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PainChek Secures FDA De Novo Clearance, Unlocking US Market Potential
3:11pm on Thursday 16th of October, 2025 AEDT
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Healthcare
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PainChek Secures FDA De Novo Clearance, Unlocking US Market Potential
3:11pm on Thursday 16th of October, 2025 AEDT
Key Points
FDA grants De Novo classification for PainChek Adult App
New FDA product code 'SGB' created to recognise PainChek as a medical device
Price movement in PCK shares preceding announcement
PainChek requested trading halt to prepare disclosure
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