Latest Medicare News

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.

Mesoblast Limited reports a robust 66% increase in Ryoncil revenues for Q2 2025, driven by strong market adoption and new Medicare reimbursement codes.

Telix Pharmaceuticals secures Transitional Pass-Through payment status for its next-generation prostate cancer imaging agent Gozellix, paving the way for broader US patient access and streamlined provider reimbursement.

EBR Systems has secured final CMS approval for Transitional Pass-Through reimbursement for its WiSE CRT System, effective October 1, 2025, enhancing hospital adoption prospects in the U.S.

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.

The US Centers for Medicare & Medicaid Services has recommended a final reimbursement price of US$1,328 for Pacific Edge’s advanced bladder cancer diagnostic test, Cxbladder Triage Plus, marking a significant increase from earlier proposals.

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.

PolyNovo Limited stands to benefit from proposed U.S. Medicare changes that introduce a flat reimbursement rate for outpatient wound care skin substitutes, potentially reshaping the competitive landscape in favour of cost-effective, clinically proven products.

Tissue Repair Ltd reported a 27.3% revenue increase to $3.22 million for FY25, driven by new distribution deals and regulatory progress, while continuing to invest heavily in clinical trials and manufacturing scale-up, resulting in a $4.24 million loss.

Cyclopharm Limited reported a 26% revenue increase for the half year ended June 2025, driven by rapid US market expansion and strong growth in its Third-Party distribution business. Despite a wider net loss, the company secured a key patent extension and reaffirmed its target to install 250-300 Technegas® systems in the US by late 2026.

Integral Diagnostics (IDX) reported a robust FY25 with 33.7% revenue growth and operating EBITDA margin expansion, driven by the Capitol merger and organic growth. The company exceeded synergy expectations and outlined a confident outlook amid favourable industry tailwinds.