Contrast developer Bayer has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the use of its CT injectors for contrast-enhanced mammography applications.
The FDA nod applies to Bayer's Medrad Stellant Flex CT injectors used with the company's Certegra workstation software for contrast-enhanced mammography. Contrast mammography enables better visualization of breast abnormalities that might not normally be visualized on standard mammograms.
Bayer believes that using a contrast injection system like Stellant Flex provides benefits over manually administering contrast, such as accurate dose administration. The company notes that contrast-enhanced mammography has been shown to be more accurate than either standard mammography or breast ultrasound.
