patient discomfort:

A display monitor that clearly shows the technologist patient information and work steps regardless of where the technologist is positioned

Automated ComfortMove ergonomic features for moving the tube independently of the bucky, decreasing strain on the technologist and making it easier and safer for patient access during positioning without bending and twisting

A laser positioning guide to accurately position a patient’s breasts

The ComfortPackage for better hand grip

An optimized, stationary face shield so patients can lean into the system during image acquisition for greater stability and easier positioning
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A redesigned ambient light display, personalized soft breast compression, and curved breast compression paddles to improve breast positioning for more consistent image quality and to reduce patient discomfort

“With the 510(k) clearance of the MAMMOMAT B.brilliant, Siemens Healthineers proudly introduces completely new mammography technology to the market. We believe more women deserve access to next-generation screening technology, and this innovation underlies our commitment to women’s health,” said Niral Patel, vice president of X-ray products at Siemens Healthineers North America, in a statement.

The company has also filed a premarket approval application for PlatinumTomo, the technology’s three-dimensional portion, which is now available in Europe, Asia, and South America.

PlatinumTomo acquires the tomosynthesis volume at the same angular range of 50°, the widest angle on the market, and also the same as Siemens Healthineers’ current system, the MAMMOMAT Revelation, for a high level of depth resolution and tissue separation. Its new acquisition technology comes with a new detector and X-ray tube design based on the premium z-sharp (flying focal spot) technology found on the company’s CT scanners. The flying focal spot technology enables continuous tube motion and stabilizes the focal spot size. Additionally, it has UltraHD reconstruction technology for customizable image impressions and a new form of synthetic 2D and 3D imaging.

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