PainChek Completes Submission for US FDA De Novo Regulatory Clearance for App; Shares Up 3%

MT Newswires Live

2025/07/21

PainChek (ASX:PCK) completed its final submission to the US Food and Drug Administration for de novo regulatory clearance for its PainChek Adult app, which includes its artificial intelligence pain assessment tool, as a medical device in the country, according to a Monday Australian bourse filing.

The company expects a final decision on the clearance within 75 days.

The firm added that US partner agreements were already in place to support the commercialization of the app.

PainChek's shares were up almost 3% in recent Monday trade.

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