Siemens Healthineers' Mammomat B.brilliant Receives FDA Approval for 3D Mammography
Key Insights
Siemens Healthineers (search)' Mammomat B.brilliant (search) has received FDA premarket approval for its tomosynthesis, enhancing breast imaging capabilities.
The system features PlatinumTomo technology, enabling rapid 3D image acquisition and reducing blur for more confident diagnoses.
The device includes features to improve workflow for technologists and enhance patient comfort during breast cancer (search) screening.
Siemens Healthineers (search) has announced FDA premarket approval for the tomosynthesis (3D breast imaging) technology in its Mammomat B.brilliant (search) system. This approval includes new 3D image acquisition and reconstruction technology, complementing existing features for 2D imaging, breast biopsy, and contrast-enhanced mammography. The system aims to improve diagnostic capabilities, patient comfort, and workflow efficiency.
Enhanced 3D Imaging Technology
The Mammomat B.brilliant (search) utilizes a 50-degree wide-angle technology to minimize the challenge of overlapping breast tissue, which can obscure lesions in 2D imaging. This technology provides up to 3.5 times the depth resolution of some other mammography systems. The system's PlatinumTomo technology enables a 50-degree acquisition in under five seconds, reducing blur and potentially improving diagnostic confidence. This is facilitated by a fast detector and an X-ray tube using flying focal spot technology adapted from Siemens Healthineers (search)' CT scanners.
Image Quality and Artifact Reduction
New UltraHD image reconstruction technology reduces metal artifacts and enhances the visualization of calcifications, with customizable image settings. The system also generates a synthetic 2D image without additional radiation exposure, potentially reducing the need for full-field digital mammography images.
Workflow and Ergonomic Improvements
Several features are designed to benefit radiologic technologists. A prominent display monitor provides clear access to patient information and work steps. The ComfortMove feature allows independent movement of the tube head and image receptor for easier patient access. A laser guide aids in accurate breast positioning, collectively improving workflow.
Patient Comfort
The system includes an ergonomic hand grip, optimized face shield, redesigned ambient light display, personalized breast compression, and rounded compression paddles. These features aim to improve patient comfort, breast positioning, and image quality.