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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
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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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