Bracco Diagnostics, Inc 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. 

On July 18 Fresenius Kabi announced that they are rolling out a line of generic contrast media products, starting immediately with Iodixanol Injection USP. 

Per Bayer’s communications, the contrast agent is manufactured at the same site in Berlin, Germany as the Ultravist that is intended for U.S. markets, but due to its intended distribution abroad it lacks current FDA-approved labeling. 

“CMS couldn’t have picked a worse time to cut Medicare payments to physicians,” said RBMA Executive Director Bob Still.

The new AI addition is said to increase resolution by up to 65% and is compatible with 97% of current MRI protocols.

The 40 evidence-based recommendations touch on everything from patient selection to study choice, radiation safety, clinical team dynamics, procedural techniques, study interpretations and more. 

In the June 29 announcement, the ACR revealed CMS said the additional evidence provided to them was “insufficient” to support the reconsideration of their non-coverage decision.

"Clinical study protocols may involve more than one PET [amyloid-beta] scan per patient,” the CMS announcement said.