4DX is FDA and TGA cleared for XV LVAS.
The hardware scanner "Generation One" is based on the XVLVAS software otherwise NIH the US national institute of health which a government agency wouldnt purchase a machine thats not FDA approved yet. same here in AUS, AF said many times by this time next year we will have a scanner installed inside one of the hospitals scanning patients.
" Generation Two "scanner will include on top of XV LVAS the second software VQ the ventilation Perfusion which hasnt been cleared yet by any jurisdiction.
thats my personal opinion DYOR
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