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Can PainChek Secure FDA Clearance and Revolutionize US Pain Assessment?
8:46am on Thursday 5th of June, 2025 AEST
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Healthcare
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Can PainChek Secure FDA Clearance and Revolutionize US Pain Assessment?
8:46am on Thursday 5th of June, 2025 AEST
Key Points
Successful final FDA feedback meeting on De Novo clearance
Additional clinical data submission planned by end of June 2025
FDA committed to a clearance decision within 75 days post-submission
New US business development head appointed
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