Latest Medicare News

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.

Telix Pharmaceuticals reports a robust 53% revenue jump in Q3 2025 and raises its full-year guidance, underpinned by key reimbursement wins and expanding clinical programs.

Pacific Edge reports a 9% decline in Cxbladder test volumes amid Medicare coverage loss but gains momentum with new clinical validation and a CMS pricing boost.

INOVIQ Limited has launched an A$11.5 million capital raise to fast-track clinical validation and commercialization of its ovarian cancer screening test and advance its CAR-exosome therapeutic program targeting solid tumors.

INOVIQ Limited has raised $11.5 million through a $9.5 million placement and a $2 million share purchase plan to accelerate the development and commercialisation of its EXO-OC ovarian cancer test and exosome therapeutic program.

PainChek Limited has secured its first US customer, Jewish Home Family, just days after receiving FDA De Novo clearance for its AI-powered pain assessment app, marking a significant step into the $100 million US aged care market.

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.