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PainChek LtdASX: PCK

Final US FDA De Novo Clearance Submission Completed

Jul 20, 2025 at 11:22 PM EDT · Issued by PainChek Ltd

Filed with ASX · Jul 20, 2025 at 11:22 PM EDT

On 6ix: 6ix.com/news/final-us-fda-de-novo-clearance-submission-completed

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PainChek Ltd on 6ix

Earlier from PainChek

  • PainChek Reports Strong Quarterly Sales GrowthJul 2, 2025
  • PainChek has productive final FDA De Novo clearance meetingJun 4, 2025
  • PainChek partners with Eldermark to expand US market reachMay 26, 2025
  • R&D Tax Refund, FDA Review of Adult App & Infant App LaunchApr 15, 2025
  • PainChek completes Entitlement Offer raising AUD $5.1 mDec 16, 2024

Later from PainChek

  • Strongly Supported A$7.5m Placement to Drive Int. GrowthJul 28, 2025
  • Preliminary Final ReportAug 28, 2025
  • Compelling Clinical and Economic Results in Scottish PilotSep 16, 2025
  • Trading HaltOct 6, 2025
  • PainChek FDA Cleared to Commence Sales in US$100M US MarketOct 8, 2025
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