My best guess is that there is a big deal brewing in the US....

My best guess is that there is a big deal brewing in the US. That is why filing is being held off, and that is why the CEO is going to the US today- why would he go back so quick after he was there 2 weeks ago- he is going to seal a big deal I believe, and possibly announce it before the 510k filing. Who knows, they may even hold off on the 510k so they can ship this deal before the filing too.

GSW i think you are right with the idea that the announcement you expect is never the one you get. Judging by large buy orders in last few days, i think there is something bigger than anyone knows brewing, and i feel it is US deal- this US trip was not scheduled, it has been quickly arranged, and I believe for good reason.