The FDA would not approve HIFU for the treatment of prostate cancer. The HIFU manufacturers said, "if you won't approve our machines for the treatment of prostate cancer, will you at least approve it for the removal of prostate tissue?" So once the FDA approved it for that purpose, they couldn't stop urologists from using it in men who had prostate cancer. Insurance won't cover it, however. So Uros charge patients about $20,000 out-of-pocket per treatment, and it usually involves multiple treatments.
Cryo sometimes gets covered because there is a registry.
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