Painchek Ltd

PainChek Receives Historic FDA De Novo Approval for First Regulated Pain Assessment Device in US Market

- PainChek Ltd received FDA De Novo classification for its PainChek Adult App, establishing it as the first and only regulated medical device for pain assessment in the US for individuals who cannot reliably verbalize their pain. - The regulatory clearance opens access to a substantial US aged care market with over 3 million long-term care beds and an initial addressable market opportunity exceeding US$100 million annually. - Strategic integration partnerships with PointClickCare and Eldermark cover approximately 60% of the US and Canadian long-term care market, positioning the company for immediate commercial rollout. - The FDA has created a new product code (SGB) formally recognizing PainChek as a unique and first-of-its-kind medical device, streamlining pathways for rapid regulatory clearances in additional market segments.