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since an advisory panel to the U.S. Food and Drug Administration (FDA) decided not to recommend approval of EDAP TMS’s outdated form of Ablatherm technology for the treatment of low-risk prostate cancer, the company’s CEO seems to exhibit serious misunderstandings about how to work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

Outcomes after first-line and repeat HIFU procedures in the UK

In the UK, the team led by Drs Ahmed and Emberton has been meticulous in its collection and reporting of outcome data related to their investigational use of high-intensity focused ultrasound (HIFU) in the treatment of localized prostate cancer. … READ MORE …

NICE publishes guidance on focal HIFU for the treatment of localized prostate cancer in UK

In the UK, the National Institute for Clinical Excellence (NICE) has just published guidance on the use of focal forms of high-intensity focused ultrasound (HIFU) for the treatment of (low- and intermediate-risk forms of) localized prostate cancer. … READ MORE …

4-year bPFS in a series of 400+ Canadian men treated with first-line HIFU

We finally appear to have mid-term follow-up data from a sizeable series of North American patients with low- and intermediate-risk prostate cancer treated with first-line, high-intensity focused ultrasound (HIFU). The follow-up is limited to a median of 2 years, however, which allows projection of outcomes at 4 years. … READ MORE …

Korean study says that HIFU “does not provide effective oncologic outcomes”

A new paper by clinical researchers in Korea has concluded that treatment with high-intensity focused ultrasound (HIFU) “does not provide effective oncologic outcomes even in low risk patients with prostate cancer as well as in the intermediate or high risk groups,” but does have a low associated incidence of treatment complications. … READ MORE …

New data suggest that salvage HIFU after EBRT is “a high-risk procedure”

A new article reports data from two centers on experience with whole-gland high-intensity focused ultrasound (HIFU) salvage therapy for local recurrence following external beam radiation therapy (EBRT). .. READ MORE …