Latest Healthcare It News

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.

Lumos Diagnostics reported a 12% revenue increase for FY25 and inked a landmark US$317 million exclusive distribution deal for its FebriDx test, while advancing its FDA CLIA waiver application.

Tryptamine Therapeutics has begun recruiting patients for a pioneering clinical trial testing IV-infused psilocin combined with psychotherapy to treat Binge Eating Disorder, aiming to deliver faster and more controlled treatment outcomes.

Australian Unity Limited has agreed to acquire Plena Healthcare for $70 million, significantly scaling its Home Health services and workforce. The move aims to create one of Australia's leading integrated healthcare providers, pending regulatory approval.

Mesoblast has reported a strong commercial debut for Ryoncil, the first FDA-approved mesenchymal stromal cell therapy for pediatric steroid-refractory acute graft-versus-host disease, generating US$13.2 million in gross revenue in its initial quarter. The company is advancing regulatory and clinical milestones while expanding insurance coverage across the US.

4DMedical has renewed its three-year contract with the University of Michigan Medical Center, reinforcing its foothold in US respiratory imaging. Alongside, a pivotal clinical study validates its technology’s ability to detect early lung disease, while a substantial Australian grant boosts its AI research.

McPherson’s Limited anticipates FY25 revenue around $139 million with a strong second-half EBITDA rebound, while its strategic shift to third-party wholesalers sets the stage for significant EBIT gains in FY26.

Adherium Limited has successfully completed a $4.49 million entitlement offer, combining institutional and retail components, to fund expansion of its Hailie® digital respiratory monitoring platform.

Lumos Diagnostics has locked in a A$5 million secured loan facility to support working capital as it advances toward FDA CLIA waiver for its FebriDx® test, complementing a landmark US distribution deal.

Clarity Pharmaceuticals has successfully completed recruitment for its pivotal Co-PSMA Phase II trial, testing its novel Cu-SAR-bisPSMA diagnostic against the current standard in detecting prostate cancer recurrence. This milestone advances their mission to improve early detection and treatment outcomes for men with low PSA levels.

Little Green Pharma reported a robust June 2025 quarter with record cash receipts and expanding European footprint, highlighted by a new production capacity in Denmark and the launch of its CherryCo brand in Germany.

Pacific Edge Limited has opened a $5 million Share Purchase Plan at $0.10 per share, conditional on shareholder approval of a prior $16.1 million Placement. The capital raise aims to extend the company’s cash runway and accelerate US market adoption of its bladder cancer diagnostic tests amid Medicare non-coverage.