4DMedical Gains TGA Approval for CT:VQ Lung Imaging in Australia

The approval marks a shift in how respiratory diagnostics are delivered, moving away from traditional radiotracers and injected contrast agents. By leveraging standard CT scanners, the technology aims to broaden access to functional lung assessments in metropolitan and rural clinics alike. According to Andreas Fouras, founder and CEO of 4DMedical, the high density of CT scanners throughout Australia makes the region a primary candidate for widespread implementation of the software.

Beyond technical efficiency, the tool offers a way to preserve nuclear medicine capacity. Facilities that lack dedicated services can now perform functional lung imaging, while larger hospitals can reserve their nuclear medicine departments for complex therapeutic procedures. Since its initial FDA clearance in 2025, the platform has been adopted by major U.S. institutions, including Stanford, the Cleveland Clinic, and UC San Diego Health. The addition of the Australian market follows similar regulatory successes in the United States, the European Union, the United Kingdom, Canada, and New Zealand.