Latest Reimbursement News

Lumos Diagnostics has secured a pivotal US FDA CLIA waiver for its FebriDx® test, vastly expanding its market reach and triggering milestone payments that bolster its US commercial rollout.

Firebrick Pharma has secured its first regulatory approval for Nasodine Nasal Spray in Indonesia, paving the way for entry into Southeast Asia’s largest market. This milestone marks a significant step in the company’s international expansion strategy.

Nexsen Limited is advancing its rapid Group B Streptococcus test, StrepSure®, with a clear FDA submission timeline and early market entries across Asia-Pacific and emerging regions.

4DMedical’s advanced lung imaging technology CT:VQ™ has been deployed at the Mayo Clinic, marking the sixth top US academic medical centre to adopt the system within seven months of FDA clearance.

Emyria Limited is on track to open its first Empax clinic in Victoria by Q2 2026, having secured key operational milestones including a trained clinical workforce and dual reimbursement pathways.

Worley has received the Full Notice to Proceed from Venture Global for Phase 2 of the CP2 LNG export project in Louisiana, marking a significant milestone following Venture Global’s Final Investment Decision.

EBR Systems marked a pivotal transition in 2025 with FDA approval of its WiSE CRT System and the initiation of U.S. commercial implants, generating $1.6 million in revenue. Despite this progress, the company reported a net loss of $48.8 million and completed a significant capital raise to support ongoing growth.

Corazon Mining Limited has secured rights to apply for exploration licences covering 537 km² in the Plutonic Marymia Greenstone Belt, following a withdrawal agreement with IGO Limited that includes access to proprietary historical data.

IperionX Limited has denied any undisclosed information following a sharp share price drop from $6.93 to $4.58, clarifying its accounting for U.S. government grants amid market volatility.

Acrux Limited has secured a $0.55 million advance on its FY26 R&D Tax Incentive, providing crucial funding to accelerate development of its Hormone Replacement Therapy following FDA regulatory confirmation.

Adherium Limited reports a strong uptick in Remote Patient Monitoring revenue and device activations, driven by new reimbursement codes and strategic partnerships, aiming for 10,000 RPM patients by year-end.

Rhythm Biosciences has achieved a significant regulatory milestone with NATA accreditation for its ColoSTAT® blood-based colorectal cancer test, enabling its commercial rollout in Australia and strengthening reimbursement prospects.