Latest Medicare Reimbursement News

4DMedical Limited has secured FDA clearance and immediate Medicare reimbursement for its groundbreaking CT – VQ™ lung imaging technology, accelerating commercial adoption across the US, Brazil, and Australia.

Aroa Biosurgery delivered a robust September quarter with strong cash flow and record sales of its Myriad product, while reaffirming its FY26 revenue and EBITDA guidance. The company also highlighted a promising US Medicare reimbursement proposal for its Symphony product.

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

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.

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.

EBR Systems has secured FDA approval for its pioneering leadless WiSE CRT System and obtained key Medicare reimbursement endorsements, setting the stage for its commercial rollout. The company also completed a significant capital raise to support its market expansion.

AVITA Medical’s Q2 2025 update reveals a temporary setback in RECELL demand due to Medicare reimbursement delays, offset by strong revenue growth and promising clinical data. The company anticipates recovery and renewed growth in the second half of the year.

AVITA Medical reported a 21% increase in Q2 commercial revenue to $18.4 million and narrowed its net loss, yet faces a reimbursement hurdle that forced a downward revision of full-year guidance. The company highlights clinical progress and strategic board appointments as it navigates payment challenges.

EBR Systems has won final CMS approval for New Technology Add-On Payment reimbursement, paving the way for Medicare coverage of its innovative WiSE cardiac pacing system starting October 2025.