The FDA’s approval of Bracco Diagnostics’ E-Z-HD marks the first time a barium-based contrast agent has been approved for use in the U.S., according to a company press release.
Indicated for use in double-contrast radiographic examinations to visualize the gastrointestinal tract, E-Z-HD’s approval is a breakthrough for this class of agents, said Alberto Spinazzi, MD, senior vice president of global medical and regulatory affairs for the Bracco Group.
"Barium sulfate contrast agents are critically important and routinely used in medical imaging centers nationwide to help diagnose gastrointestinal tract diseases," Spinazzi said in the release. "We are proud to be the first company working collaboratively with the FDA to pave a new regulatory path for this class of products.”
The newly approved E-Z-HD is the first in a line of new barium-based contrast agents the company is developing, according to the release.
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