Approval of some form of Sonacare Medical’s HIFU technology?


Readers may wish to be aware that your sitemaster has been hearing whispers and rumblings that the U.S. Food and Drug Administration is either about to or has just approved some form of Sonacare Medical’s Sonablate high-intensity focal ultrasound (HIFU) techology for treatment of something related to the prostate.

As of 8:25 pm Eastern time tonight, there is no formal and precise statement about any such approval on the web sites of either the U.S. Food & Drug Administration or Sonacare Medical. Without such a formal statement, it is impossible to guess exactly what the approval might mean. It could be limited (e.g., treatment of radiorecurrent prostate cancer) or it could be extremely broad (e.g., “ablation of prostate tissue”). It could also — theoretically — only apply to an outmoded form of the Somocare Medical technology (although that would be pretty pointless). What is true, however, is that insurance coverage of HIFU will — at least initially — be closely associated with the precise wording of the approval.

Having said that, any form of approval of HIFU is likely to lead to its use outside of the actual approved labeling here in the USA — whether insurance coverage is available or not. After all, US-based patients would no longer need to leave the country to get treatment.

One Response

  1. Sitemaster,

    If you haven’t seen this already, you may want to check out this press release from NxThera regarding FDA 510k clearance for their steam ablation process for BPH. They also have plans for treating prostate cancer down the road.

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