HIFU FDA Approval

The process for HIFU FDA approval is still ongoing as of today, but clinical trials are already being approved and currently taking place in some of the states in the US. Clinical trials for HIFU began in 2008 wherein the Sonablate®500 is used to trial test those prostate cancer patients who didn’t succeed the treatment using the external beam radiation therapy.

The NYU School of Medicine Urology department chairperson Dr.Herbert Lepor said, “It is my pleasure to serve as the medical monitor for the prostate cancer clinical trial program evaluating the safety and effectiveness of the Sonablate(R) 500 HIFU device.” As he said, Dr. Lepor is also in charge for the medical monitoring of the said HIFU treatment and will further study if the HIFU FDA approval could be officially possible.

Moreover, he said that “I have personally reviewed the preliminary data and observed the Sonablate(R) 500 in action and I am impressed with this advanced technology for ablating the prostate. These rigorous clinical trials will help define the appropriate role of the Sonablate(R) 500 device in the treatment of prostate cancer.”

Initially, there are 10 clinical centers in the US that are conducting the trial. It is not sure for how long the HIFU clinical trial would take place since the aim of the process is to further know how safe and effective HIFU is to prostate cancer patients not just for its short term effect but as well as to look forward on its long term effectiveness and to meet the standards set by the FDA for further marketing approval.

As of the moment there are over 100 centers all over the world where HIFU is being used including Asian countries, Europe, Canada, Mexico, North America, and others. In few years time HIFU FDA approval could be achieved since the outcome of the trial testing is showing remarkable performance on prostate cancer patients.

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