Latest Us Market Access News

Pharmaceutical manufacturer ANO has been hit with a US FDA Import Alert, joining several Australian peers amid wider regulatory tensions. The company is mobilising expert consultants and preparing a petition to lift the alert within weeks.

ECS Botanics is strategically preparing for entry into the US medicinal cannabis market, leveraging its EU-GMP certification and proprietary genetics amid evolving regulatory landscapes.

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.

4DMedical Limited has secured FDA clearance and immediate Medicare reimbursement for its groundbreaking CT – VQ™ lung imaging technology, accelerating commercial adoption across the US, Brazil, and Australia.

Polynovo Limited reported a robust 23.3% increase in total revenue for FY25, driven by strong commercial sales growth across the US and international markets. The company is advancing its FDA PMA submission and expanding its global footprint amid strategic product development.

Proteomics International has secured a dedicated US reimbursement code for its next-generation PromarkerD test, a key step towards broader adoption in diabetic kidney disease diagnostics.

Lumos Diagnostics has enrolled 500 patients in its FebriDx CLIA waiver clinical study, unlocking a significant milestone payment from BARDA and moving closer to FDA approval that could open a US$1 billion market.

Bubs Australia has submitted critical clinical trial data to the US FDA, marking a pivotal step toward permanent approval for its infant formulas in the US market.

Lumos Diagnostics has secured Medicare reimbursement for its FebriDx test from a sixth Medicare Administrative Contractor, covering over 85% of US Medicare payment regions. This milestone advances the company’s commercialisation efforts in the US healthcare market.

NoviqTech has advanced its blockchain-based sustainability solutions, pioneering real-world asset tokenisation and expanding its investor base through OTCQB trading in the US.

Pacific Edge’s Cxbladder Plus and Triage 1 diagnostic tests are set for significant Medicare reimbursement increases, potentially reshaping the company’s US market prospects.