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Lauren Dubinsky, Senior Reporter | April 20, 2020
From the April 2020 issue of HealthCare Business News magazine
“There is the potential for adverse reactions from any contrast agent, so having resuscitation equipment and trained personnel is a prerequisite for administering any contrast agent,” said Coley. “Ultrasound contrast agents are no different and [this] does not mean that they are not safe and that with an appropriate medical indication their risk/benefit profile is very favorable.”
To date, the ICUS petition is still pending. The FDA has to examine it carefully since it affects all of the ultrasound contrast agents in the U.S., but advocates remain hopeful.
“In the last few years, the FDA has consistently removed more and more restrictions as more evidence has come out,” said Darge. “They have been closely following the available current evidence and the large body of evidence that is emerging.”
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