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News Breaks | | | | February 1, 2013 | | 08:35 EDT |  | EDAP | EDAP submits FDA PMA application for Ablatherm-HIFU
EDAP TMS announced the submission of its Pre-Market Approval, or PMA, application to the FDA on January 31 for the company's Ablatherm-HIFU. or High Intensity Focused Ultrasound, for treatment of low risk, localized prostate cancer. EDAP's PMA submission includes data from the ENLIGHT study, a multi-center U.S. Phase II/III clinical trial that completed the two-year follow-up needed to evaluate its primary endpoint in August 2012, as well as data from the company's extensive worldwide database of treatment information and follow-up data from patients who have undergone HIFU therapy for prostate cancer. | |
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News For EDAP From The Last 14 Days Check below for free stories on EDAP the last two weeks. |
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| May 24, 2013 | | 10:34 EDT | | EDAP | Sabby reports 5.79% passive stake in EDAP TMS
 Subscribe for More Information | | | May 20, 2013 | | 09:28 EDT | | EDAP | EDAP's Ablatherm-HIFU demonstrates long-term efficacy
Subscribe for More Information | | | May 16, 2013 | | 07:35 EDT |  | EDAP | EDAP TMS reports Q1 EPS (27c), may not compare to one estimate (5c)
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