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HIFU Regulatory Status

 

HIFU is approved in most countries

Focal One® has received regulatory clearance and is marketed in the United States, Europe, Canada, Brazil and other countries. In the United States, Focal One® is indicated for the ablation of prostate tissue.

Ablatherm® HIFU has received regulatory clearance and is marketed in the United States, Europe, Canada, Australia, Korea, Brazil and other countries. In the United States, Ablatherm® HIFU is indicated for the ablation of prostate tissue.

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