Advisory committee votes against approval of SonoCare HIFU

According to a report posted yesterday on the Medscape web site, a Food and Drug Administration (FDA) advisory committee “voted October 1 not to recommend approval, at least for now” of a SonoCare Medical’s Sonablate high-intensity focused ultrasound (HIFU) device to treat patients with radio-recurrent … READ MORE …

FDA schedules meetings to review PMAs for Ablatherm’s, SonoCare’s HIFU devices

According to a media release issued earlier today by EDAP TMS, the U.S. Food and Drug Administration (FDA) has scheduled a meeting on July 30, 2014, to review the Pre-Market Approval (PMA) application for EDAP’s Ablatherm-HIFU device for the treatment of localized prostate cancer. … READ MORE …