Just my opinion but I think CZM have a good deal of experience...

Just my opinion but I think CZM have a good deal of experience at obtaining FDA approval for new medical equipment so I am not concerned. The sheath has been designed with FDA approval in mind, which is one reason it took so long and was quite difficult to get right.

So I think CZM will get there, and they know what they have to do. That doesn't mean the process will be faster than normal, but it may help. They have already been granted CE approval. Remember also that Mauna Kea's device is not the only one, OIL had a previous device although much inferior to the current product.