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.

The full Bloomberg story is available on line, as is the full 63-page report just issued by the FDA, prior to the advisory committee meeting that is scheduled for tomorrow (Wednesday, June 30).

This type of negative agency review will need some strong push-back from the members of the FDA’s advisory committee if the Ablatherm device is to be approved for treatment of prostate cancer in the USA.

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