Latest Medicare Reimbursement News

Epiminder has ramped up enrolment in its DETECT study, contracting 18 US medical centres and maintaining a robust $83.8 million cash position to fund its Minder device commercialisation through 2028.

Anteris Technologies has gained U.S. Medicare reimbursement eligibility for its pivotal PARADIGM Trial, clearing a key hurdle for clinical site activation and accelerating its transcatheter heart valve study.

BCAL Diagnostics has expanded its Avantect cancer blood tests nationally through major pathology networks, generating $88,000 in Q3 revenue from 91 tests. The company also submitted an initial Medicare reimbursement application for pancreatic cancer detection and is preparing to launch an enhanced BREASTESTplus 2.0 test in early 2027.

Pacific Edge reported a 2.7% increase in test volumes for Q4 2026 despite operational challenges, supported by growing momentum toward Medicare coverage and expanded commercial payer adoption in the US and Asia Pacific.

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.