PainChek Ltd (AU:PCK) has released an update.
PainChek Ltd is advancing its US market entry strategy with the successful completion of a validation study for its Adult App, paving the way for a November 2024 FDA De Novo submission. The positive results align with previous studies and could lead to PainChek becoming the first FDA-cleared pain assessment tool for aged care residents in the US. This potential clearance is expected to significantly expand PainChek’s market reach in the US, offering a substantial revenue opportunity.
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