Bayer gets FDA nod for contrast with mammography

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.