FDA is really pushing to get approval quick...read this news from EDAP from May end -
EDAP TMS SA provided additional details on key events scheduled as part of the U.S. Food and Drug Administration Pre-Market Approval, or PMA, process for its Ablatherm-HIFU device for the treatment of localized prostate cancer. In addition to the previously announced panel of experts that is scheduled to review the Ablatherm-HIFU device and provide a recommendation based on the clinical data submitted to the FDA, the company has additional milestones to achieve as part of the PMA application process. The first relates to an engineering, manufacturing and quality assessment of EDAP's factory, which consists of a routine inspection by the FDA. This has now been confirmed and scheduled to take place June 23-June 26. In parallel there is a clinical data validation process, which includes an FDA audit of the investigation sites. The company has received confirmation and scheduling of the "foreign" site's audit which will be conducted in the course of July. CEO Marc Oczachowski said, "Having dates confirmed for these additional milestones is further great news for EDAP, as it demonstrates how quickly the FDA process is moving for our Ablatherm-HIFU PMA application. We are very enthusiastic to see the progression of events since our last complete submission in March of this year and consider this to be a very exciting time in the Company's history."