PainChek Ltd (ASX: PCK), the developer of the world’s first smart device-based pain assessment and monitoring application, has announced it has received a De Novo grant from the US Food and Drug Administration (FDA) for its PainChek® Adult App. This marks a significant milestone for the company, establishing PainChek as the first and only regulated medical device for pain assessment in the US, specifically for individuals who cannot reliably verbalise their pain. The FDA has also created a new product code, SGB, formally recognising PainChek as a unique and first-of-its-kind medical device.
This regulatory clearance opens access to the substantial US aged care market, encompassing over 3 million long-term care beds and an initial addressable market opportunity exceeding US$100 million annually. The company’s clinical trial conducted in the US over the past two years provides local clinical data to address US market acceptance. Strategic integration partnerships have been established with PointClickCare and Eldermark, covering approximately 60% of the US and Canadian long-term care market.
PainChek is now positioned for immediate commercial rollout in the US, supported by these strategic partnerships and a reseller agreement with Eldermark to accelerate market entry and sales growth. The company is actively pursuing business development opportunities through resellers and direct channels, further enhanced by its participation in upcoming US aged care conferences. The FDA De Novo classification also streamlines the pathway for rapid regulatory clearances in additional market segments, including home care and hospitals.
CEO of PainChek, Philip Daffas, hailed the FDA De Novo clearance as a transformative achievement, positioning the company to enhance pain assessment and management in the world’s largest healthcare market. The company is also growing its US commercial team and is backed by patent protection in major international markets, including the US, EU, UK, Japan, and China.
