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.
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