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Mar 9, 2015
EDAP Announces Plans to Pursue Direct De Novo 510(k)

EDAP Announces Plans to Pursue Direct De Novo 510(k) Petition in Lieu of PMA for Its Ablatherm HIFU FDA Meeting Held to Confirm Planned Approach
EDAP TMS SA announced today that, based on a recent meeting with the U.S. Food and Drug Administration ("FDA"), the Company plans to seek clearance of Ablatherm HIFU by way of a Direct De Novo 510(k) application as opposed to the Pre-Market Approval ("PMA") application amendment EDAP had been pursuing.

The Agency indicated that while PMA approval would be required for specific claims regarding treatment of prostate cancer, a prostate tissue ablation claim could be cleared via a Direct De Novo 510(k) application. The De Novo process was introduced by FDA for instances where a device is novel and there is therefore no suitable predicate device to support a standard 510(k) submission. To qualify for the De Novo pathway, the new device must also present no more than moderate risk. Therefore, the Company plans to pursue a De Novo pathway based on the discussions with FDA.

Marc Oczachowski, Chief Executive Officer of EDAP TMS SA, commented: "We are pleased with the outcome of our most recent meeting with FDA and the ongoing, open dialogue we have maintained with the Agency throughout the regulatory process. We believe pursuing a Direct De Novo 510(k) Petition is an opportunity for more expeditious clearance of Ablatherm HIFU technology in the United States. Our team is now diligently focused on preparing the De Novo application."