Important Information About The Sonablate® 500 Device for Treatment of Prostate Cancer
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.
Please contact California HIFU with further questions at (707) 546-5553.