News | Contrast Media | June 26, 2023

Contrast-enhanced mammography (CEM) is an emerging modality combining digital mammography with the administration of a contrast agent 

Contrast-enhanced mammography (CEM) is an emerging modality combining digital mammography with the administration of a contrast agent

June 26, 2023 — Bayer announced that Ultravist (iopromide)-300, -370, its iodine-based contrast agent, has been approved by the U.S. Food and Drug Administration (FDA) for contrast-enhanced mammography(CEM) – making it the only contrast agent approved for this indication. 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.1 

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.2 

“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 answers from diagnosis to care for patients.” 

The approval expands upon 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 (Magnetic Resonance Imaging) to assess the presence and extent of malignant breast disease in adult patients. In 2019, the MEDRAD Stellant FLEXComputed Tomography (CT) Injection System with Certegra Workstation was also cleared in the U.S. for use in CEM. Through the use of 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.3 


About breast cancer and contrast-enhanced mammography 

In 2020, there were 2.3 million women diagnosed with breast cancer globally, according to the World Health Organization(WHO).4 Contrast-enhanced mammography (CEM) has been demonstrated to help with visualization of lesions in breast tissue and is a relatively low-cost breast imaging examination. CEM is easy to perform in everyday clinical practice and can be used in various clinical settings, such as when routine imaging produces inconclusive findings. It can also be a helpful tool when breast MRI is unavailable or contraindicated.5 

For more information: 


1 Kimeya F. Ghaderi, Jordana Phillips, Hannah Perry, Parisa Lotfi, and Tejas S. Mehta. Contrast-enhanced Mammography: Current Applications and Future Directions. RadioGraphics 2019 39:7, 1907-1920. 

2 Susan G. Koman. Breast Density on a Mammogram. Updated April 4, 2023. Retrieved June 12, 2023 from:

3 Contrast-enhanced Mammography: How Does It Work? William F. Sensakovic, et al. RadioGraphics 2021 41:3, 829-839. 

4 World Health Organization. Breast Cancer Fact Sheet. Updated March 26, 2021. Retrieved May 26, 2023 from:

5 Maxine S. Jochelson, Marc B. I. Lobbes. Contrast-enhanced Mammography: State of the Art. Radiology 2021; 299:36–48. 

Related Content of MRI Gadolinium Concerns 

Contrast Media Supply Shortage: How and What Now? 

AJR Publishes Best Practices for Iodinated Contrast Media Shortage 

Voluntary Dismissal of Chuck Norris Gadolinium Case Involving Bracco 

VIDEO: How Serious is MRI Gadolinium Retention in the Brain and Body? An interview with Max Wintermark, M.D. 

VIDEO “Big Concerns Remain for MRI Gadolinium Contrast Safety at RSNA 2017,” An interview with Emanuel Kanal, M.D. 

Radiology Has Failed to Properly Assess or Track MRI Gadolinium Contrast Safety 

Recent Developments in Contrast Media 

FDA Committee Votes to Expand Warning Labels on Gadolinium-Based Contrast Agents 

European Medicines Agency Issues Update on Gadolinium Contrast Agents 

Related Breast Imaging Content: 

VIDEO: Research and Advancements in Breast Imaging Technology 

Single vs. Multiple Architectural Distortion on Digital Breast Tomosynthesis 

Today's Mammography Advancements  

Digital Breast Tomosynthesis Spot Compression Clarifies Ambiguous Findings  

AI DBT Impact on Mammography Post-breast Therapy  

ImageCare Centers Unveils PINK Better Mammo Service Featuring Profound AI  

Radiologist Fatigue, Experience Affect Breast Imaging Call Backs  

Fewer Breast Cancer Cases Between Screening Rounds with 3-D Mammography 

Study Finds Racial Disparities in Access to New Mammography Technology 

American College of Radiology (ACR) Launches Contrast-Enhanced Mammography Imaging Screening Trial (CMIST) in Collaboration With GE Healthcare and the Breast Cancer Research Foundation

Related Content

News | Mammography

April 12, 2024 — Bayer and Hologic, Inc. announced a first-of-its-kind collaboration to deliver a coordinated solution ...

Time April 12, 2024
News | Mammography

April 12, 2024 — GE HealthCare, a leader in breast health technology and diagnostics, will feature its latest breast ...

Time April 12, 2024
News | Radiation Dose Management

April 11, 2024 — Prelude Corporation (PreludeDx), a leader in precision diagnostics for early-stage breast cancer ...

Time April 11, 2024
Videos | Breast Imaging

Don't miss ITN's latest "One on One" video interview with AAWR Past President and American College of Radiology (ACR) ...

Time April 11, 2024
News | Mammography

April 11, 2024 — Volpara Health Technologies Ltd., a global leader in software for the early detection and prevention of ...

Time April 11, 2024
News | Society of Breast Imaging (SBI)

April 11, 2024 — iCAD, Inc., a global leader in clinically proven AI-powered cancer detection solutions, announced today ...

Time April 11, 2024
Feature | Radiation Oncology | By Melinda Taschetta-Millane

In a new 3-part video series on advancements in diagnostic radiology with Robert L. Bard, MD, PC, DABR, FASLMS ...

Time April 10, 2024
News | Ultrasound Imaging

April 9, 2024 — A new Society of Radiologists in Ultrasound (SRU) expert consensus statement to improve endometriosis ...

Time April 09, 2024
News | Artificial Intelligence

April 9, 2024 —PreciseDx, a leading innovator in oncology diagnostics leveraging Artificial Intelligence (AI) for ...

Time April 09, 2024
Subscribe Now