The US Food and Drug Administration (FDA) has granted De Novo classification for the PainChek® Adult App – establishing a new FDA product code and formally recognising it as a unique, first-of-its-kind medical device for pain assessment.
This landmark decision validates the PainChek® Adult App as an evidence-based innovation for people living with moderate to severe dementia, and paves the way for use in over 3 million long-term care beds across the US.
With established integrations through PointClickCare and Eldermark, PainChek® is set to support providers across the sector in improving outcomes and quality of life.
The FDA De Novo pathway
With no comparable device on the US market, PainChek® underwent the FDA’s De Novo review, requiring evidence of safety and effectiveness to establish a first-of-its-kind, new category medical device.
Results from the US Validation Study showed PainChek® demonstrated strong agreement with the internationally recognised Abbey Pain Scale, delivering accurate pain category assessments and superior test-retest reliability. It performed consistently across different resident demographics (age, gender, race, and ethnicity) and device platforms, with statistical validation further confirming its accuracy and clinical strength.
Philip Daffas, CEO and Managing Director of PainChek, commented:
“This FDA De Novo clearance is a transformative achievement for PainChek, uniquely positioning us to enhance pain assessment and management in the world’s largest
healthcare market. It validates our innovative technology and provides the foundation for accelerated US market growth, building off our established success in Australia and the momentum we’ve recently achieved in the UK.“I also want to thank the FDA for their continuous guidance through this unique De Novo regulatory classification grant and to my team and our research collaborators for their outstanding efforts.”
Interested to learn more about how PainChek® can improve pain management and compliance in your facility? Contact our team today.
