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 …

New Phase I/II trial of InSightec’s MRI-guided focal ultrasound therapy

According to a media release issued yesterday by the City of Hope medical center in Los Angeles, they have become the first center in the USA to treat a patient with focused, MRI-guided, ultrasound technology using the InSightec system. … READ MORE …

Morbidity associated with HIFU at three UK academic centers

A group of three centers in the UK has been investigating the appropriate use of high-intensity focused ultrasound (HIFU) since 2004. … READ MORE …

8-year bPFS data for 1,000+ French HIFU patients

A French clinical research group has just reported 8-year biochemical progression-free survival (bPFS) data for > 1,000 men with localized prostate cancer treated with first-line high-intensity focused ultrasound (HIFU). We assume that these data were generated using the Ablatherm HIFU technology. … 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 …

Ablatherm HIFU data on low-risk patients from the @-Registry

A new study to be presented at the upcoming annual meeting of the American Urological Association in San Diego will provide data on the first-line treatment of some 358 men with low-risk prostate cancer collected in the @-Registry, all of whom received treatment with high-intensity focused ultrasound (HIFU) using the Ablatherm® form of this technology. … READ MORE …

MRgFUS in first-line management of low-risk prostate cancer

The London Health Sciences Center and the Lawson Clinical Research Institute in London, Ontario, Canada, have reported the first use of MRI-guided ultrasound ablation for the treatment of low-risk, prostate cancer. … READ MORE …

Finally … Some real 5-year outcome data on HIFU, but were the right patients being treated?

“Medium term outcomes” data following first-line treatment with high-intensity ultrasound (HIFU) are to be presented at the upcoming annual meeting of the American Urological Association. … 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 …

HIFU outcomes in Germany after an average of 8 years of follow-up

Researchers at the University of Regensburg in Germany have just reported progression-free survival data from their 14-year experience of using high-intensity focused ultrasound (HIFU) in the treatment of localized prostate cancer. This research group was one of the first to start testing the use of HIFU in the treatment of prostate cancer. … 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 …

MRI-guided focused ultrasound in focal treatment of low-risk, localized prostate cancer

In October last year, the US Food and Drug Administration approved the ExAblate MRI-guided focused ultrasound technology for the treatment of pain associated with cancer metastasis to bones, which is obviously a potential benefit for men with late stage, metastatic prostate cancer. … READ MORE …

MRI/ultrasound fusion prostate biopsy in diagnosis of prostate cancer

A new paper in this month’s Journal of Urology has suggested that biopsy of lesions identified using a 3.0 T MRI scan and targeted for biopsy using an MRI/ultrasound image fusion technique may be able to significantly improve the probability of detection of clinically relevant prostate cancers in an office setting. … READ MORE …

FDA approves ExAblate technology to treat late stage bone pain

According to a media release issued yesterday, The U. S. Food and Drug Administration has approved a form of MRI-guided, focused ultrasound therapy for the treatment of pain associated with metastatic cancer to bone. … READ MORE …

CE-TRUS-targeted vs. systematic, TRUS-guided biopsy of the prostate to diagnose prostate cancer

Contrast-enhanced, transrectal ultrasound (CE-TRUS) technology has been found to better detect high-grade prostate cancer than conventional forms of TRUS, which may make it a more appropriate method for the diagnosis of clinically important cancers and monitoring low-risk ones with less biopsies. … READ MORE …

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