Latest Reimbursement Coverage News

ImpediMed has secured FDA 510(k) clearance for its SOZO Digital Health Platform to assess sarcopenia risk, marking it as the only FDA-cleared bioimpedance spectroscopy solution for this clinical application. This clearance enables clinicians to non-invasively monitor muscle loss in cancer and chronic disease patients, potentially improving treatment outcomes.

ImpediMed reported a 3% revenue increase to $3.6 million in Q4 FY26, bolstered by a $15.3 million capital raise and strategic leadership hires as it pushes growth in cancer survivorship, heart health, and weight management.

ImpediMed has secured A$15.2 million through a two-tranche placement and share purchase plan, alongside A$5 million in cost reductions, aiming for operating cashflow breakeven by H2 FY28.

ImpediMed reported a $3.5 million revenue in Q3 FY26, with reimbursement coverage in the US reaching 94.3%, supporting growth in heart health and weight management markets. New CEO Erik Anderson aims to accelerate commercial momentum and drive cash flow break-even.

Imricor Medical Systems updates its SEC Form 10 with minor SEC-driven revisions as it pushes forward with FDA clearances and clinical trials, reporting a $25.3 million net loss in 2025 amid early-stage commercialisation.

ImpediMed Limited has appointed Erik Anderson as its new CEO and Managing Director, effective 7 April 2026, aiming to boost commercial execution and revenue growth in the US market. Dr Parmjot Bains will remain as an advisor until 30 June 2026 to ensure a smooth leadership transition.

Lumos Diagnostics reported a strong surge in FebriDx® sales alongside positive FDA feedback, securing full Medicare reimbursement and advancing key clinical studies.

ImpediMed reported a solid Q2 FY26 with $3.9 million in revenue and significant reimbursement gains for its lymphoedema technology, while launching new US Heart Health and Wellness initiatives.

Lumos Diagnostics has achieved a major milestone by securing 100% Medicare reimbursement recognition for its FebriDx test across all seven US Medicare Administrative Contractors, paving the way for broader adoption in the American healthcare system.

Control Bionics reports a strong start to FY26 with nearly 10% revenue growth, expanded US reimbursement coverage, and advancing commercialization of its NeuroNode and NeuroStrip technologies.

ImpediMed Limited reported a record A$3.6 million quarterly revenue and expanded its US hospital footprint with over 600 SOZO units installed. The launch of SOZO Pro targets new heart failure markets, while reimbursement coverage accelerates across US states.

Lumos Diagnostics reported steady quarterly revenue with a 300% surge in product sales, driven by its flagship FebriDx® test. The company inked a landmark US$317 million exclusive U.S. distribution agreement and awaits FDA feedback on its CLIA waiver application.