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News Breaks
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 7, 2014
09:22 EDTEDAPEDAP TMS announces sale of Focal One HIFU device to Mannheim University Hospital
EDAP TMS announced the first successful treatments performed at Germany's Mannheim University Hospital, or UMM, using the company's Focal One HIFU device. UMM is home to one of the largest urological Centers in Germany, with more than 4,000 patients treated annually. The Department of Urology at UMM is headed by prominent urologist Pr. M.S. Michel, also Chairman of the Academy of German Urologists. The UMM Urology Department is a large certified prostate cancer center, offering the most advanced innovative imaging and therapeutic technologies to address prostate cancer.

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