Siemens Healthineers has gained premarket approval (PMA) from the US Food and Drug Administration (FDA) for 3D technology in its Mammomat B.brilliant mammography system.
The PMA covers PlatinumTomo, a new 3D imaging technology that helps reduce the blur often present in 3D imaging to assist radiologists in making more confident diagnoses. The company said it builds on the 50-degree wide angle technology found in other Siemens 3D mammography systems to enable 50-degree image acquisition in less than five seconds.
The capability is made possible by the system’s fast detector and a newly approved X-ray tube, which uses flying focal spot technology adapted for breast imaging from Siemens Healthineers computed tomography (CT) scanners.
The wide-angle imaging separates overlapping layers of breast tissue – a common challenge in 2D imaging – to help visualise lesions that would otherwise be obscured. According to Siemens, the technology achieves this by providing up to 3.5 times the depth resolution (or tissue separation) of other mammography systems.
The PMA also covers Mamomar B.brilliant’s addition of Siemens’ UltraHD image reconstruction technology that reduces metal artifacts and improves the visualisation of calcifications in mammograph images.
The system’s expanded approval for 3D breast imaging follows the receipt of FDA 510(k) clearance for 2D breast imaging, titanium contrast-enhanced mammography capabilities, and breast biopsy in April 2024.
Siemens Healthineers North America vice president of X-ray products Nira Patel commented: “The FDA PMA of the Mammomat B.brilliant mammography system represents a milestone in our ongoing commitment to women’s health.
“This revolutionary system not only provides healthcare institutions with significantly improved diagnostic capabilities but also addresses the critical need for patient and technologist comfort in breast cancer screening.”
According to GlobalData, the global mammography equipment market was valued at around $2.1bn in 2023 and is forecast to reach a valuation of around $3.8bn by 2033.
In a move anticipated to strengthen its position in the medical imaging sector, Siemens Healthineers recently acquired Novartis’s diagnostics arm.
