Yes it needs FDA approval . GSS have limited approval for their...

Yes it needs FDA approval . GSS have limited approval for their Enteric product in the US , it can be used by around 8,000 certified labs . So far there are labs trialing and assessing the product and one major lab has opted to use the product and has placed repeat orders . Other products are going though the validation process to aquire FDA approval . I would hope once the FDA fully appreciates the tech they will pass future products without major scrutiny but we are talking about the FDA here . I think the EU and Australian markets are the short term goals it seems the EU are more willing to accept new / better tech . I do think as I have stated in previous posts once GSS obtains more EU /US approvals one of the big players will try to aquire GSS . This tech is the future in pathology industry and the major players won’t want to be left behind .