Siemens Healthineers has secured premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for a tomosynthesis version of its Mammomat B.brilliant mammography system.
The approval covers new 3D image acquisition and image reconstruction technology called PlatinumTomo, which allows for a 50° acquisition in less than five seconds, according to Siemens, and technology called UltraHD which reduces metal artifacts, improves visualization of calcifications, and offers customizable image settings. Mammomat B.brilliant also automatically produces a synthetic 2D image.
Already cleared features of the device include breast biopsy capability; titanium contrast-enhanced mammography; ComfortMove, an automated ergonomic feature that allows users to move the tube head independently of the image receptor; personalized breast compression; and a laser guide for breast positioning, Siemens said.
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