It was interesting to see the comment that the RECELL kits are used in Western Australia. They are (or have been used) at the Concord Burns centre of the Concord Hospital in Sydney Australia (my wife used to work at the hospital and was aware). It was used on burns from the Bali bombing terrorism events.
Some on these recent threads have made reference to insurance / liability. My thoughts are
due to medical malpractice liability and insurance. The risk of doctors to be sued and the resultant claims liability. Insurers may only cover products that have formal FDA or approval in other countries which generally rubber stamp the US FDA after reviewing the evidence and basis.
Public hospitals in Australia also have state government based medical indemnity arrangements for salaried medical staff (not private doctors). This risk is then reinsured by the government to the global medical insurance / casualty liability markets.
This is why the FDA approval for AVH is such a big thing.
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