US FDA accepts data filing for Ablatherm HIFU technology


According to a media release issued by EDAP TMS SA yesterday, the U.S. Food & Drug Administration (FDA) has issued a positive Filing Review Notification to the company with respect to EDAP TMS’s Pre-Market Approval (PMA) application for its Ablatherm Integrated Imaging HIFU (High Intensity Focused Ultrasound) device.

What this means is that the data provided by the company is sufficient for the FDA to proceed with a full substantive review of the data provided, in which the FDA will evaluate the safety and effectiveness of the Ablatherm Integrated Imaging HIFU device for the treatment of low-risk, localized prostate cancer, as well as EDAP TMS’s engineering, manufacturing, and quality systems.

We should be clear that the issuance of positive Filing Review Notice by the FDA is not a statement that the technology will necessarily be approved for this indication. It is only a stement that the data provided by the company meets the FDA’s requirements for conduct of a full review.

As yet, we are not aware that the FDA has issued a similar Filing Review Notification to SonaCare Medical with respect to that company’s PMA for the competing Sonablate 500 technology.

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