Hi everyone,I thought you might be interested in this article:...

Hi everyone,

I thought you might be interested in this article: https://blog.techinvest.online/news/painchek-expands-in-us-as-ai-pain-detection-gains-global-traction

PainChek Ltd (ASX: PCK) has delivered a strong quarterly update, with notable progress in its US FDA regulatory approval, a growing global user base, and a strategic push into home care and infant pain assessment markets. With a $5.1 million capital raise secured, the company is well-positioned for its next phase of expansion.

A major milestone for PainChek is its US FDA De Novo regulatory submission, which, if approved, will make its adult pain assessment app the first FDA-regulated tool of its kind in the US. The company received confirmation from the FDA that its submission was complete, with a decision expected by May 2025.

CEO Philip Daffas expressed confidence in the PainChek application, noting the strength of the clinical validation results and was pleased that the same FDA executive who initially reviewed PainChek’s application in 2019 and the subsequent pre-submission supplements will oversee the review. “This provides us with confidence PainChek will soon become the first and only FDA regulated pain assessment app for this patient cohort to enter the US market,” Daffas said.The US aged care market represents a $100 million annual opportunity, and PainChek is already working with potential US partners to establish market entry strategies.

Note: I was not paid to write this article.