Blue, thanks for posting that and making my point.
There's NOTHING in front of the FDA to approve. There's just a promise that they're "committed". Commmitted? It's been almost a year since they were REJECTED BY THE FDA for that 1/2-butted FAILED attempt at the 510(k) and they've accomplished NOTHING with the FDA in all that time. Not even the meeting they promised. Why not? How's that "Committed"??
Furthermore, I believe because of their admitted LACK OF FINANCING, there will NEVER be anything in front of them to approve.