Bayer announces that the U.S. FDA has approved its iodine-based contrast agent Ultravist® (iopromide)-300, -370 for contrast-enhanced mammography, or CEM. The product can be used to visualize known or suspected lesions of the breast in adults, as an adjunct to mammography and/or ultrasound. CEM is an emerging modality that combines digital mammography with the administration of a contrast agent, such as Ultravist, to help identify breast lesions.

Moreover, the new FDA approved indication aligns with the recent increased focus on supplemental imaging needs for women at a higher risk for breast cancer, which may include the 40%-50% of U.S. women older than 40 with dense breasts.

“The approval of Ultravist-300 and -370 in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough,” says Konstanze Diefenbach, MD, head of radiology research and development at Bayer. “We are pleased to be able to offer additional options for breast imaging to healthcare professionals, as we aim to support them in their role of providing clear answers from diagnosis to care for patients.”

The approval expands Bayer’s focus on breast imaging, with a portfolio that also includes Gadavist® (gadobutrol) injection, a gadolinium-based contrast agent approved for use with MRI to assess the presence and extent of malignant breast disease in adult patients. In 2019, the MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation was also cleared in the U.S. for use in CEM. With iodine-based X-ray contrast agents, CEM can allow for better visualization of abnormalities in breast tissue that may not be visible with standard mammography, Bayer officials say.