EDAP Submits 510(k) Application for FDA Clearance of Focal One HIFU

EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the clearance of its next generation HIFU device: the Focal One^®. This submission follows the November 2015 FDA clearance of Ablatherm^® Robotic HIFU for the ablation of prostate tissue.

According toMarc Oczachowski, Chief Executive Officer of EDAP TMS SA:

We are pleased to submit our Focal One HIFU device file to the FDA to further our goal of making EDAP’s full range of HIFU products available to both urologists and patients in the U.S. There is a clear, growing demand from the worldwide urology community for non-invasive options for the ablation of prostatic tissue, and we are well positioned to address this market with our complementary Ablatherm and Focal One devices. We believe that HIFU has the potential to become a standard of care tool for prostate ablation. We are extremely excited by the progress of the U.S. commercial launch of Ablatherm Robotic HIFU and look forward to working with the FDA on the clearance process for Focal One.

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