PainChek Advances Towards US Market Entry with FDA Clearance Progress

PainChek Ltd ( (AU:PCK) ) has issued an announcement.

PainChek Ltd has successfully concluded a meeting with the US FDA, agreeing on a revised timeline for the De Novo regulatory clearance of its pain assessment app. This milestone is crucial for PainChek’s entry into the US market, and the company is preparing to submit additional information to the FDA by the end of June 2025. With a projected clearance date by mid-to-late September 2025, PainChek is positioning itself to launch its Adult App in the US market later this year. The company has also strengthened its US market strategy by hiring a local Head of Business Development and securing partnerships with major healthcare providers.

More about PainChek Ltd

PainChek Ltd is a company specializing in the development of smart device-based applications for pain assessment and monitoring. Their flagship product, the PainChek app, is a regulatory-cleared medical device that combines AI technology with the Numerical Rating Scale to provide accurate and consistent pain assessments. The company operates globally, with regulatory clearance in multiple countries and contracts with over 1,800 aged care facilities.

Average Trading Volume: 1,400,062

Technical Sentiment Signal: Buy

Current Market Cap: A$106.8M

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