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PainChek Secures FDA De Novo Clearance, Unlocking $100M US Aged Care Market

11:31am on Wednesday 8th of October, 2025 AEDT Healthcare
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PainChek Secures FDA De Novo Clearance, Unlocking $100M US Aged Care Market

11:31am on Wednesday 8th of October, 2025 AEDT
Key Points
  • First and only FDA-regulated pain assessment device in US aged care
  • New FDA product code 'SGB' created for PainChek’s unique technology
  • Initial US market opportunity exceeds $100 million annually
  • Strategic partnerships cover 60% of US and Canadian long-term care markets
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