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News & Media

Mar 20, 2014
EDAP Completes FDA Q&A Session

EDAP-TMS
EDAP Completes FDA Q&A Session for Its Ablatherm-HIFU Pre-Market Approval Application

EDAP TMS, announced today that it has completed its response to questions from the FDA regarding the Company's Ablatherm-HIFU Pre-Market Approval ("PMA") application, closing this step within the U.S. Food and Drug Administration ("FDA") review process.

This is another significant milestone within the FDA approval process for our Ablatherm-HIFU device. As per the standard FDA review timeframe, the next step is an advisory committee meeting that we expect to be held within the next four to six months. We do not believe there will be any further questions related to the filing or additional requests from the FDA prior to the panel meeting. With this step behind us, we are focusing our efforts to be fully prepared for the upcoming panel meeting.