Latest Medicare News

Pacific Edge Limited has launched a NZ$20 million capital raise to bolster its cash reserves amid the loss of Medicare coverage for its bladder cancer diagnostic tests, aiming to accelerate US market adoption and support new product development.

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.