PainChek has achieved FDA regulatory clearance enabling its device to qualify for US Remote Therapeutic Monitoring reimbursement, positioning the company for significant growth in the expanding US healthcare market. The company also reports strong global licence growth and a solid pipeline across multiple regions.
- FDA clearance confirms PainChek device qualifies for US RTM reimbursement
- US RTM market projected to reach US $3bn annually by 2030
- 115,000+ global contracted licences with 14.6% year-on-year growth
- Strong US sales pipeline and new customer agreements in skilled nursing facilities
- Cash reserves of $4.8 million and ongoing R&D investment
FDA Clearance Opens US Market Doors
PainChek Limited has announced a pivotal regulatory milestone with independent legal confirmation that its PainChek® device qualifies as an FDA-regulated medical device for Remote Therapeutic Monitoring (RTM) reimbursement claims in the United States. This clearance, granted under the FDA's De Novo classification, enables US healthcare professionals to submit RTM claims to Medicare and Medicaid, a critical step for commercial adoption in the lucrative US healthcare market.
The RTM sector in the US is rapidly expanding, with projections estimating a market value of US $3 billion per annum by 2030, driven largely by the assessment and management of musculoskeletal diseases. PainChek’s technology addresses a significant gap in this space, particularly for patients with moderate to severe dementia who have historically been underdiagnosed and underserved in pain management.
Global Licence Growth and Customer Retention
Globally, PainChek continues to build momentum with over 115,000 contracted licences across more than 1,900 aged care facilities, representing a 14.6% increase over the prior year. The company reports an annual recurring revenue (ARR) of $5.6 million once fully implemented, with 75,590 licences currently active generating $3.7 million ARR. Customer retention remains robust, with 59% of implemented contracts lasting three years or more, underscoring the platform’s value and stickiness in aged care settings.
Regionally, the company is seeing strong uptake in Australia and New Zealand, maintaining approximately 30% market penetration in residential aged care. The UK and Canadian markets also show promising growth, supported by ongoing research collaborations and integration partnerships that enhance PainChek’s clinical utility and workflow efficiency.
Expanding US Presence and Pipeline
In the US, PainChek has secured agreements with skilled nursing facilities and built a qualified sales pipeline of 30,000 licences targeting medium to large enterprise customers. The company has bolstered its North American team with experienced hires and is actively engaging prospects through key industry conferences and strategic marketing initiatives. The formal launch of its RTM initiative is scheduled for the HIMSS 2026 Global Health Conference in Las Vegas, a critical platform to accelerate market penetration.
Complementing its core offering, PainChek is advancing product development with updates to its infant pain assessment app and exploring innovative vocalisation-based pain detection technology. These initiatives aim to broaden the company’s addressable market and deepen clinical impact.
Financial Position and Outlook
Financially, PainChek reported modest revenue growth with recognised revenue of $1.69 million for the six months to December 2025, up 2% year-on-year. Cash reserves stood at $4.8 million at quarter-end, supported by recent option conversions and ongoing customer receipts. The company continues to invest in research and development, marketing, and expanding its sales footprint, particularly in North America.
While the infant app subscription revenue remains in early stages, PainChek is adopting a test-and-learn approach to pricing and marketing to optimize uptake. Integration partnerships worldwide are enhancing product stickiness and supporting compliance with evolving healthcare standards.
Strategic Positioning for Future Growth
PainChek’s unique position as the first FDA-cleared AI-driven pain assessment device for non-verbal populations, combined with its expanding global footprint and strong customer retention, sets the stage for accelerated growth. The upcoming HIMSS conference and ongoing clinical validations will be key catalysts to watch as the company seeks to convert its pipeline into revenue and scale its presence in the US and other international markets.
Bottom Line?
With FDA clearance secured, PainChek is poised to transform pain management in the US, but execution on its RTM rollout will be critical to unlocking its full market potential.
Questions in the middle?
- How quickly will PainChek convert its US sales pipeline into recurring revenue?
- What impact will the new infant app pricing strategy have on subscription growth?
- How will integration partnerships influence customer retention and expansion globally?