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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.

“I have been privileged to successfully perform over 400 HIFU procedures over the last several years outside of the US. With this approval by the FDA now official, we at HIFU Centers of America will be able to offer our non-invasive HIFU Treatment protocol which has in my opinion, proven to be more effective and safer than any other prostate cancer treatments currently available. Our hope is that many more men who suffer from prostate disease will now have a more convenient avenue to receive HIFU Treatment” Dr Wheeler continues to say “We will welcome men from all over the United States and the world to take advantage of our years of experience”

Call or Email us today for more information about HIFU* (with an Asterisk)! Our Niche Market at HCOA is treating Aggressive Prostate Cancer with predictable excellence!