Medical isotope developer IsoRay has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its GammaTile brachytherapy treatment.
GammaTile features proprietary cesium-131 brachytherapy seeds designed to deliver a highly targeted dose of intense radiation treatment, while limiting radiation exposure to surrounding tissue.
IsoRay's wholly owned subsidiary, IsoRay Medical, collaborated with GT Medical Technologies to develop GammaTile therapy. Their agreement includes an exclusive 10-year supply agreement for GammaTile therapy.
The U.S. Centers for Medicare and Medicaid Services (CMS) has clarified coding for GammaTile in a hospital setting with a new, specific ICD-10-PCS code, according to IsoRay.
