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PainChek Secures FDA Clearance, Expands US Market Presence

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PainChek Secures FDA Clearance, Expands US Market Presence

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PainChek Ltd ( (AU:PCK) ) just unveiled an update.

PainChek Ltd has received FDA De Novo clearance for its pain assessment device, granting it access to a $175 million AUD annual market in the US long-term care sector. The clearance positions PainChek for significant growth and expansion opportunities, including a potential $582 million AUD market through further regulatory pathways. The company has signed its first US commercial agreement and is actively building a sales pipeline, while also experiencing growth in its core markets and launching its Infant App in Australia.

More about PainChek Ltd

PainChek Ltd is a company that develops smart device-based pain assessment and monitoring applications. It focuses on providing solutions for pain assessment, particularly for individuals with moderate to severe dementia, and is expanding its market presence in the US, Australia, the UK, and Canada.

Average Trading Volume: 5,144,048

Technical Sentiment Signal: Sell

Current Market Cap: A$87.68M

For a thorough assessment of PCK stock, go to TipRanks’ Stock Analysis page.

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