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PainChek Nears FDA Nod, Eyes $100M US Market for Dementia Pain App

PainChek has completed its final FDA submission for the PainChek Adult App, targeting the US long-term care market with a potential $100 million annual opportunity. A regulatory decision is expected within 75 days, setting the stage for rapid commercialisation.
Ada Torres
21 July 2025

PainChek Accelerates Global Reach with 10% Revenue Growth in Q2

PainChek Limited reports a robust quarter with a 10% rise in annual recurring revenue and expanding global client base, underpinned by strong licence retention and positive clinical validation.
Ada Torres
3 July 2025

PainChek Nears US FDA Clearance, Eyes Market Launch by Year-End

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.
Ada Torres
5 June 2025

PainChek Teams with Eldermark to Unlock US Long-Term Care Market

PainChek Limited has secured a pivotal reseller and integration deal with Eldermark Software, positioning its AI-driven pain assessment app for a major US market rollout pending FDA approval.
Ada Torres
27 May 2025

PainChek Nears FDA Clearance, Launches Infant App, and Expands Global Reach

PainChek Limited reports strong progress toward FDA De Novo clearance for US market entry, launches its Infant App in Australia, and achieves robust global licence growth with a 30% year-on-year revenue increase.
Victor Sage
30 Apr 2025

PainChek Advances FDA Clearance and Expands Global Market Reach in Q4 2024

PainChek Ltd reports robust growth with 100,000 contracted licences globally and positive FDA clearance progress, alongside a promising launch of its Infant App targeting a vast new market.
Ada Torres
31 Jan 2025