Is HIFU available in the US?

HIFU with the Sonablate® 500 is not approved for use in the U.S. The Sonablate® 500 remains investigational in the U.S. and is being studied for the treatment of prostate cancer in clinical trials in the U.S. FDA has made no decision as to the safety or efficacy of the Sonablate® 500 for the treatment of prostate cancer.

Currently, the device is approved for the treatment of prostate cancer in Canada and the Dominican Republic, authorized in Argentina, and available in the Bahamas and Mexico.

Sonablate® is a Registered Trademark of Focus Surgery, Inc. of Indianapolis. The Sonablate® 500 is only approved for investigational use in clinical trials by the United Stated Food and Drug Administration. Focus Surgery, Inc. is the Sponsor of the clinical studies.