Bracco Imaging U.S. subsidiary Bracco Diagnostics said today that it won FDA approval for its Lumason microsphere contrast agent to be used in ultrasonography of the urinary tract in pediatric patients with suspected or known vesicoureteral reflux.
“The approval of Lumason for voiding ultrasonography answers an unmet medical need for an effective imaging study to detect and follow-up VUR without exposing neonates, infants and young children to the potential harmful effects of ionizing radiation,” head of global medical and regulatory affairs Dr. Alberto Spinazzi said in prepared remarks. “This approval reflects the efforts of Bracco to seek and provide new and expanded indications for this class of products working collaboratively with the FDA.”
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