EMV emvision medical devices ltd

EMvision Research Notes, page-2633

  1. 4,617 Posts.
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    A question for vintage and the rest of the brain's trust.

    All the talk, that I can recall anyway, has been about getting EMU approved by FDA so it can go onto the market later next year. But that Flying Doctor's clip that milk posted reminded me that EMU will need TGA approval to be sold in Australia (unfortunately health regulators are territorial). I have seen medtech companies focus on FDA over TGA or TGA over FDA. Has Scott Kirkland ever explained what the regulatory roll-out timeline of EMU will be in Australia? Those Flying Doctor workers seem to be assuming that EMU will be available for sale late next year but that will not be the case if the TGA process is not being run concurrently with the FDA process.

    Thanks in advance.
 
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