- Bayer ( OTCPK:BAYZF ) ( OTCPK:BAYRY ) said on Monday that its iodine-based contrast agent Ultravist-300, -370 was approved for contrast-enhanced mammography (CEM) in the 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 not suggested or unavailable.
- "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 Konstanze Diefenbach, head of Radiology Research and Development, Bayer.
- The German conglomerate said 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 Q1 2023.
- The company noted that the approval expands its radiology portfolio, which includes contrast media, injectors and digital and artificial intelligence (AI) enabled solutions.
- CEM is a method which combines digital mammography with the administration of a contrast agent, such as Ultravist, to help in the diagnosis of breast cancer, the company added.
For further details see:
Bayer's contrast agent Ultravist gets approval in EU for use in breast cancer detection