It’s likely that they received FDA clearance on it, however do not have their claims locked up so they cannot release it without those claims and contingencies in places, this can take a little bit of marketing Braun which they are not experts on. I work in the medical device industry, and we get clearances all the time, where we can talk about things but are not ready for prime time because of this very thing ... they wouldn’t be able to even mention it if they didn’t have clearance already ...