The FDA’s perspective on the approval of HIFU in the USA

For those able to access the February 2016 issue of the AUA News, it carries an interesting article outlining the U.S. Food and Drug Administration’s perspective on exactly why the agency decided to approve two forms of high-intensity focused ultrasound (HIFU) technology for the transrectal ablation of prostate tissue. … READ MORE …

US FDA accepts data filing for Ablatherm HIFU technology

According to a media release issued by EDAP TMS SA yesterday, the U.S. Food & Drug Administration (FDA) has issued a positive Filing Review Notification to the company with respect to EDAP TMS’s Pre-Market Approval (PMA) application for its Ablatherm Integrated Imaging HIFU (High Intensity Focused Ultrasound) device. … READ MORE …