The FDA has cleared Polarean Imaging’s xenon gas-based MRI contrast agent for evaluating pulmonary function in patients aged 12 years and up.
The Durham, N.C.-based company says the approval makes the product, called Xenoview, the first inhalable to help visualize lung ventilation absent of ionizing radiation.
The announcement quotes Jason Woods, PhD, pulmonary research director at Cincinnati Children’s Hospital Medical Center.
“My colleagues and I in the Xenon MRI research community are thrilled that this technology is now available to reach both adolescent and adult patients,” Woods says. “[W]e will [now] have the ability to evaluate regional lung ventilation, delivered with a benign safety profile, which has been a major unmet need for the patients that look to us to better understand their lung disease.”
Polarean notes more than 30 million Americans have a chronic lung disease, suggesting Xenoview will fill an unmet need for noninvasive diagnostics in disease management.
The company’s CEO, Richard Hullihen, says the FDA’s green light “represents a major step forward in modern respiratory imaging, and we are proud to have pioneered this exciting new technology for clinical use. The commercial team at Polarean is prepared to rapidly launch Xenoview for clinical application.”
Along with the contrast agent, FDA has cleared related Polarean products in the image processing and MRI coil categories.
Full announcement here.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.