Latest Medicare News

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.

Neuren Pharmaceuticals reports a robust 11% rise in DAYBUE™ US net sales for Q1 2025, alongside a 17% jump in royalty income, setting the stage for an anticipated European market entry in early 2026.

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.

Lumos Diagnostics reported a 21% quarter-on-quarter revenue increase in Q3 FY25, driven by strong product sales and expanded development agreements. The company also secured Medicare coverage in key US regions and advanced its pivotal FebriDx CLIA waiver study with FDA submission expected by year-end.

Nova Eye Medical Limited is raising A$6.6 million to strengthen its financial position following resolved supply chain disruptions, while reporting strong sales growth and nearing profitability in its glaucoma division.

Nova Eye Medical reports a robust 39% increase in global sales driven by strong U.S. market demand and secures $6.6 million in fresh capital to fuel expansion and product development.

Opthea Limited has spotlighted Sozinibercept as a potential game-changer in wet age-related macular degeneration (AMD) therapy, presenting compelling clinical data and a clear path to U.S. market entry.

Pacific Edge announces a two-month delay in the Medicare Local Coverage Determination for its genetic oncology tests, extending the effective date to April 24, 2025. This extension follows the company’s active engagement with US regulatory bodies.

Respiri Limited reports a standout December quarter marked by a 67% surge in patient program enrolments and robust revenue growth, bolstered by strategic acquisition synergies from Orb Health. The company is poised for further expansion in 2025 amid promising contract negotiations and evolving US healthcare reimbursement policies.