Latest PCK News

Small caps did the heavy lifting this week, led by two big discovery stories in resources. Funding raises and takeover moves kept attention on who can pay for the next step, not just promise it.

A handful of healthcare names did the heavy lifting this week, driven by FDA wins, guideline upgrades, and big shifts in sales and cashflow. The flip side: several clinical-stage stocks fell hard as investors stayed picky about near-term proof and funding.

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.

PainChek has secured FDA De Novo clearance, enabling entry into the vast US healthcare market with a $3 billion Remote Therapeutic Monitoring opportunity. The company reports $5.6 million contracted ARR and a strong global footprint in aged care.

PainChek has secured FDA-regulated medical device status, enabling US Remote Therapeutic Monitoring reimbursement and opening a major US growth avenue. The company targets musculoskeletal pain management in non-verbal dementia patients, a largely underserved market.

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.

PainChek Ltd has achieved a pivotal FDA De Novo clearance for its AI-driven Adult pain assessment app, unlocking the US market and driving its annual recurring revenue to $5.6 million. The company also launched its Infant app, targeting a vast global market of pre-verbal children.

PainChek has secured FDA De Novo clearance for its Adult App, opening immediate access to a $175 million AUD US long-term care market and advancing its Infant App commercialization targeting a $15 billion AUD global opportunity.

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.