Latest Patient Safety News

Monash IVF Group reported solid FY25 revenue and EBITDA growth despite sector softness and clinical incidents, while announcing a leadership transition and dividend pause.

HeraMED has achieved a significant regulatory milestone with the Therapeutic Goods Administration upgrading its HeraBEAT fetal heart rate monitor to Class IIb, making it the only remote home-use device approved in Australia. This positions the company for a potentially lucrative expansion in the Australian maternity care market.

Dimerix Limited’s ACTION3 Phase 3 trial for DMX-200 in FSGS kidney disease has passed its seventh Independent Data Monitoring Committee review with no safety concerns, reinforcing the drug’s promising safety profile.

Alcidion Group Limited has reported a record FY25 with strong revenue growth, major NHS contract wins, and expanded AI capabilities in its Miya Precision platform, setting the stage for global healthcare IT expansion.

Tryptamine Therapeutics has enrolled the first patient in its pioneering clinical trial testing TRP-8803, an IV-infused psilocin formulation, for Binge Eating Disorder. The study aims to evaluate safety and efficacy, potentially reshaping treatment options for millions.

4DMedical has won a crucial US Medicare reimbursement for its CT, VQ™ lung imaging software, paving the way for rapid adoption across American hospitals. This milestone follows FDA clearance and promises to transform lung diagnostics with safer, faster scans.

Race Oncology has activated its first clinical trial site in Hong Kong for the Phase 1 study of RC220 combined with doxorubicin in advanced solid tumours, marking a significant step in accelerating patient enrolment and broadening clinical data.

Mesoblast Limited has reported its FY2025 results, highlighting the FDA approval and US commercial launch of Ryoncil, its first mesenchymal stromal cell therapy, alongside a $102.1 million net loss and $161.6 million in cash reserves.

Clinuvel Pharmaceuticals reports steady financial growth with an 8% rise in revenue and 2% profit increase, while expanding its US commercial footprint and completing recruitment for a pivotal vitiligo trial.

Australian Clinical Labs reported a 6.4% revenue increase and an 8.7% rise in underlying EBIT for FY25, maintaining disciplined growth and operational efficiency in a complex healthcare environment.

Monash IVF Group reported a 5.6% rise in underlying EBITDA for FY25, navigating a declining Australian IVF market and operational challenges. The company sets a cautious FY26 NPAT guidance of $20-23 million while focusing on regaining market leadership and implementing safety reforms.

Monash IVF Group has completed an independent review into two separate clinic incidents involving non-standard IVF treatments, revealing human errors and IT system issues. The company commits to enhanced safeguards without expecting significant financial impact.