Look at the stock price action and the only two things that seem to be in the actual price are the cash and the EVLT biz. At least that would explain the ultimate rise in the pps on the day. I suspect this fda issue has been discussd at length inside Ango (companies usually are aware of possible fda negative action, even if they hope for the best). And that has held the share price down after the last Q results were out. As for IRE, at least the need for a software fix doesn't screw up the US trials, as fda has been so slow there. US new sales likely go mostly into backlog and are deferred... doesn't affect probes.
Seems a waste of efforts though, this kind of software is pretty standard in thermal and radiation treatment planning... so a 510k should be sub 3 months anyway. Then again, hard to escape the feeling "someone" in the fda is purposely trying to keep IRE off the market as long as possible...
My guess is that some drug companies have gotten to someone inside the FDA. Maybe a stock trader inside the FDA is long some cancer drug. A WSJ article last year bemoaning off label use of the Nanoknife could have been planted by a liver cancer drug company. Like it or not but the Nanoknife technology could hurt drug company sales.
Nothing surprises about the FDA and that is why medical equipment companies are introducing American products in Europe.