PainChek Breaks Ground with FDA Clearance and US Market Launch
PainChek Ltd has secured FDA De Novo clearance for its Adult App, marking a pivotal entry into the US long-term care market and setting the stage for global expansion including its Infant App.
- FDA De Novo clearance achieved for Adult App in October 2025
- First US customer secured with deployment underway
- $3.5M actual ARR with $2.1M pipeline and strong multi-year contracts
- Infant App regulatory cleared in multiple markets, targeting global consumer segment
- Operational break-even targeted in ANZ and UK by Q4 2026
FDA Clearance Opens US Market
PainChek Ltd, an innovator in AI-driven pain assessment technology, announced a significant milestone with the FDA granting De Novo clearance for its Adult App in October 2025. This regulatory achievement is notable as it establishes a new medical device classification, providing PainChek with a competitive moat and a potential five-year lead over rivals in the US long-term care market, valued at approximately A$175 million annually.
The De Novo pathway signals the FDA’s recognition of PainChek’s technology as novel and safe, a rare distinction in the AI/ML medical device space where most approvals rely on existing predicates. This clearance not only facilitates immediate US market entry but also accelerates regulatory prospects in other key regions such as Japan and Brazil.
Strong Commercial Traction and Strategic Partnerships
Following clearance, PainChek swiftly established a US subsidiary and core team, securing its first customer, Jewish Home Family in New Jersey, which has begun deploying the technology to enhance pain management for dementia patients. The company’s SaaS business model boasts over 115,000 contracted licenses across ANZ, UK, Canada, and initial US deployments, with actual annual recurring revenue (ARR) at $3.5 million and a robust $2.1 million pipeline.
Retention rates remain high with multi-year contracts covering 1,900 aged care facilities, and integration partnerships with major healthcare software providers like PointClickCare and Eldermark grant access to millions of beds. PainChek’s strategy includes expanding into home care and hospital markets, with FDA applications underway for these sectors.
Infant App Targets a Vast Global Market
Complementing its adult-focused technology, PainChek’s Infant App is the world’s first AI-enabled pain assessment tool for infants aged 1-12 months, designed for use by parents and non-medical carers. Already regulatory cleared in ANZ, EU, and UK, the Infant App addresses a global market of up to 400 million pre-verbal children annually. The company plans to finalize US regulatory clearance following the Adult App’s success and aims to scale commercial adoption from early 2026.
Looking Ahead – Growth and Operational Milestones
PainChek’s roadmap includes achieving operational break-even in ANZ and UK by the end of 2026, expanding US market penetration towards 10%, and broadening partnerships to cover 80% of the US long-term care beds. The company is also advancing new product developments targeting toddlers, vocalisation assessments, and disabilities, signaling a broadening of its AI-driven pain management portfolio.
With a seasoned leadership team boasting global healthcare and technology expertise, PainChek is well-positioned to capitalize on the growing demand for objective pain assessment tools in ageing populations worldwide.
Bottom Line?
PainChek’s FDA clearance and US launch mark a transformative step, but execution in a competitive and regulated market will be key to sustaining momentum.
Questions in the middle?
- How quickly can PainChek scale US sales to achieve meaningful market penetration?
- What is the timeline and likelihood for FDA clearance of the Infant App in the US?
- How will competitors respond to PainChek’s five-year regulatory lead and patent protections?
