HIFU has just been approved by the FDA in the past two months. First was the SONACARE machine, an American product, and 2 weeks ago the ABLATHERM device made by EDAP TMS SA, a French company, was approved. Both companies announced sales soon after approval, and I expect HIFU will become the gold standard in prostate ablation.
EDAP has applied for approval of their newest device, the FOCAL ONE, which does the ultrasonic ablation and MRI simultaneously, for a much more accurate job. I expect the FOCAL ONE will be approved in the near future, now that the HIFU technique has been approved, and it will become the best prostate cancer treatment available. The FOCAL ONE had already been approved in the EU and Canada, and success rates are around 85%, with negligible side effects.
I own lots of EDAP shares, which are still cheap, and have read many discussions of why it took so long to gain FDA approval. Consensus is that the FDA panel is overly controlled by surgeons, and prostate surgery is their bread and butter business. Further, there are, surprisingly, many urologists who are not even aware of the success of HIFU.
Yep...those are the tools used on my hub...glad to see it was finally approved. Too bad more urologists don’t promote it...follow the money. We are lucky that because of my health problems about 12 years ago we ended up with Dr. Jonathan Wright of Tahoma Clinic...who the FEDS have put thru hell for years...he recommended HIFU to my husband.