Latest Medicare News

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.

INOVIQ Limited has completed a $10.2 million capital raise to accelerate development of its exosome-based ovarian cancer screening test and CAR-exosome therapeutics, alongside key leadership appointments and promising preclinical results.

PainChek has secured FDA-regulated medical device status, enabling US Remote Therapeutic Monitoring reimbursement and opening a major US growth avenue. The company targets musculoskeletal pain management in non-verbal dementia patients, a largely underserved market.

Vitasora Health Limited reported a significant 22% increase in daily clinical billing productivity for the December 2025 quarter, alongside a 17% rise in operating revenue. With new CMS reimbursement policies now in effect, the company anticipates a further 10–20% revenue uplift in 2026.

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.

Telix Pharmaceuticals has met its upgraded FY 2025 revenue guidance with US$804 million, driven by strong growth in its Precision Medicine segment and the successful US launch of Gozellix. The company also advanced multiple clinical trials and announced a strategic collaboration with Varian to combine radiopharmaceuticals with radiation therapy.

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.

PolyNovo reports a robust 26% increase in group sales for 1H FY26, driven by strong U.S. market expansion and a near tripling of NovoSorb MTX sales. The company also completes a new manufacturing facility, positioning itself for sustained growth.

Vitasora Health has completed an A$11 million capital raise, including a cornerstone investment, bolstering its balance sheet to support ambitious growth in the US healthcare market. The company targets cash flow breakeven by the end of FY2026 amid expanding patient programs and new partnerships.

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.