Nope. They'll have to go for FDA approval, irrespective of...

Nope. They'll have to go for FDA approval, irrespective of whether they have TGA or CE, which won't mean much to the FDA. That being said (and I think someone has brought it up previously) they may piggy back with a partner to speed up any FDA approval. The FDA have tightened things up big time too, given the recent recall of Alere's PT/INR device. While this doesn't necessarily impact Bodytel per se, it may be subject to much more scrutiny than per normal.

I have just read your addendum. Given they have CE Mark, I'm pretty certain this does indeed count towards TGA approval.

Happy to be corrected on the above