FDA temporarily approves importation of a second foreign-labeled iodinated contrast media

Bracco Diagnostics has been given the go ahead by the U.S. Food and Drug Administration to temporarily import Iomeron (iomeprol injection) into the U.S. market amid the ongoing iodinated contrast media shortage. 

Iomeron is an intravascular iodinated contrast media that can be used in adults for various imaging procedures. It is manufactured by BIPSO GmbH in Germany and Patheon Italia S.p.A. in Italy, but is not FDA approved for use in the U.S. However, it is manufactured alongside Bracco’s FDA-approved contrast, Isovue (iopamidol injection). 

In a Dear Healthcare Professional Letter shared by Bracco, the company indicates that they are coordinating with the FDA to increase the availability of the product immediately, but it will be a temporary measure only. 

This is the second imported product that the FDA has approved for use in the U.S. amid contrast supply shortages. Bayer has also been granted permission to temporarily import foreign-labeled Ultravist (iopromide), which is manufactured in Berlin, Germany. 

Some experts in the field are cautioning that the shortage could linger into late September, and that practices will need to continue to follow preservation strategies in the meantime. GE’s most recent update indicates that their manufacturing facilities in Shanghai have been operating at 100% capacity again for weeks, but that they anticipate “some ongoing reduced availability of iodinated contrast media as we continue to restabilize global supply.”   

 For more information on Iomeron, click here

Hannah murhphy headshot

In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She joined Innovate Healthcare in 2021 and has since put her unique expertise to use in her editorial role with Health Imaging.

Around the web

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.

The newly cleared offering, AutoChamber, was designed with opportunistic screening in mind. It can evaluate many different kinds of CT images, including those originally gathered to screen patients for lung cancer. 

AI-enabled coronary plaque assessments deliver significant value, according to late-breaking data presented at TCT. These AI platforms have gained considerable momentum in recent months, receiving expanded Medicare coverage in addition to a new Category I CPT code.

Trimed Popup
Trimed Popup