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PainChek Breaks Ground with FDA Clearance and US Market Launch
10:42am on Wednesday 26th of November, 2025 AEDT
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Healthcare
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PainChek Breaks Ground with FDA Clearance and US Market Launch
10:42am on Wednesday 26th of November, 2025 AEDT
Key Points
FDA De Novo clearance achieved for Adult App in October 2025
First US customer secured with deployment underway
$3.5M actual ARR with $2.1M pipeline and strong multi-year contracts
Infant App regulatory cleared in multiple markets, targeting global consumer segment
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