In 2022, FUJIFILM Healthcare Americas Corporation received 510(k) clearance for Contrast-Enhanced Digital Mammography (CEDM), an emerging modality that combines digital mammography with the administration of intravenous contrast material. Fujifilm’s CEDM offering uses a dual-energy technique performed after the IV administration of an iodinated contrast agent to identify abnormalities on the basis of angiogenesis, as well as morphologic features and density. The physiologic information provided by CEDM is similar to that provided by breast MRI, without the added time or expense of conventional breast MRI protocols. The combination of morphologic and physiologic information provided by CEDM has been shown to provide superior sensitivity and specificity in diagnosing breast cancer when compared with digital mammography alone.
