PainChek Submits Final US FDA De Novo Application for Adult App Clearance.

PainChek Ltd (ASX: PCK) has completed its final De Novo submission to the US FDA for regulatory clearance of its PainChek Adult App, a groundbreaking AI-powered medical device for assessing pain in individuals unable to self-report, such as those with moderate to severe dementia. A final decision is expected within 75 days, potentially by late September or early October 2025.

The company is strategically positioned for rapid commercialisation in the US, supported by established client relationships, key reseller partnerships, and a newly appointed US Head of Business Development. This move unlocks a US market opportunity exceeding $100 million annually, targeting the 2.9 million people in assisted and skilled nursing care. Upon initial clearance, PainChek aims to expand further into hospitals, home care, and infant pain assessment segments. With prior regulatory approvals in seven countries and over 12 million assessments completed, PainChek is poised for global growth in best-practice pain management solutions.

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