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How PainChek’s FDA Clearance Unlocks a $175M US Market and Infant App Boom
9:14am on Friday 31st of October, 2025 AEDT
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Healthcare
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How PainChek’s FDA Clearance Unlocks a $175M US Market and Infant App Boom
9:14am on Friday 31st of October, 2025 AEDT
Key Points
FDA De Novo clearance grants PainChek unique US long-term care market access
First US commercial agreement signed shortly after FDA approval
Global contracted licences grow 15.4% year-on-year with strong retention
Infant App launches in Australia targeting a $15 billion AUD market
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