Ultravist now approved for contrast-enhanced mammography in EU

The product can be used to evaluate and detect lesions of the breast as an adjunct to mammography (with or without ultrasound) or as an alternative when a magnetic resonance imaging (MRI) is contraindicated or unavailable.

Following the approval of the European Workshare Procedure (a decentralized mutual recognition process on EU level), the first national approvals in the EU are expected in the first quarter of 2023. CEM is an emerging modality that combines digital mammography with the administration of a contrast agent, such as Ultravist, to support the diagnosis of breast cancer and guide treatment decisions.

The approval expands Bayer’s radiology portfolio, which includes contrast media, injectors as well as digital and artific ial intelligence (AI) enabled solutions, supporting radiologists across a broad range of diseases including breast cancer.

“The approval of Ultravist-300 and -370 in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough,” said Dr. Konstanze Diefenbach, Head of Radiology Research and Development, 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 direction from diagnosis to care for patients.”