Latest Medicare News

Pacific Edge Limited reported a resilient FY25 performance despite losing Medicare coverage for its Cxbladder tests in the US, announcing a $20 million equity raise to support commercialization and growth.

4DMedical has submitted its CT:VQ lung imaging technology for FDA clearance, aiming to disrupt the $1 billion US nuclear lung scan market with a non-nuclear, lower-cost alternative. Clinical studies show CT:VQ matches or exceeds existing nuclear imaging in accuracy and patient experience.

Lumos Diagnostics has secured Medicare reimbursement for its FebriDx test from a sixth Medicare Administrative Contractor, covering over 85% of US Medicare payment regions. This milestone advances the company’s commercialisation efforts in the US healthcare market.

EBR Systems has announced a fully underwritten A$55.9 million capital raise alongside a Security Purchase Plan to fund the commercial rollout of its FDA-approved WiSE CRT System, targeting a US$3.6 billion market opportunity in cardiac resynchronization therapy.

EBR Systems has raised A$55.9 million through a fully underwritten placement to fund the commercial rollout of its FDA-approved wireless cardiac pacing system, with plans for a limited market release in H2 2025 and expanded distribution in 2026.

Lumos Diagnostics has secured Medicare reimbursement for its FebriDx test from a fifth contractor, covering more than 70% of US Medicare payments and advancing its commercial reach.

Rhythm Biosciences’ subsidiary Genetype has landed a pivotal 12-month contract with the University of Melbourne to provide advanced breast cancer risk assessments, marking a significant step in personalised cancer screening.

EBR Systems has won FDA approval for its pioneering leadless WiSE CRT System, setting the stage for a phased US commercial rollout. The company also secured key Medicare reimbursement pathways and expanded manufacturing capacity, though financial sustainability remains a concern.

Tissue Repair Limited reports progress in its Phase 3 clinical trials for TR987® despite enrollment delays caused by US regulatory disruptions, while TR Pro+® sales hit record highs and manufacturing scale-up advances.

Pacific Edge’s Cxbladder Plus and Triage 1 diagnostic tests are set for significant Medicare reimbursement increases, potentially reshaping the company’s US market prospects.

Echo IQ Limited marked a pivotal quarter with FDA clearance for EchoSolv AS, strategic US partnerships, and a clear path toward reimbursement and broader commercialisation.

Vitasora Health Limited reports a striking 101% revenue increase and 57% patient growth in Q1 2025, driven by new Medicare Shared Savings Plan contracts and significant operational efficiencies from its Orb Health merger.