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HIFU Regulatory Status


HIFU is approved in most countries

Focal One® and Ablatherm® HIFU have received regulatory clearance and are marketed in the United States, Europe, Canada, Korea, Brazil and other countries. In the United States, Focal One® and Ablatherm® HIFU are indicated for the ablation of prostate tissue.


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