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SonaCare Medical to Introduce Two New HIFU Products at the European Association of Urology (EAU) Congress
Date:3/14/2013

ed for use to treat prostate cancer in more than 30 countries outside the U.S.; and Sonatherm® laparoscopic HIFU surgical ablation system which is 510(k) cleared in the U.S. The FDA has made no decision as to the safety or efficacy of Sonablate® 450 or 500. In the event Sonablate® 450 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 for treatment approved or authorized in other countries outside of the U.S.

SonaCare Medical was founded in 2004 and is headquartered in Charlotte, N.C. Additional information may be found at www.SonaCareMedical.com.


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