Fink Densford | July 10, 2018
IsoRay (NYSE:ISR) said today it won FDA 510(k) clearance for its GammaTile brachytherapy technology designed for treating recurrent brain tumors.
The Richland, Wash.-based company’s GammaTile is a radiation system using Cesium-131 radiation seeds embedded in a collagen ’tile’ which is designed to be placed in surgical margins at the time of surgery.
IsoRay said it had previously inked a collaborative development and ten-year supply agreement for the newly cleared GammaTile with GT Medical Technology, which the company said will be available in the US “in the near future.”