4DMedical has cleared a major regulatory hurdle with the Therapeutic Goods Administration approving its CT:VQ™ lung imaging software, paving the way for commercial use across Australia and strengthening its global footprint.
- CT:VQ™ gains TGA approval and ARTG listing
- Australia joins US, EU, UK, Canada, New Zealand markets
- Software enables functional lung imaging without contrast agents
- Leverages Australia's high CT scanner density for broad access
- Preparing MSAC submission for Medicare reimbursement
TGA Approval Opens Australian Market
4DMedical (ASX:4DX) has secured Therapeutic Goods Administration (TGA) approval for its CT:VQ™ ventilation-perfusion imaging software, marking a pivotal moment for the company’s commercial ambitions in Australia. This regulatory green light, coupled with inclusion on the Australian Register of Therapeutic Goods (ARTG), authorises the deployment of CT:VQ™ across the country’s healthcare system.
The software offers a non-contrast, radiation-efficient method for assessing lung function by extracting ventilation and perfusion data from standard CT scans, sidestepping the need for injections, radiotracers, or nuclear medicine equipment. This positions CT:VQ™ as a disruptive alternative to traditional ventilation-perfusion imaging, particularly in settings lacking nuclear medicine infrastructure.
Building on Global Regulatory Momentum
Australia now joins a growing list of markets cleared for CT:VQ™, including the United States, European Union, United Kingdom, Canada, and New Zealand. Each new jurisdictional approval not only expands immediate commercial opportunities but also fortifies the clinical and regulatory foundation underpinning CT:VQ™’s global adoption.
4DMedical’s momentum in the United States has been especially notable since FDA clearance in September 2025, with deployments at leading academic medical centres such as Stanford, Cleveland Clinic, and University of Miami. The company’s recent commercial agreement with SimonMed Imaging, a major US outpatient radiology provider, further validates CT:VQ™’s suitability for high-volume community imaging environments and sets a precedent for Australian rollout.
Leveraging Australia’s CT Infrastructure for Broad Access
Australia’s exceptional CT scanner density, over 74 scanners per million people, ranking second globally, provides fertile ground for rapid adoption of CT:VQ™. This infrastructure advantage means the technology can reach regional and rural communities where nuclear medicine services are scarce or absent, as well as smaller hospitals and imaging centres without specialist nuclear medicine staff.
By deploying a software-only solution compatible with existing CT hardware, 4DMedical aims to reduce patient exposure to radioactive tracers and ease logistical burdens on health systems. This scalable approach could also free up nuclear imaging capacity for more complex procedures, including oncologic theranostics.
Pursuing Medicare Reimbursement to Boost Uptake
With TGA approval secured, 4DMedical is preparing a submission to the Medical Services Advisory Committee (MSAC) to seek inclusion of CT:VQ™ on the Medicare Benefits Schedule (MBS). This reimbursement pathway is critical for driving widespread clinical adoption and commercial viability in Australia.
The MSAC application will leverage clinical evidence, health-economic analyses, and real-world data from early Australian deployments. The company cites international regulatory validation and Australia’s extensive CT infrastructure as compelling factors supporting reimbursement consideration.
CEO Highlights Strategic Significance
Founder and MD Andreas Fouras described the TGA approval as a landmark for respiratory diagnostics in 4DMedical’s home market. He emphasised that each regulatory win contributes to the broader goal of establishing CT:VQ™ as the new global standard for functional lung assessment.
Fouras pointed to Australia’s scalability potential due to its CT infrastructure and highlighted ongoing US momentum, including deployments at top health systems and the SimonMed partnership. He framed 2026 as a defining year for expanding access to next-generation respiratory imaging worldwide.
Bottom Line?
The TGA approval unlocks Australia’s market for CT:VQ™, but the pace of clinical adoption will hinge on securing Medicare reimbursement and translating US commercial success locally.
Questions in the middle?
- How quickly will Australian hospitals and imaging centres integrate CT:VQ™ into routine practice?
- What timeline and hurdles lie ahead for MSAC approval and MBS listing?
- Can 4DMedical replicate its US commercial traction in Australia’s unique healthcare landscape?