The clearance puts the non-contrast ventilation-perfusion imaging product on the Australian Register of Therapeutic Goods, allowing commercial rollout using routine chest CT scans rather than nuclear medicine infrastructure.
4DMedical said its CT:VQ™ respiratory imaging software has received Therapeutic Goods Administration approval and been listed on the Australian Register of Therapeutic Goods, clearing the way for commercial deployment across Australia. The product generates ventilation-perfusion imaging (mapping airflow and blood flow in the lungs) and regional functional lung data from routine, non-contrast chest CT scans, without injected contrast agents, radiotracers, or dedicated nuclear medicine equipment. The company said the software-based approach can expand access to functional lung assessment by using CT systems already installed across metropolitan, regional, and rural healthcare settings, while also helping hospitals preserve nuclear medicine capacity for other diagnostic and therapeutic services. Founder, Managing Director and CEO Andreas Fouras called the approval an important milestone for respiratory diagnostics in 4DMedical's home market. The company added that CT:VQ™ has held FDA clearance since 2025 and has been deployed at Stanford, Cleveland Clinic, UC San Diego Health, University of Chicago Medicine, University of Miami, and SimonMed. It also said the product holds regulatory clearance in Australia, the United States, European Union, United Kingdom, Canada, and New Zealand.