Siemens Healthineers has received a new go-ahead from the FDA for what the company describes as its first completely redesigned mammography platform in over a decade.
The agency’s premarket approval covers the three-dimensional imaging portion of the Mammomat B.brilliant breast scanner, dubbed PlatinumTomo. That builds upon previous green lights for 2D imaging, breast biopsy and contrast-enhanced mammography.
By adapting flying focal spot technology from the company’s CT scanners—to help counter the blurring that can happen as the sensor moves to build a 3D image—and incorporating a new X-ray tube, the system aims to acquire wider pictures of the breast in less than five seconds.
Siemens Healthineers said its ability to capture 50-degree images can help avoid how overlapping tissue may hide potential lesions in a typical 2D scan, regardless of the density of the breast.
In addition, the scanner’s UltraHD image reconstruction technology brings customizable settings, and can provide clinicians with a synthetic 2D image without additional radiation exposure.
“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,” Niral Patel, VP of X-ray products at Siemens Healthineers North America, said in a statement.
The system was unveiled one year ago at the September 2023 annual congress of the European Society of Breast Imaging, held in Valencia, Spain. At the time the company said the Mammomat’s acquisition speed clocked in at about 35% faster compared to other systems.