here is where we are at, page-14

Yes, I also got that impression from my talks with management.

When they provide the 'official' company update, I hope they can give us some indication as to the timing of the 510k approval process - ie whether or not it is likely to be fast-tracked etc.

Based on your update (and its 'confirmation' by jackfrost) I now wish I had the additional funds to buy into this dip. Won't last long given what you and jf have found out.