Latest Medicare Reimbursement 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.

Cyclopharm Limited reported a 17% revenue increase to a record $32.3 million in 2025, powered by a 226% surge in US Technegas sales. The company is accelerating its US rollout with plans for up to 300 installations in 2026, while advancing clinical trials beyond pulmonary embolism.

Epiminder Limited has reported a $21.7 million loss for the half-year ending December 2025, alongside a successful $125 million IPO that fuels its commercialisation of the FDA-approved Minder epilepsy monitoring device.

AVITA Medical reported a mixed fourth quarter with revenue pressures easing and full-year growth, underpinned by a new $60 million credit facility and advancing clinical trials.

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

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.

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

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.

Pacific Edge reports a 13.4% decline in test volumes for Q3 2026 but gains strategic momentum with a key Medicare advisory meeting and clinical endorsements poised to influence reimbursement policy.

Pacific Edge appoints Simon Flood as chairman designate, aiming to leverage his global investment expertise to navigate Medicare reimbursement challenges for its bladder cancer diagnostic tests in the US.

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.