MELBOURNE, Australia, June 29, 2026
4DMedical has achieved a major regulatory milestone with the Therapeutic Goods Administration (TGA) approving its CT™ functional lung imaging technology and including the solution on the Australian Register of Therapeutic Goods (ARTG). The approval enables the commercial rollout of CT™ across Australia, introducing the country’s first and only non-contrast, CT-based ventilation-perfusion (V/Q) imaging solution capable of generating detailed regional lung function information directly from routine chest CT scans. The breakthrough technology represents a significant advancement in respiratory imaging by eliminating the need for injected contrast agents, radioactive tracers, specialized nuclear medicine cameras, or dedicated imaging infrastructure traditionally required for ventilation-perfusion studies. By leveraging existing CT imaging systems already available in hospitals and diagnostic imaging centers, CT™ expands access to advanced functional lung assessment while supporting faster clinical decision-making for patients with respiratory diseases across metropolitan, regional, and rural healthcare environments.
Advanced Functional Lung Imaging Without Contrast or Nuclear Medicine
Unlike conventional ventilation-perfusion (V/Q) imaging, which relies on radiotracers, dedicated nuclear medicine equipment, and specialized clinical workflows, CT™ utilizes standard chest CT scans to generate comprehensive regional ventilation and perfusion maps without additional invasive procedures. The technology provides physicians with valuable functional information regarding airflow and blood flow throughout the lungs while reducing dependence on limited nuclear medicine resources. By integrating advanced image processing with existing CT infrastructure, hospitals can perform functional lung assessments more efficiently while maintaining streamlined clinical workflows.
The technology offers important advantages for radiologists, respiratory physicians, pulmonologists, cardiothoracic surgeons, emergency physicians, and healthcare providers managing patients with complex pulmonary disorders. CT™ also enables healthcare facilities to preserve nuclear medicine capacity for other high-priority diagnostic and therapeutic procedures, supporting more efficient resource utilization while improving access to advanced respiratory imaging services throughout Australia’s healthcare system.
Global Adoption Strengthens 4DMedical’s Respiratory Imaging Leadership
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The Australian regulatory approval builds upon 4DMedical’s growing international presence, with CT™ already deployed at several leading healthcare institutions in the United States, including Stanford, Cleveland Clinic, UC San Diego Health, University of Chicago Medicine, University of Miami, and SimonMed. The successful introduction into the Australian market further strengthens the company’s position as a global innovator in functional lung imaging and respiratory diagnostics. By providing detailed regional lung function information directly from routine CT examinations, the platform supports more accurate evaluation of pulmonary diseases while offering clinicians additional insights for treatment planning and patient management. The technology has the potential to benefit patients undergoing assessment for a broad range of respiratory and cardiopulmonary conditions where understanding both ventilation and perfusion is clinically important.
The TGA approval represents a significant advancement in medical imaging innovation, demonstrating how software-enabled imaging technologies can transform existing diagnostic workflows without requiring costly new equipment or complex infrastructure investments. As demand continues to grow for accessible, high-quality respiratory diagnostics, 4DMedical’s CT™ platform is positioned to redefine functional lung imaging by delivering scalable, non-invasive, and efficient clinical solutions that enhance diagnostic confidence while improving healthcare accessibility across Australia and supporting the future evolution of precision respiratory medicine.
Source: 4DMedical press release
