FDA approves expanded use of 'powerful' lung imaging tool
A new approval from the U.S. Food and Drug Administration will make around 1 million more patients eligible to receive a special type of contrast that enhances the evaluation of lung ventilation.
Polarean—a medical technology company that specializes in functional MR imaging of the lungs—announced the approval of the company’s New Drug Application for expanded use of Xenoview on Monday. The hyperpolarized contrast agent is now indicated for use starting at age 6 (previously, it was 12). The approval also covers new Xenoview Dose Delivery Bag sizes redesigned to accommodate the smaller lungs of pediatric patients.
Xenoview is prepared from the Xenon Xe 129 Gas Blend. It is inhaled during MR imaging of the chest to offer providers a detailed look at patients’ lung function. While Xenon imaging is not new to the field, its utilization has risen in the wake of COVID-19, as many patients have continued to struggle with respiratory symptoms after recovering from their initial infection.
Providers are hopeful the expanded indication will increase its utilization even more and help improve the management of chronic respiratory conditions in younger patients.
“This expanded indication further enhances our technology’s clinical utility, offering clinicians an advanced tool to assess the lungs in children with chronic respiratory conditions, and strengthens its return on investment for hospitals,” Polarean CEO Christopher von Jako, PhD, said in an announcement on the FDA’s decision. “We look forward to launching a controlled US market release of the pediatric Dose Delivery Bags later this year, starting with Cincinnati Children’s.”
“This approval is an exciting step for children with chronic lung diseases, such as cystic fibrosis, asthma, bronchopulmonary dysplasia, and inflammation following bone-marrow transplant,” added Erik Hysinger, MD, a pediatric pulmonologist at Cincinnati Children’s. “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.”
Learn more about Xenoview here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.