• Independent legal opinion confirms PainChek device qualifies for US Remote Therapeutic Monitoring reimbursement
• RTM reimbursement in US projected to be worth US$3bn per annum by 2030
• PainChek addresses a significant RTM barrier for healthcare professionals

PainChek Ltd has announced that it has received independent legal opinion confirming the PainChek device qualifies as an FDA-regulated medical device for the purposes of Remote Therapeutic Monitoring (RTM) reimbursement claims in the United States. The legal opinion, from leading US healthcare law firm Nixon Law Group, confirms that PainChek meets the statutory definition of a medical device under the US Federal Food, Drug, and Cosmetic Act (FD&C Act) and has been granted De Novo classification by the US Food and Drug Administration (FDA). As a result, the PainChek device is eligible to be used by US healthcare professionals when submitting RTM reimbursement claims to the Centers for Medicare and Medicaid Services (CMS). RTM reimbursement in the US is growing rapidly and is projected to be worth US$3bn per annum by 2030, with the assessment and management of musculoskeletal diseases being seen as the largest growth sector. PainChek addresses a significant RTM barrier for healthcare professionals, as until it was cleared as an FDA-approved medical device, there was no device available to diagnose or treat pain in individuals with moderate to severe dementia. PainChek resolves this issue by objectively detecting pain and linking pain scores to musculoskeletal diagnoses, providing the essential data sets required for healthcare professionals to make RTM reimbursement claims. PainChek will formally launch its RTM initiative to US customers and partners at the HIMSS 2026 Global Health Conference in Las Vegas.

PainChek has 115,073 contracted licences globally across over 1,900 aged care facilities, with an annual recurring revenue (ARR) of $5.6M once fully implemented. The company has implemented over 80,000 licences with an ARR of $4.0M as of end-January 2026.