PainChek’s FDA Status Opens US RTM Door but Faces Market Adoption Challenges

FDA Clearance Opens Door to US Reimbursement

PainChek Limited, the Australian developer of an AI-powered pain assessment tool, has achieved a significant regulatory milestone. An independent US legal opinion has confirmed that PainChek qualifies as an FDA-regulated medical device under the Remote Therapeutic Monitoring (RTM) reimbursement framework administered by the Centers for Medicare & Medicaid Services (CMS). This follows the company's recent FDA De Novo classification, a pathway reserved for novel medical devices, which officially recognises PainChek’s device as compliant with US federal regulations.

This regulatory validation is more than a compliance tick; it unlocks a lucrative reimbursement channel for healthcare providers using PainChek to monitor musculoskeletal pain, particularly in non-verbal dementia patients residing in long-term care facilities. Until now, there was no FDA-cleared device capable of objectively assessing pain in this vulnerable cohort, leaving a significant gap in clinical care and reimbursement eligibility.

Tapping into a Multi-Billion Dollar Opportunity

The RTM reimbursement model allows healthcare professionals to claim monthly payments for remotely monitoring therapeutic data, including pain levels, when collected via an FDA-approved device. Musculoskeletal conditions, which affect over 70% of long-term care residents with dementia, represent the largest and fastest-growing segment within this framework. Market research projects the US RTM market to reach approximately US$3 billion annually by 2030, positioning PainChek at the forefront of a rapidly expanding sector.

PainChek’s CEO, Philip Daffas, emphasised the clinical and economic significance of this development, noting that the device not only facilitates accurate pain detection but also aligns with billing requirements, enabling healthcare professionals to claim reimbursements effectively. This dual benefit enhances PainChek’s appeal as both a medical and commercial solution.

Dual US Business Models and Strategic Expansion

Currently, PainChek operates two complementary US business models. The first is a B2B software-as-a-service (SaaS) offering to long-term care facilities, priced at around US$50 per bed annually, targeting a market opportunity estimated at US$150 million per year. The second, newly enabled by RTM reimbursement eligibility, allows healthcare professionals to generate recurring revenue through monthly CMS claims linked to PainChek’s clinical use.

Further strengthening its competitive position, PainChek holds a US patent extending to 2038 covering pain assessment and therapeutic monitoring, creating a substantial barrier to entry. The company is actively collaborating with partners servicing over 25,000 US long-term care facilities to accelerate adoption under the RTM framework. Additionally, PainChek is pursuing FDA indication expansions to include home care settings, which would broaden the addressable market beyond institutional care.

Looking Ahead to HIMSS 2026 and Beyond

PainChek plans to formally launch its RTM initiative at the HIMSS 2026 Global Health Conference in Las Vegas this March, a key event for healthcare technology innovation. This launch will provide further clarity on the company’s go-to-market strategy and commercial partnerships. Investors and industry watchers will be keen to see how quickly PainChek can translate regulatory and reimbursement approvals into tangible market penetration and revenue growth.

With a unique product addressing a critical unmet need, regulatory validation, and a clear reimbursement pathway, PainChek is well positioned to capitalise on the burgeoning US RTM market. The coming months will be pivotal in demonstrating commercial traction and scaling its innovative pain assessment technology across the US healthcare landscape.