FDA Requests More Data After Reviewing IsoRay’s Application for GammaTile Radiation Therapy

FDA Requests More Data After Reviewing IsoRay’s Application for GammaTile Radiation Therapy
IsoRay, a company specializing in the treatment of prostate and other cancers, has received a response from the U.S. Food and Drug Administration (FDA) regarding the company’s pending 510(k) application for its GammaTile radiation therapy system. Following a review, the FDA said IsoRay and its co-applicant GammaTile needed to submit additional data within the next 180 days as a condition of securing FDA clearance for the GammaTile device. A 501(k) application, or premarket notification, is required by the FDA of all medical device manufacturers of their plans to market a device at least 90 days in advance. The FDA determines whether the device is new or equivalent to one already on the market so that it can be properly classified. The GammaTile radiation therapy system uses IsoRay’s proprietary Cesium-131 radiation seeds, which are embedded in a collagen "tile" and placed in surgical margins at the time of surgery, enabling very elevated doses of radiation to be precisely delivered to targeted tissue without damaging the surrounding areas. This therapeutic approach is called brachytherapy. Through an alliance with the Barrows Neurological Institute in the United States, more than 80 patients have already been treated with GammaTile in clinical trials over the last five years. Results point to an extension of a median time to recurrence with a very low rate of side effects, the company reported in a
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