PainChek Breaks Ground in the US with FDA Approval for Pain Assessment App

PainChek (ASX: PCK) has landed a landmark US regulatory breakthrough, receiving De Novo clearance from the Food and Drug Administration (FDA) for its AI-powered pain assessment app. This paves the way for the company to enter the world’s largest aged care market with an initial addressable opportunity of US$100 million per annum.

The FDA has granted PainChek a new product classification under the code “SGB”, recognising the application as the first and only regulated medical device for assessing pain in individuals unable to reliably self-report. The De Novo status confirms its uniqueness, creating a clear run at the American long-term care sector.

PainChek’s initial focus will be the 3 million long-term care beds across the US, but the opportunity stretches much further. With a favourable reimbursement and regulatory environment in place, the company expects rapid pathways into home care and hospital settings, potentially expanding its market opportunity to over US$582 million annually.

Chief Executive Philip Daffas described the FDA clearance as “a transformative achievement” that validates the company’s technology and opens the door to exponential commercial growth.

“We are now uniquely positioned to enhance pain assessment and management in the US, building on our established success in Australia and the UK,” said Daffas.

Strategic integration deals are already in place with two of the largest electronic health record providers in the US and Canada—PointClickCare and Eldermark—collectively covering about 60 percent of the North American long-term care market. A reseller agreement with Eldermark has also been signed to accelerate penetration and sales.

With operations live in over 1,900 aged care facilities globally, including Australia, the UK, and New Zealand, PainChek has already conducted over 12 million digital pain assessments. Its proprietary AI technology enables caregivers to detect pain through facial recognition and behavioural cues, even in individuals with severe dementia or communication challenges.

The FDA’s green light also gives PainChek a platform for faster regulatory clearance in other key markets including Japan, Brazil and the UAE, where FDA approvals can be leveraged to fast-track local authorisations.

To capitalise on this milestone, PainChek is scaling its US business development team. Head of Business Development Nick Garofoli and newly relocated executive David Allsopp are spearheading the US and Canadian expansion.

PainChek will showcase its solution at major industry events including the AHCA/NCAL convention in Las Vegas and the LeadingAge Annual Meeting in Boston, aiming to build awareness and forge further commercial partnerships.

With regulatory tailwinds and technology designed for a deeply unmet need, PainChek is well placed to become a category leader in AI-driven pain management.