I recently listened to the programme on the ABC about the major...

I recently listened to the programme on the ABC about the major holes (weaknesses) in the Eur0pean and other countries certification processes for medical devices. I can understand the reluctance of many medical specialists in using devices unless there is US FDA approval. This may also be the attitude in other ares such as with Technogas. (I think it is to be regarded as a device if approved).
The Medical Malpractice of US medical specialists are likely to not cover malpractice liability arising unless the device or procedure is approved by the FDA. That would also flow through to private specialists in for example in Australia. Having completed a UK Insurer's form requesting malpractice insurance for an Australian activity, insurance coverage would be denied where there is no US FDA approval.
Just listen to / watch the ABC programmes and you will see that US FDA approval is a necessary requirement to gaining acceptance from the conservative medical profession.