The U.S. Food and Drug Administration (FDA) has issued a response to medical isotope developer IsoRay's pending 510(k) application for its GammaTile radiation therapy system.
To secure FDA clearance for the GammaTile system, IsoRay and its co-applicant, GammaTile LLC, need to submit additional data within the next 180 days, IsoRay said. GammaTile uses cesium-131 radiation seeds embedded in a collagen tile and placed in surgical margins at the time of surgery.
As a result of the FDA's response, the companies will resubmit to the U.S. Centers for Medicare and Medicaid Services (CMS) the new technology add-on payment (NTAP) application in the fall of this year, as the NTAP requires an FDA-cleared product. They have already received ICD-10-PCS coding for GammaTile, IsoRay said.
