Latest Us Medicare News

Lumos Diagnostics reported a 74% increase in its half-year loss to US$4.88 million, despite strong progress with its FebriDx diagnostic test and a landmark US distribution agreement. The company awaits a critical FDA decision that could unlock significant revenue growth.

Aroa Biosurgery reaffirms strong FY26 guidance, buoyed by favourable US Medicare reimbursement for Symphony and promising trauma study results for Myriad.

Tissue Repair’s December quarter update reveals a cautious path forward for its Phase 3 TR987 trial amid slow patient recruitment, while its TR Pro+ product line gains momentum through a new distributor partnership and upcoming product launches.

Adherium Limited has exceeded its 2025 shipment goals for its Hailie Smartinhaler devices, driven by rapid growth in remote patient monitoring activations and improved US Medicare reimbursement policies.

PainChek has secured FDA De Novo clearance, enabling entry into the vast US healthcare market with a $3 billion Remote Therapeutic Monitoring opportunity. The company reports $5.6 million contracted ARR and a strong global footprint in aged care.

Epiminder Limited has successfully listed on the ASX, raising $125 million to commercialise its FDA-approved Minder device. The company has initiated the first US implant and secured five leading medical centres for its DETECT study.

Proteomics International Laboratories has clarified that no undisclosed information explains its recent share price jump, pointing instead to recent Medicare reimbursement decisions and key product developments.

Proteomics International secures a key Medicare reimbursement rate for its PromarkerD test, a predictive diagnostic for diabetic kidney disease, marking a critical step in its US commercial rollout.

Aroa Biosurgery reported a 14% rise in product sales to NZ$44.6 million for the half-year ended September 2025, driven by strong growth in its Myriad portfolio. The company also posted a normalised EBITDA profit and reaffirmed its FY26 revenue and profit guidance.

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.

Nova Eye Medical reported a robust 32% increase in global sales excluding China for Q1 FY26 and secured regulatory approval for its iTrack™ Advance device in China, setting the stage for expanded market penetration.

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.