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PainChek® is a medical device: ALWAYS FOLLOW THE DIRECTIONS FOR USE. Landmark US FDA De Novo Grant received for PainChek Adult

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    2026

    22 July 2026 PainChek Receives $1.123 Million Tax Refund PDF 20 July 2026 US MedTech Leader Karen Holzberger Appointed CEO PDF 8 July 2026 PainChek Launches Major Platform Enhancement PDF 30 June 2026 Quarterly Activities/Appendix 4C Cash Flow Report PDF

    2025

    27 February 2026 Half Yearly Report and Accounts PDF 30 January 2026 PainChek Business Update PDF
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    PainChek® meets regulatory standards for use in Australia, New Zealand, Canada, Singapore, Malaysia, the United Kingdom, the European Union, and PainChek® Adult has been granted a De Novo classification by the US Food and Drug Administration (FDA) for its PainChek® Adult App. The FDA De Novo Grant number is DEN240073. The tool is included in the Australian Register of Therapeutic Goods (ARTG) under ARTG number 302794.

    PainChek® is a registered trade mark of PainChek in Australia, the United Kingdom, the European Union, and a trade mark in other jurisdictions.

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