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EDAP TMS SA
EDAP,
the global leader in therapeutic ultrasound, announced today that the U.S.
Food and Drug Administration has provided a positive Filing Review
Notification on the Company's Pre-Market Approval (PMA) application for its
Ablatherm Integrated Imaging HIFU (High Intensity Focused Ultrasound) device
for the treatment of low-risk, localized prostate cancer. The FDA conducted a
filing review of EDAP's PMA, and found it to contain all of the information
needed to proceed with the substantive review, in which the FDA will evaluate
the safety and effectiveness of Ablatherm Integrated Imaging HIFU device, as
well as EDAP's engineering, manufacturing and quality systems.
Marc Oczachowski, Chief Executive Officer of EDAP TMS, commented, "Receiving
FDA filing acceptance for our PMA in less than two months is both very timely
and a major milestone. We are moving forward in the PMA Review Process as the
agency commences its substantive review. We will continue to work closely with
the FDA review team."
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