PainChek Enters US Market with First Customer Following FDA Clearance

PainChek Ltd (ASX: PCK), the company behind the world’s first AI-powered medical device for pain assessment, has secured its first customer in the United States just days after receiving FDA De Novo clearance. The agreement, signed with Jewish Home Family, a leading senior care organisation in New Jersey, marks a pivotal moment in PainChek’s international expansion.

The three-year agreement includes an upfront payment and fast-tracked implementation, with training set to begin immediately. Jewish Home Family will adopt PainChek’s technology at its flagship facility, aiming to improve pain detection and management for residents with moderate to severe dementia.

PainChek’s entry into the US unlocks a significant opportunity, targeting a long-term care market that includes three million beds and represents an estimated initial addressable value of USD 100 million annually. With regulatory clearance now in place, PainChek is aggressively targeting this market with new business development hires and strategic integrations with platforms such as PointClickCare and Eldermark, which together serve roughly 60 percent of the US long-term care sector.

CEO Philip Daffas called the milestone a “transformative moment,” reinforcing the significance of the FDA’s endorsement and the early partnership with an influential care provider. The FDA's creation of a new product category (SGB) for PainChek’s Adult App affirms its position as a category-defining solution.

The company’s AI-driven app uses facial recognition and behavioural cues to assess pain in patients who cannot communicate it themselves. Already in use across more than 1,900 facilities worldwide with over 12 million assessments completed, PainChek is also expanding into home care and hospital markets.

PainChek will be showcasing its solution at major US industry events including the AHCA/NCAL Expo in Las Vegas and the LeadingAge Annual Meeting in Boston, furthering its mission to redefine pain assessment in the global aged care industry.