Bayer received FDA 510(k) clearance for expanded use of its Medrad Stellant Flex CT injection system with Certegra Workstation.
The system is cleared for use in contrast-enhanced mammography (CEM), which can allow for better visualization fo abnormalities in breast tissue that may not be visible in standard mammography.
“This FDA clearance underscores Bayer’s continued commitment to women’s health, and we are pleased to now support CEM as another alternative screening option for women,” Dennis Durmis, head of Region Americas Bayer Radiology, said in a news release.
Stellant Flex features 150 ml and 200 mL syringe sizes, beacon technology to easily visualize fluids, syringe size barcode identification, lot and expiry date information, increased accuracy and automation of documentation with contrast barcode reader and a training program.
Using CEM can allow x-ray images to become more enhanced and reveal hidden lesions or masses in the breast. Bayer’s Stellant Flex enables accurate contrast dose administration and provides consistent enhancement of tumor tissue that could be missed in a standard mammogram.