PainChek (ASX:PCK) said US healthcare law firm Nixon Law Group confirmed the PainChek device qualifies as a US Food and Drug Administration (FDA)-regulated medical device for the purposes of Remote Therapeutic Monitoring (RTM) reimbursement claims in the US to the Centers for Medicare & Medicaid Services, according to a Thursday Australian bourse filing.

The legal opinion confirmed that PainChek meets the statutory definition of a medical device under the US Federal Food, Drug, and Cosmetic Act and was granted De Novo classification by the FDA.

Its device allows for assessing pain in non-verbal dementia patients in long-term care settings with musculoskeletal issues.

The firm said it now operated two business models in the US, an existing business-to-business software-as-a-service offering to long-term care facilities, as well as a new RTM reimbursement model. It will formally launch its RTM initiative to customers and partners at HIMSS 2026 Global Health Conference in Las Vegas in March.