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July 31, 2014
07:10 EDTEDAPEDAP TMS says FDA panel votes against Ablatherm-HIFU device
EDAP TMS announced last night that the FDA's Gastroenterology and Urology Devices Panel voted 3 yes, 5 no with 1 abstention on the question of safety, 9 no on the question of efficacy, and 8 no with 1 abstention for the risk/benefit ratio for the use of its Ablatherm-HIFU device for the treatment of low-risk, localized prostate cancer. Marc Oczachowski, EDAP's CEO, commented, "We are disappointed by the Committee's recommendation regarding Ablatherm-HIFU for the treatment of low-risk, localized prostate cancer and we appreciate the dialogue during today's meeting. We look forward to subsequent discussion with the FDA. We will continue to work diligently with the FDA as it carefully completes its final review for Ablatherm-HIFU's PMA."
News For EDAP From The Last 14 Days
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October 21, 2014
08:37 EDTEDAPEDAP announces sale of Focal One HIFU device to Nantes-Atlantis urology clinic
EDAP TMS announced the sale of a Focal One system to Nantes-Atlantis urology clinic, the top-ranked private prostate cancer clinic in France, and the country's only private clinic exclusively dedicated to urology. Nantes-Atlantis Urology clinic is led by five renowned experts in urology, and offers the latest innovative technologies to patients suffering from urological diseases. The clinic performs more than 5,000 urological procedures per year, including more than 1,000 prostate cancer treatments. Nantes-Atlantis urology clinic has been successfully using the Focal One system on a mobile, per-treatment basis since early 2014, with 110 focal treatments performed year-to-date. By using the system on a per-treatment basis, Nantes-Atlantis' clinical team was convinced of the superiority of the focal HIFU technology and its revolutionary IRM/ultrasound fusing imaging approach, which led to its decision to purchase the device.

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