Approval criteria for SonaCare Medical’s HIFU technology

The U.S. Food & Drug Administration has now posted, on its web site, the approval letter issued to SonaCare Medical with reference to the approval to market the company’s Sonablate® 450 technology. … READ MORE …

FDA approves HIFU for “prostate tissue ablation”

According to a media release issued by SonaCare Medical early this morning, the company has received approval from the U.S. Food and Drug Administration (FDA) to market its Sonablate® 450 technology in the U.S.A. for prostate tissue ablation. … READ MORE …

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 …

Three generations of Sonablate HIFU equipment … the data from Japan

Over the weekend, one of our regular commentators brought to our attention a newly published, retrospective analysis of data on the risks and benefits of treatment of localized prostate cancer with three successive generations of high-intensity focused ultrasound (HIFU) equipment from the company now known as Sonocare Medical. … READ MORE …

FDA advisory committee rejects Ablatherm application

In an entirely unsurprising result yesterday, an advisory committee to the U.S. Food and Drug Administration (FDA) voted very clearly against the approval of EDAP TMS’s Ablatherm technology for treatment of low-risk, localized prostate cancer using high-intensity focused ultrasound (HIFU). … 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 …