PainChek (ASX:PCK) submitted a De Novo application with the US Food and Drug Administration (FDA) for the PainChek Adult app following "positive" US-based validation study results, according to a Wednesday filing with the Australian bourse.

A De Novo application is a marketing pathway for new medical devices, the filing said.

PainChek Adult is a pain assessment tool designed for aged care residents with moderate to severe dementia, according to the filing.