Combinations of HIFU + radiation as salvage therapy for recurrent prostate cancer

A newly published paper from a clinical research group in Nice, France, has reported very limited data on a small cohort of patients with recurrent localized prostate cancer after first-line therapy who were given salvage therapy using various combinations of radiation therapy and high-intensity focused ultrasound (HIFU). … READ MORE …

Where your $25,000 goes when you get HIFU in Mexico

An article in the Sunday edition of the San Francisco Chronicle has raised questions about how physicians are reimbursed for carrying out high-intensity focused ultrasound (HIFU) procedures on prostate cancer patients in the Caribbean and Mexico. … 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 …

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since an advisory panel to the U.S. Food and Drug Administration (FDA) decided not to recommend approval of EDAP TMS’s outdated form of Ablatherm technology for the treatment of low-risk prostate cancer, the company’s CEO seems to exhibit serious misunderstandings about how to work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

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