PainChek Nears FDA Submission Milestone

PainChek Ltd (AU:PCK) has released an update.

PainChek Ltd is nearing completion of its FDA de Novo submission for the PainChek Adult App, targeting the US Aged Care market—the largest globally with significant revenue potential. The company has completed the majority of submission requirements, including a US clinical validation study, and anticipates a major milestone with potential FDA clearance. This advancement could pave the way for broader use in various market segments and serve as a predicate for the PainChek Infant App.

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