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 …

Focal therapy of just the index or primary lesion

A newly published paper in European Urology has provided us with data from one of the earliest, well-documented series of patients undergoing focal therapy of the index lesion from what is known to have been multifocal prostate cancer. … READ MORE …

FDA approves EDAP TMS’s Ablatherm technology for HIFU therapy

As predicted, the U.S. Food and Drug Administration apparently approved the Ablatherm brand of equipment for high-intensity focused ultrasound (HIFU) on November 9 for “the ablation of prostate tissue.” … READ MORE …

Focal HIFU is “sexual function sparing” in a cohort of 118 selected patients

A new paper in European Urology has suggested that men with localized prostate cancer who are treated by focal forms of high-intensity focused ultrasound (HIFU) have “a return to baseline International Index of Erectile Function — erectile and total International Index of Erectile Function scores” by 6 months after treatment which was maintained at 1 year. … READ MORE …

CureTalk about HIFU for prostate cancer now available on line

Your sitemaster is pleased to be able to report a forthright and interesting discussion yesterday with Dr. Stephen Scionti about the current and future potential of high-intensity focused ultrasound (HIFU) in the treatment of prostate cancer. … READ MORE …

EDAP TMS submits revised application for approval of their form of HIFU technology

As predicted in yesterday’s post about the nature of the approval of SonaCare Medical’s Sonablate technology as a “generic” form of treatment for prostate tissue ablation, we are likely to see rapid approval of the Ablatherm brand of HIFU technology here in America very soon as well. … READ MORE …

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 …

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