FDA Issues Expanded Pediatric Approval of MRI Contrast Agent for Lung Ventilation Assessment
Previously approved for MRI lung ventilation evaluation in adults and children 12 and older, the hyperpolarized contrast agent Xenoview can now be utilized for pediatric patients six years and older.
The Food and Drug Administration (FDA) has granted an expanded pediatric indication for the use of the magnetic resonance imaging (MRI) contrast agent Xenoview (xenon Xe 129 hyperpolarized), which can now be used for the assessment of lung ventilation in children who are least six years of age.
Polarean Imaging, the manufacturer of Xenoview, said the expanded pediatric approval will enable the use of the agent for MRI lung ventilation evaluation in approximately one million more children.
Here one can see use of the hyperpolarized contrast agent Xenoview for MRI assessment of lung ventilation. The FDA has granted an expanded approval of the agent for use in children six years or age and older. (Image courtesy of Polarean Imaging.)
Pediatric pulmonologist Erik Hysinger, M.D., M.S., said the expanded pediatric indication for Xenoview is a significant advance for assessing and evaluating treatments for cystic fibrosis, asthma, and other chronic lung diseases in children.
“For years, I’ve studied Xenon MRI in children ages 6 to 12, and expanding access to younger patients offers clinicians a powerful tool to characterize disease progression, monitor response to therapy, and guide interventions like airway dilation or tissue removal. This imaging platform enhances our ability to deliver more personalized, precise care for children with complex respiratory conditions,” maintained Dr. Hysinger, a faculty member in the Division of Pulmonary Medicine at Cincinnati Children’s Hospital Medical Center in Ohio.
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