Treatment for prostate cancer with the Sonablate^® 500 (Sonablate HIFU) is commercially available in over 30 countries. The Sonablate^® 500 (Sonablate) is only approved for investigational use within the U.S. and is being studied for the treatment of prostate cancer in clinical trials in the U.S. The FDA has made no decision as to the safety or efficacy of the Sonablate for the treatment of prostate cancer. If the Sonablate is approved by the FDA for use in the U.S., there is no assurance that instructions for use or the specifications of the device will be the same as the device and treatment approved or authorized in other countries outside of the U.S.

The information provided on this website is for general information purposes only and is not intended to replace sound professional medical advice and care. All treatment options and potential outcomes and complications should be discussed with a qualified healthcare provider.