Bracco Diagnostics, the U.S. subsidiary of Bracco Imaging, has had its Varibar Pudding product approved by the U.S. Food and Drug Administration.
Varibar Pudding is used to evaluate oral and pharyngeal function and morphology in adult and pediatric patients prior to modified barium swallow (MBS) examinations.
"Before the approval of Varibar Pudding, no barium products were approved for use in MBS exams, nor validated prescribing information aiming at guaranteeing optimal and reproducible use and imaging results," Dr. Alberto Spinazzi, senior vice president of Global Medical and Regulatory Affairs for Bracco Group, said in a statement.
Spinazzi noted that the Varibar product line delivers convenience to clinicians; it helps them remove uncertainty in their pre-testing processes when treating patients.
“Varibar Pudding's standard 40 percent w/v ratio of barium sulfate concentration helps ensure uniform density, eliminating the potential for variability in results,” Spinazzi said. “This is our third FDA-approved barium-based contrast agent, which further serves as a testament to Bracco's commitment to the diagnostic imaging community and the patients they serve."
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