PainChek® partners with the Melbourne Murdoch Children’s Research Institute (MCRI) for Infant App PainFaces Study
In this new study, which is expected to commence within days, the pain scores derived using the PainChek® Infant App will be compared to those obtained using observational children’s pain assessment tools by two independent assessors in approx. 100 infants undergoing painful procedures within the ED
Results and lessons from the research will support applications for regulatory approval of PainChek® Infant’s App with the Therapeutics Goods Administration (TGA), CE Mark, Europe, and the Food and Drug Administration (FDA) in the USA.
The first paragraph above says it is a STUDY. Not trial of the app.
The second paragraph says the they are comparing scores of the Infant App against the two independent assessors. It is like, see where they agree, and where they do not. So both parties are on trial here in a sense. And I think where they agree, they will adopt and use. While where they don't agree, maybe a bit more work to be done to prove up who is right and wrong.
Then the third paragraph says results and lessons from research will be used to apply for regulatory approvals.
Well, the more I read it, the more I think this is going to be a slam-dunk outcome. After all, since these assessors method is already in used, so where both the app and the assessors agree, then that part of the app will be approved. So really, what I am saying is this is merely a process to gain regulatory approval rather than a trial to see if it should gain regulatory approval.
If I am right, then it is only a matter of when rather than if the app will gain approval and be released to the market in general
