The Challenge is only related to the RecoveryRx (as best I understand...if not, they surely would have said this).
In November, we will know if it gets ACCEPTED into the challenge. Which would be a very good thing!! But that is 5 months from now. IF selected into the Challenge, it sounds like the odds of clearance/approval/whatever you wanna call it are fairly good, it won't take very long, a few months, maybe 4-5, I do not know. But it has to get accepted to part of the Challenge first. Applying to BE in the challenge is the first step. Which they say they have done, or will be very shortly. They would not be filing a 510(k) along with their APPLICATION to be in the Challenge. That would not make sense...it is a very complicated process I assume to file the 510(k), and if the product doesn't even make the Challenge, there's no way it will get approval. Or, really, it still COULD, but seems like odds would go down a decent amount. And they would be doing this AFTER November, when they know if they get accepted or not.
The also said they intend to file the other 510(k) for musculoskeletal (as best I understand), and they said they will file by the end of the month.
Hope it does well.
Any talk, right now, of imminent approval of either device is premature at best. They have also said that a US partnership is partial contingent on approvals. Doesn't mean a partnership can't happen anytime, but until approval, the odds of that go down. That is what they implied IMO
AIMHO. GLTA. Peace.
