4DMedical Secures US$650 Medicare Reimbursement for CT:VQ™, Boosting Revenue Potential

A Regulatory Breakthrough for Lung Imaging

4DMedical Limited has marked a pivotal moment in respiratory diagnostics with the FDA’s clearance of CT – VQ™, the world’s first non-contrast, CT-based ventilation-perfusion imaging technology. This innovation allows clinicians to assess lung function comprehensively without radioactive tracers or contrast agents, leveraging routine CT scans instead. The clearance not only validates years of scientific development but also opens the door to transforming lung health assessment globally.

Crucially, the U.S. Centers for Medicare & Medicaid Services (CMS) swiftly followed with reimbursement approval at US$650.50 per scan, effective immediately. This reimbursement is in addition to standard chest CT fees, removing a significant barrier to adoption and providing hospitals and imaging centres with financial certainty to integrate CT – VQ™ into clinical workflows.

Rapid Commercial Adoption and Strategic Partnerships

Less than two months post-clearance, Stanford University has become the first U.S. Academic Medical Centre to adopt CT – VQ™ commercially, underscoring the technology’s clinical promise. This adoption is part of a broader rollout strategy targeting key opinion leader sites to drive clinical validation and physician education, essential steps for widespread market penetration.

Internationally, 4DMedical expanded its partnership with AstraZeneca in Brazil, growing the Lung Health Screening Program to six hospitals capable of performing approximately 48,000 CT scans annually. This program focuses on lung cancer screening and incidental detection of conditions like coronary artery calcification and COPD, positioning 4DMedical at the forefront of preventative respiratory care in emerging markets.

In Australia, the company secured key contracts supporting the National Lung Cancer Screening Program, including a pilot agreement with Royal Melbourne Hospital to deploy its full suite of respiratory imaging products. Spectrum Medical Imaging also extended its multi-year agreement, enhancing its technology stack to support lung health initiatives nationwide.

Scientific Validation and Financial Strength

Adding to its clinical credentials, 4DMedical published a major study in the American Journal of Respiratory and Critical Care Medicine demonstrating that its XV LVAS® technology accurately predicts pneumothorax risk in COPD patients undergoing bronchoscopic lung volume reduction. This insight could significantly improve patient outcomes by enabling risk stratification before treatment.

Financially, the company reported operating revenue of $1.4 million for Q1 FY26 with gross margins exceeding 90%. Operating cash outflows improved by $0.5 million quarter-on-quarter, supported by a strong cash balance of $33.5 million. Additionally, there is potential for a further $30.2 million in capital inflows from outstanding options, providing a robust runway for ongoing commercialisation efforts.

Global SaaS deployment continues to accelerate, with 4DMedical’s products now delivered at 409 sites worldwide; a 50.9% increase year-on-year; and over 74,000 scans performed in the quarter, more than doubling compared to the previous year.

Looking Ahead

With CT – VQ™ poised to disrupt traditional nuclear ventilation-perfusion imaging, 4DMedical is entering FY2026 with strong momentum. The company’s strategic partnerships, expanding clinical footprint, and solid financial foundation set the stage for further growth and innovation in respiratory care. The upcoming RSNA 2025 conference will be a key platform to showcase CT – VQ™ and advance its global adoption.