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 l
Subscribe or to access all post and page content.

Leave a Comment

Your email address will not be published. Required fields are marked *