Latest Painchek (ASX:PCK) News

PainChek Limited has appointed Sasha Grant as Head of Growth for its AI-powered Infant App, aiming to scale its presence in a $15 billion global market. Early Australian adoption shows promising conversion rates as the company prepares for international expansion.

PainChek Limited has confirmed FDA De Novo classification for its PainChek Adult App, promptly disclosing the material regulatory milestone to the ASX and signalling a significant step towards US market entry.

PainChek Limited has secured its first US customer, Jewish Home Family, just days after receiving FDA De Novo clearance for its AI-powered pain assessment app, marking a significant step into the $100 million US aged care market.

PainChek Limited has achieved a landmark FDA De Novo classification for its PainChek Adult App, positioning it as the first regulated medical device for pain assessment in the US aged care sector and opening a $100 million annual market opportunity.

PainChek’s UK pilot reveals significant clinical improvements and economic benefits, positioning the digital pain assessment app for broader adoption in Scotland and beyond.

PainChek Limited reported a 24% revenue increase to $4.8 million for FY25, narrowing its net loss by 7%, while progressing toward FDA clearance for its Adult PainChek App in the US and launching its Infant App in Australia.

PainChek Limited has secured a A$7.5 million placement to fuel its international expansion, with US FDA clearance for its adult pain assessment app expected imminently. The company reports strong license growth and a 26% revenue increase year-on-year.

PainChek Limited has raised A$7.5 million through a strongly supported placement to accelerate its US market entry following anticipated FDA clearance and expand its innovative AI pain assessment technology internationally.

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.

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.

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.

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.