The FDA moves slowly and I personally do not expect approval until a year or so.
Go to www.clinical trials.gov and look up ablatherm. Tests aRE underway at Duke, Baylor etc.--and when the USA catches up with the rest of the world this WILL be approved. It is currently being used in Europe, China, Canada etc. Pull up HIFU under www.Google.com.
Look at the hole page for EDAP.
As a prostate cancer survivor I had surgery. However, some can not have surgery because of health reasons and HIFU is an alternative.
Prostate problems are not "fun" but a fact of life which an aging population will have to face.
Best wishes! IAM A FIRM BELIEVER IN EDAP FOR THE LONG TERM> Day traders will not like this stock.