PainChek has achieved a major global milestone, receiving a US FDA De Novo grant for the PainChek® Adult App, making it the first and only regulated medical device in the United States for assessing pain in people living with moderate to severe dementia.
This achievement is a turning point for pain management in long-term care. It means US care teams can now access validated, AI-enabled pain assessment for people living with moderate to severe dementia, supporting improving outcomes and quality of life for residents.
Highlights from the September 2025 quarter:
- FDA De Novo grant received for the PainChek® Adult App, the first pain assessment technology of its kind approved for use in the US, and paving the way for use in over 3 million long-term care beds across the US.
- 14.6 million PainChek® assessments completed globally, up 97% on the previous year.
- 115,770 contracted licences across 1,900+ aged care and home care facilities in Australia, New Zealand, the UK, and Canada. Included in this total are 5,244 licences with home care providers, a fast-growing market for PainChek.
- Strong customer retention (85%+), showing the continued confidence providers have in the difference our technology makes to care quality and pain management.
- Continued positive clinical outcomes, including fewer falls, lower use of antipsychotic and analgesic medications, and improved wellbeing.
- First US client, Jewish Home Family, signed within days of FDA De Novo grant, with rollout planning now underway.
- PainChek Infant now available on both iOS and Android, supported by new partnership with CPR Kids, a Certified Social Enterprise that empowers families and carers to prevent, recognise and respond to childhood illness and injury.
North America: A new chapter for pain management
PainChek has entered an exciting new phase in North America, following the FDA De Novo grant of the PainChek® Adult app, making it the first and only regulated medical device in the US designed to assess pain in those living with moderate to severe dementia.
In the US, PainChek has signed its first commercial agreement with Jewish Home Family, a leading long-term care provider in New Jersey, and continues to build strong relationships with leading technology partners including PointClickCare, Eldermark and Yardi. These integrations will enable seamless adoption and help care teams embed pain assessment directly into their daily workflows.
PainChek also presented and exhibited at major US care conferences this quarter, including the AHCA/NCAL Convention and Expo in Las Vegas, which brought together more than 3,000 long-term care professionals, and the 2025 LeadingAge Annual Meeting & Global Ageing Network Conference in Boston, which attracted over 7,000 delegates. Both events generated strong engagement and new opportunities, building awareness of PainChek’s proven impact and readiness for large-scale adoption across the US.
In Canada, PainChek continues to build momentum. There are now 970 contracted licences, with 145 active subscriptions since July. PainChek recently celebrated the opening of its North American Headquarters in Edmonton, in partnership with Edmonton Global, with the Mayor of Edmonton and Alberta Health Ministers in attendance.
The team also co-presented with Sherwood Care and St. Michael’s Health Group at the Alberta Continuing Care Association (ACCA) Conference, showcasing the clinical and operational benefits these providers have seen since adopting PainChek® in 2023. The presentation received overwhelmingly positive feedback and generated strong interest from small to large long-term care providers across Canada.
With growing awareness, strong partnerships and proven clinical impact, PainChek is well positioned to support care organisations across North America in delivering more consistent, person-centred care.
Australia and New Zealand: Expanding best practice across care settings
PainChek continues to grow across aged care in Australia and New Zealand, with 71,759 implemented licences representing around 30% of the residential aged care sector.
A major milestone this quarter is with Catholic Healthcare (CHL), which provides care across NSW and QLD. PainChek is now their primary pain assessment tool across both residential and home care services, supporting staff to provide consistent, high-quality care for thousands of residents and clients. This is the first large provider that has implemented PainChek® across all of its care services, highlighting the growing role of our app in home care as well as aged care facilities.
PainChek also exhibited at the Ageing Australia National Conference on the Gold Coast, attended by over 2,300 healthcare professionals, and connected with more than 20 new organisations looking to enhance pain management across their services.
United Kingdom: Delivering measurable impact across care and hospitals
PainChek continues to support care teams across the UK, with 43,041 contracted licences.
Independent evaluation through the Scottish Care Inspectorate pilot has confirmed significant positive outcomes of PainChek®, including:
- Up to 40% reduction in falls
- Up to 27% reduction in dependency and care needs
- A 25% decrease in analgesic use
- A 33% decrease in antipsychotic prescriptions
These outcomes translate into both better care for residents and a projected economic benefit of £66 million across 23,000 residents, representing an estimated 10:1 return on investment. The Scottish government is now reviewing these results to support wider adoption across Scotland’s 38,000 aged care beds.
In hospitals, the Edinburgh Hospital TrakCare pilot with InterSystems has progressed to Phase 2 of a wider rollout, following verified time savings in Phase 1. This work will support NHS Lothian’s 21 hospitals, including four major teaching hospitals, helping nurses save time while improving pain management.
PainChek also showcased its solutions at the Birmingham Care Show in October, engaging with care providers nationwide and generating interest from over 60 organisations: the most successful Care Show for PainChek in the UK to date.
PainChek Infant: Progress in making infant pain visible
PainChek Infant is now available on the Apple App Store and Google Play, helping parents and caregivers identify the likelihood of pain in babies aged 1-12 months, track it reliably and make more informed care decisions.
This quarter, Sasha Grant joined as PainChek Infant’s Head of Growth, bringing experience from global brands like Expedia, eBay and Wiki Camps to expand awareness and improve user experience.
In addition, PainChek has formalised a partnership with CPR Kids, a Certified Social Enterprise dedicated to giving families and carers the skills to prevent, recognise and respond to childhood illness and injury.
As part of this collaboration, CPR Kids will conduct a clinical review of the PainChek Infant app, helping refine the app’s guidance so that families have clear, trustworthy support when caring for babies in pain. Other initiatives include the co-development of parent and clinician pain education materials, and professional engagement activities such as an Educator Day introducing the app to CPR Kids’ nursing educators and trainers.
Integrations: Connecting care systems for better outcomes
PainChek has been working closely with integration partners to make pain assessment seamless, efficient and embedded into everyday care workflows.
With these integrations, PainChek® assessments are automatically sent to a provider’s care management, medication or eMAR system. This means care teams can access pain information in one place, reducing system switching and helping ensure consistent, timely pain management throughout the day.
Recent highlights:
- Person Centred Software (PCS): When PainChek identifies pain, a “must do” reassessment alert is now automatically generated in PCS, helping carers follow up promptly.
- Australia & NZ integrations: Workflow improvements with medication management partners are underway. MPS Connect integration is ready for release, and updates with BESTMED have been developed in collaboration with customers.
- UK integrations: Nourish released updates with improved functionality, and Ascom launched a new integration. The upcoming Whzan integration will link PainChek® assessments to the NEWS2 clinical workflow, making pain data visible to GPs, paramedics and other non-emergency medical professionals.
- North America: Building on the PointClickCare integration, work is underway with Eldermark and Yardi to bring PainChek® into US long-term care workflows.
Research and innovation: Shaping the future of pain assessment
PainChek continues to work with hospitals, universities and care providers to develop and validate tools that improve pain assessment and management. Current research projects include:
Hospital sector:
- Testing technology-driven pain assessment for older adults after orthopaedic surgery and during general hospital stays.
- Exploring nurse-led volunteer support programs to optimise outcomes for frail patients.
- Assessing pain in older adults with cognitive impairment in emergency departments.
- Evaluating the PainChek® App in the geriatric ward at Singapore General Hospital to ensure its feasibility and effectiveness.
German market:
A study at the University of Applied Sciences and Arts (HSBI) Bielefeld is validating the German version of PainChek® in aged care. Data collection is underway with 35 residents and is expected to be completed by December 2025, supporting planned market entry in 2026.
Looking ahead
With the FDA De Novo grant achieved, PainChek enters its next phase of growth, expanding access to best-practice pain assessment for millions of people globally. We’re proud to partner with providers who share our vision to deliver better, more person-centred care through innovative technology.
To learn how PainChek® could support best-practice pain management in your organisation,
book a session with our team.
