The U.S. Food and Drug Administration (FDA) has approved SonaCare Medical’s Sonablate 450 focused ultrasound system for ablation therapy on prostate tissue. A pioneer in high intensity focused ultrasound (HIFU) technologies, the Indianapolis, Indiana based SonaCare reports that it has received de novo clearance from the FDA to market the Sonablate 450 in the U.S., making it the first high intensity therapeutic ultrasound (HITU) device to receive the agency’s regulatory authorization for prostate tissue ablation — a non-invasive, radiation-free technique used to treat localized prostate cancer. SonaCare Medical expects to begin U.S. distribution this month.