I can't find any approvals though I suspect they are working on that with Trilabs (based on previous news releases) who are specialized in helping companies with fda clinical trials.
They should be promoting as 'non approved' if they are marketing in the US.
Any FDA approval will likely require the de Novo pathway which takes a good 6 to 12 months after submission.
I can't find any approvals though I suspect they are working on...
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