Latest Reimbursement Policy News

Cyclopharm Limited is accelerating its US market push for Technegas with a A$16 million capital raise following a record 2025 sales performance. The company aims to expand its US installations and advance new clinical applications beyond pulmonary embolism.

Aroa Biosurgery’s latest business update reveals promising clinical outcomes from its Myriad trauma study and evolving reimbursement policies that could reshape its market position. The company also projects solid revenue growth for FY26, supported by strategic commercial initiatives.

Adherium Limited has exceeded its 2025 shipment goals for its Hailie Smartinhaler devices, driven by rapid growth in remote patient monitoring activations and improved US Medicare reimbursement policies.

Vitasora Health Limited reported a significant 22% increase in daily clinical billing productivity for the December 2025 quarter, alongside a 17% rise in operating revenue. With new CMS reimbursement policies now in effect, the company anticipates a further 10–20% revenue uplift in 2026.

Pacific Edge reports a 13.4% decline in test volumes for Q3 2026 but gains strategic momentum with a key Medicare advisory meeting and clinical endorsements poised to influence reimbursement policy.

Lumos Diagnostics has achieved a major milestone by securing 100% Medicare reimbursement recognition for its FebriDx test across all seven US Medicare Administrative Contractors, paving the way for broader adoption in the American healthcare system.

EBR Systems has achieved a major commercial milestone with Medicare reimbursement approvals for its wireless cardiac pacing WiSE CRT System, driving a 201% revenue increase in Q3 2025. The company is advancing its Limited Market Release as it scales adoption in the US.

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.

Medicare contractor Novitas plans to convene an expert panel in early 2026 to review coverage for Pacific Edge’s Cxbladder Triage test following the 2025 update to the American Urological Association microhematuria guideline.

PolyNovo’s NovoSorb BTM, combined with negative pressure wound therapy, significantly accelerates healing of large post-surgical diabetic foot wounds, according to new clinical trial data.

Clinuvel Pharmaceuticals has reported a robust financial year ending June 2025, marked by solid revenue growth and sustained profitability, while advancing its clinical pipeline and maintaining a strong balance sheet.

CurveBeam AI Limited posted a strong 85% increase in revenue to $12.1 million for FY25, alongside a reduced net loss of $16.8 million. Despite operational improvements and a recent $11.58 million capital raise, the company flags material uncertainty over its ability to continue as a going concern.