[jonwachob91]

We know that it does need FDA approval and trials. What we are hoping is that we can file what is known as a 510(k). A 510(k) is a process where we tell the FDA "Hey look at these guys, we are doing pretty much the same thing" and we can skip most of the hard and expensive part. We don't know yet if we can file a 510(k) or if we need to go through the whole process.