The US Food and Drug Administration (FDA) has cleared IsoRay’s GliaSite radiation therapy system, a balloon catheter device used in the treatment of brain cancer.
The FDA clearance means that IsoRay will be able to seek additional regulatory approval for its new liquid form of cesium-131 internal radiation therapy for the treatment of brain cancer, which would be delivered using the GliaSite system, replacing the liquid iodine radiation Iotrex.
”We have already seen the importance of Cesium-131 internal radiation therapy seeds in effecting survivability and quality of life in the treatment of cancers throughout the body,” said IsoRay CEO Dwight Babcock.