Why PainChek®?

FDA De Novo granted (DEN240073)

A unique, first-of-its-kind app-based medical device for US long-term care.

Clinically validated in the US

Validated through a pivotal clinical study in leading US skilled nursing facilities (SNFs).

Globally trusted

Proven over clinical use in Australia, New Zealand, the UK, and Canada since 2017.
12 million+ pain assessments completed worldwide.

Compliance

Supports compliance with CMS MDS 3.0 requirements, and federal and local pain management guidelines.

Staff empowerment

Equips healthcare teams with objective insights to guide informed, personalized care.

Seamless integration

Point-of-care, time-stamped assessments flow directly into eMAR and EHR platforms in real time.

“As an organization that is committed to, and focused on, the care of older adults, PainChek will play a meaningful role in enhancing the work that we do. It will have a positive impact on quality of life for our elders while helping our staff to better understand and effectively treat the residents.”

– Carol Silver-Elliott, President and CEO, Jewish Home Family

PainChek assessment screens

How PainChek® works

Available on smartphones and tablets, PainChek® uses evidence-based AI technology to automatically detect facial micro-expressions that indicate pain, along with digital checklists to record carer observations of other pain-related features.

All assessment data (but no facial images) is securely stored in PainChek®’s cloud portal, enabling continuous tracking of pain trends and treatment effectiveness.

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PainChek® qualifies as an RTM-eligible medical device

For the first time, US healthcare providers can now claim reimbursement for pain monitoring through CMS, using PainChek®. This creates a new pathway to monitor and manage musculoskeletal pain in people with moderate to severe dementia who cannot reliably self-report their pain.

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Transforming pain management globally

Across multiple studies and care settings in Australia, New Zealand, the UK, and Canada, PainChek® has consistently delivered measurable clinical outcomes:

Medication optimization: Reduced use of analgesics, antipsychotics, antidepressants, anxiolytics, and hypnotics

Resident well-being: Improved nutrition, increased mobility, reduced dependency, and improved quality of life

Safety and care quality: Fewer falls, reduced distress, and improved staff confidence in pain assessment

Operational benefits: Improved care efficiency and significant cost savings

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Scottish Government-funded pilot: Key outcomes

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REDUCTIONS:

25% reduction in analgesic use

40% reduction in falls

33% reduction in antipsychotic use

27% reduction in the use of anxiolytics and hypnotics

27% reduction in dependency scores

21% reduction in antidepressant use

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INCREASE IN BMI SCORES

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HIGH WORKFORCE APPROVAL

With a large majority of staff reporting PainChek® as an effective digital pain management solution

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ESTIMATED ~£66 MILLION COST SAVINGS

For the Scottish aged care system over five years

Scottish Government-funded pilot: Key outcomes

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25% reduction in analgesic use

40% reduction in falls

33% reduction in antipsychotic use

47% increase in BMI scores

27% reduction in the use of anxiolytics and hypnotics

27% reduction in dependency scores

21% reduction in antidepressant use

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High workforce approval, with a large majority of staff reporting PainChek® as an effective digital pain management solution

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Estimated ~£66 million cost savings for the Scottish aged care system over five years

Integration partners

PainChek’s rapidly expanding integration ecosystem includes 30+ leading technology partners worldwide, ensuring PainChek® works where your workflows live.

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Free report: Prevention vs Reaction

Why leading care providers are rethinking their approach to pain management Body: See the clinical and financial case for shifting from reactive to proactive pain management in long-term care, and the measurable outcomes it delivers.

DOWNLOAD THE REPORT

Discover how PainChek® can improve pain management and compliance at your organization.

Contact us today or call 1 800 720 7504.

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PainChek® meets regulatory standards for use in Australia, New Zealand, Canada, Singapore, Malaysia, the United Kingdom, the European Union, and PainChek® Adult has been granted a De Novo classification by the US Food and Drug Administration (FDA) for its PainChek® Adult App. The FDA De Novo Grant number is DEN240073. The tool is included in the Australian Register of Therapeutic Goods (ARTG) under ARTG number 302794.

PainChek® is a registered trade mark of PainChek in Australia, the United Kingdom, the European Union, and a trade mark in other jurisdictions.

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