HIFU Regulatory Status


HIFU is approved in most countries

Ablatherm® HIFU has received regulatory clearance and is marketed in Europe, Canada, Australia and other countries outside the United States (U.S.). Ablatherm® HIFU is seeking approval for market introduction in the U.S. following FDA requirements including completion of a Phase III Clinical Trial.

Focal One® has received CE marking and is now cleared for marketing throughout Europe and other countries except the U.S.

Phase III Ablatherm® HIFU FDA clinical trial

A phase III clinical study for Ablatherm® HIFU, sponsored by EDAP TMS has been initiated in the U. S. Patients diagnosed with low risk localized prostate cancer were recruited to participate in the study. Patient recruitment and follow-up phases of the study are now completed. The Pre-Market Approval (PMA) file is currently under review by the FDA.

HIFU can be subject to local regulations. For more information, please contact us.