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HIFU Regulatory Status


HIFU is approved in most countries

Ablatherm® HIFU has received regulatory clearance and is marketed in the United States, Europe, Canada, Australia, Korea, Brasil and other countries. In the United States, Ablatherm® HIFU is indicated for the ablation of prostate tissue.
Focal One® has received CE marking and is now cleared for marketing throughout Europe and other countries outside the U.S.

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