PainChek Targets FDA Decision by September, Prepares US Launch
PainChek has advanced its US regulatory approval process with a positive FDA meeting, setting the stage for a potential market debut of its pain assessment app in late 2025.
- Successful final FDA feedback meeting on De Novo clearance
- Additional clinical data submission planned by end of June 2025
- FDA committed to a clearance decision within 75 days post-submission
- New US business development head appointed
- Reseller agreements covering over 60% of US long-term care beds secured
Progressing Through Regulatory Hurdles
PainChek Ltd, an innovator in digital pain assessment technology, has taken a significant step forward in its quest to enter the US market. Following a productive final feedback meeting with the US Food and Drug Administration (FDA) on June 3, 2025, the company is preparing to submit additional clinical data by the end of June. This submission aims to address the FDA's remaining questions and is expected to be the last milestone before a regulatory decision.
The FDA has committed to delivering a final decision on PainChek’s De Novo regulatory clearance within 75 days of receiving this submission, projecting a potential clearance date in mid-to-late September 2025. This timeline offers a clear pathway for PainChek to launch its Adult App tailored for the US market later this year.
Strategic Market Preparation
Beyond regulatory progress, PainChek is actively laying the groundwork for commercial success in the United States. The company has appointed a local Head of Business Development to spearhead market entry efforts. Additionally, it has secured integration and reseller agreements with PointClickCare and ElderMark, two major players covering more than 60% of the approximately 3 million long-term care beds in the US.
These partnerships, combined with early client identification, position PainChek to rapidly scale adoption once FDA clearance is granted. The company’s technology, which combines artificial intelligence with clinical pain assessment, has already gained regulatory approval in several other regions, including Australia, Canada, and the European Union.
Innovating Pain Management
PainChek’s app addresses a critical need in healthcare by providing objective pain assessments for patients who cannot reliably self-report, such as those with dementia or other cognitive impairments. The technology uses AI to analyze facial expressions and other indicators, streamlining pain management and improving care quality.
With over 10 million digital pain assessments conducted globally and contracts with more than 1,800 aged care facilities, PainChek has demonstrated both clinical validity and market traction. Its expansion into the US market represents a pivotal growth opportunity, especially as the company also explores applications in home care and infant pain assessment.
Looking Ahead
The upcoming FDA decision will be a critical inflection point for PainChek. Success would not only validate its innovative approach but also unlock access to one of the world’s largest healthcare markets. Investors and industry watchers will be closely monitoring the final submission and regulatory outcome, as well as the company’s ability to convert its strategic partnerships into commercial momentum.
Bottom Line?
PainChek’s FDA milestone sets the stage for a transformative US market entry, with the final clearance decision looming.
Questions in the middle?
- Will the FDA grant De Novo clearance on schedule by September 2025?
- How quickly can PainChek scale adoption through its new US partnerships?
- What impact will US market entry have on PainChek’s global growth trajectory?
