FDA Clearance Puts PainChek on Track—but US Market Risks Remain

Global Reach and Proven Adoption

PainChek, an AI-driven pain assessment medical device company, continues to expand its footprint with over 115,000 contracted licences across more than 1900 aged care facilities worldwide. As of January 2026, the company has facilitated more than 17 million pain assessments, primarily focused on residents who cannot reliably communicate their pain, such as those with dementia.

Operating on a pure software-as-a-service (SaaS) business model, PainChek reported $5.6 million in contracted annual recurring revenue (ARR), with $4.0 million already implemented. The company boasts gross margins exceeding 80%, underpinned by long-term customer contracts, with nearly 60% of implemented licences held for over three years.

FDA Clearance Opens US Market Doors

In a significant regulatory milestone, PainChek received FDA De Novo clearance in October 2025. This clearance classifies PainChek as a medical device, allowing it to be sold in the United States, the world's largest healthcare market. The approval also grants access to Medicare reimbursement pathways through Remote Therapeutic Monitoring (RTM) codes, which are currently being assessed for a new PainChek-specific CPT code with a decision expected by April 2026.

This development unlocks a substantial addressable market, estimated at over $3 billion annually, spanning aged care and home care sectors where millions of dementia patients reside. The company’s technology uniquely addresses a critical barrier in RTM reimbursement – objectively detecting pain in non-verbal populations, enabling healthcare providers to bill for monitoring and managing musculoskeletal (MSK) conditions effectively.

Innovative Business Models and Revenue Streams

PainChek is launching a dual US market strategy. The core SaaS B2B model continues to supply its FDA-cleared device under licence agreements, while a new RTM reimbursed model targets qualified healthcare professionals (QHCPs) who can bill Medicare for pain assessment and management services. This RTM model introduces a predictable, per-member-per-month (PMPM) fee structure, designed to deliver strong return on investment for providers and scalable revenue for PainChek.

The company plans to unveil this RTM business model at the HIMSS conference in Las Vegas in March 2026, aiming to showcase the financial benefits of enabling RTM reimbursement codes. PainChek is also actively negotiating with CMS for additional CPT codes to further expand reimbursement opportunities.

Strong Pipeline and Future Growth

PainChek’s qualified sales pipeline stands at $1.9 million ARR, spanning the US, UK, Australia/New Zealand, and Canada. The US sales team is currently qualifying an additional 30,000 licence opportunities, signaling robust demand. The company’s patented technology and alignment with RTM claims processes provide competitive protection in the US market until 2038.

With a proven SaaS model, high gross margins, and new reimbursement channels opening, PainChek is well-positioned to accelerate growth and deepen penetration in the lucrative US healthcare sector.