Bayer Gets FDA Expanded Clearance for CT Injection System

Bayer received 510(k) clearance from the FDA to expand the indication of its MEDRAD Stellant FLEX computed tomography injection system with Certegra Workstation for use in contrast enhanced mammography (CEM).

The injection system delivers accurate doses of iodinated intravenous contrast agent, which enhances an x-ray image and reveals hidden lesions or masses.

The system “ provides consistent enhancement of tumor tissue that may be missed with a standard mammogram,” the company said, adding that CEM is “superior to both standard mammography and breast ultrasound in detecting breast cancer,” in women with dense breast tissue.