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.