Correct @Specstock101, from last annoucment:
FDA: We have engaged with the FDA for US regulatory approval and are awaiting feedback on regulatory classification for the PainChekTM App. We have designed the PainChekTM App taking into consideration the US geriatric pain assessment guidelines and are confident we can obtain FDA approval by the end of 2018.
Don’t be expecting FDA approval news until at least after June
PainChek General Discussion, page-228
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