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 …

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 …

How NOT to get your technology approved rapidly by the FDA

In a second statement to the media since an advisory panel to the U.S. Food and Drug Administration (FDA) decided not to recommend approval of EDAP TMS’s outdated form of Ablatherm technology for the treatment of low-risk prostate cancer, the company’s CEO seems to exhibit serious misunderstandings about how to work with the FDA. … 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 has questions about Ablatherm HIFU device

According to a report on the Bloomberg News web site, the FDA’s reviewers appear to be less than enthusiastic about the effectiveness and safety data submitted by EDAP TMS to support approval of the Ablatherm device for use of high-intensity focused ultrasound (HIFU) for the treatment of low-risk forms of prostate cancer. … 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 …

Ablatherm HIFU data on 5,000+ patients with T1 to T3 localized prostate cancer

Another paper to be presented at the upcoming annual meeting of the American Urological Association (AUA) offers us some additional data on the effectiveness and safety of high-intensity focused ultrasound (HIFU) carried out using the Ablatherm technology and recorded in the @-Registry database. … 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 …

EDAP TMS submits data for approval of HIFU to US FDA

We understand from media reports that the French medical device company EDAP TMS has submitted documentation to the U.S. Food & Drug Administration (FDA) for pre-market approval of their Ablatherm technology for treatment of low-risk, localized prostate cancer with high-intensity, focused ultrasound (HIFU). … READ MORE …

15 years of experience with HIFU using Ablatherm technology

A media release issued by EDAP TMS SA — the developer and distributor of the Ablatherm® technology used in high-intensity focused ultrasound (HIFU) treatment of men with prostate cancer — states that a review of 15 years experience with Ablatherm technology will be published in the June issue  of Current Urology Reports. … READ MORE …

The Tuesday news reports: March 31, 2009

In today’s news there are reports on:

  • Initial diagnosis of intraductal carcinoma of the prostate
  • An aborted trial of HIFU using the Ablatherm device
  • Late rectal complications after prostate brachytherapy … READ MORE …