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It is official! FDA has approved Ablatherm HIFU Therapy for use in the United States!
November 9, 2015
EDAP Receives FDA Approval for Ablatherm HIFU EDAP TMS SA, the global leader in therapeutic ultrasound, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Ablatherm® Integrated Imaging HIFU in the U.S. for the ablation of prostate tissue. EDAP expects to commercialize Ablatherm® HIFU in the U.S. immediately.
Marc Oczachowski, EDAP Chief Executive Officer commented: “This is a tremendous achievement for the Company and the result of many years of hard work from our team. This clearance represents a unique opportunity for EDAP and its superior HIFU technology to penetrate the largest prostate market in the world in the same way it has emerged as the leading HIFU technology in Europe. With an established US sales and services infrastructure, the pieces are in place to begin deploying Ablatherm devices in the U.S. very quickly and we look forward to bringing the technology to urologists as well as patients in need.”
With this announcement, plans were immediately put into place to open HIFU Centers of America flagship Center of Excellence in Sarasota, Florida, the home of Dr Ronald Wheeler, one of the world’s most experienced and successful HIFU practitioners.