Bayer earns FDA clearance for contrast-enhanced mammography injection system
The Food and Drug and Administration has authorized the expanded use of Bayer’s latest injection system to begin delivering agents used in contrast-enhanced mammography, the manufacturer announced Thursday, Dec. 19.
Company officials noted that the MEDRAD Stellant FLEX can now assist radiologists in delivering iodine intravenously, making it easier to spot breast abnormalities once unseen through traditional mammography.
"This FDA clearance underscores Bayer’s continued commitment to women's health, and we are pleased to now support contrast-enhanced mammography as another alternative screening option for women," Dennis Durmis, head of Bayer Radiology’s Americas region, said in an announcement.
The Stellant FLEX’s power injection system helps radiologists to more accurately administer the right contrast dosage when compared to manual methods, Bayer noted. Such iodine enhancement is particularly useful when imaging dense breast tissue with hard-to-find tumors. Before this month’s clearance, the injection system was used primarily to deliver contrast materials and saline in CT imaging.
Upward of 46% of women older than 40 in the U.S. have dense breasts, which may require further screening beyond traditional mammography, Bayer noted.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.