channel 9 brisbane, page-25

Really can't understand why there is so much one up man ship going on the technicalities of what the wording means.
The device can be sold in Australia....no trials needed anymore.
Hazardous is on the ball i'd say.
The hospital has bought 12 devices for implants in prospective patients.
And it's a bridge to transplant (BTT)
Hospitals who are trained up can start implanting whenever the have the patients and that includes European hospitals.
Everybody should be happy (who hold that is)
NB....There are no experts on this thread.