News | Contrast Media | August 02, 2022

Bracco Diagnostics Inc. has announced that the U.S. Food and Drug Administration (FDA) granted import discretion of Iomeron (iomeprol injection) into the U.S. to address the ongoing iodinated contrast media shortage. The product addresses the need for the most advanced diagnostic imaging standards and will be temporarily available in the U.S. market starting at the end of August, 2022.

Bracco Diagnostics has announced that the U.S. Food and Drug Administration (FDA) granted import discretion of Iomeron® (iomeprol injection) into the U.S. to address the ongoing iodinated contrast media shortage.

Photo credit: Getty Images


August 2, 2022 – A new update has been announced as the radiology world continues to address supply disruptions of contrast media.

Bracco Diagnostics Inc., a U.S. subsidiary of Bracco Imaging S.p.A. has announced that the U.S. Food and Drug Administration (FDA) granted import discretion of Iomeron (iomeprol injection) into the U.S. to address the ongoing iodinated contrast media shortage, according to a news release issued by the company July 27, from its headquarters in Milan, Italy.

Iomeron (iomeprol injection) is a nonionic iodinated contrast medium for intravascular use in adults in various imaging procedures. Currently registered in over 50 countries in Europe and Asia, it is not approved for use in the United States.

The product addresses the need for the most advanced diagnostic imaging standards and will be temporarily available in the U.S. market starting at the end of August, 2022. It is manufactured at two Bracco locations: BIPSO GmbH, Singen (Germany), and Patheon Italia S.p.A., Ferentino (Italy).

The company offered detailed information on the temporary importation, including Importation Discretion Documentation and a Letter to Healthcare Professionals.

“We are proud that the company has worked proactively with the FDA to address the shortage of iodinated contrast agents in the U.S. market,” said Jeff Fleming, Chief Executive Officer, Bracco Diagnostics Inc. “Throughout its 95-year history, Bracco has always put people and innovation at the core of its business, and focused ongoing attention on patient health, safety, and quality of care,” added Fleming.

The temporary importation being allowed by the FDA addresses shortages of GE Healthcare’s Omnipaque (iohexol injection) and Visipaque (iodixanol injection), and Bayer’s Ultravist (iopromide injection) which resulted from COVID-19 related supply disruptions. 

Related coverage on the contrast media shortage can be found here:

https://www.itnonline.com/content/global-contrast-media-shortage-strate…

https://www.itnonline.com/content/global-contrast-media-shortage-means-…


Related Content

News | FDA

Nov. 26, 2025 — a2z Radiology AI has received U.S. FDA clearance for a2z-Unified-Triage, a single device that flags and ...

Time December 03, 2025
arrow
News | FDA

Nov. 25, 2025 —Bracco Diagnostics Inc. has announced that the U.S. Food and Drug Administration (FDA) has expanded the ...

Time November 26, 2025
arrow
News | RSNA 2025

Nov. 13, 2025 — Nano-X Imaging Ltd., a medical imaging technology company, will showcase its Nanox.ARC X multi-source ...

Time November 25, 2025
arrow
News | Interventional Radiology

Nov. 12, 2025 — On Nov. 11, Huntsman Cancer Institute at the University of Utah (the U) opened its first specialized ...

Time November 13, 2025
arrow
Feature | Teleradiology | Kyle Hardner

Once viewed as a solution for after-hours coverage, teleradiology is rapidly expanding into a critical part of radiology ...

Time November 06, 2025
arrow
News | Radiology Imaging | UC San Diego Health

Oct. 16, 2025 — A strategic collaboration between UC San Diego Health and GE HealthCare will focus on bringing advanced ...

Time October 20, 2025
arrow
Sponsored Content | Videos | Radiology Business

Bayer Radiology’s Barbara Ruhland and Thom Kinst discuss how radiology departments can address the many different ...

Time October 09, 2025
arrow
News | Mammography

Sept. 3, 2025 — According to ARRS’ American Journal of Roentgenology (AJR), a commercial artificial intelligence (AI) ...

Time September 09, 2025
arrow
News | Lung Imaging

Aug. 26, 2025 — Optellum, a global leader in AI for lung health, recently announced the world’s first thorax CT ...

Time August 26, 2025
arrow
News | Innovative Hospitals

Aug. 14, 2025 — An interventional radiologist at NYU Langone Health recently performed a procedure to relieve a patient ...

Time August 14, 2025
arrow
Subscribe Now