#Australia #Melbourne #4DMedical #CTVQ #Lung Imaging

4DMedical's Advanced Breathing Diagnostics Revolutionized in Australia

4DMedical Limited (ASX: 4DX), a pioneer in advanced lung imaging, recently celebrated a significant milestone by receiving regulatory approval from the Therapeutic Goods Administration (TGA) for its groundbreaking technology, CTVQ™. This approval now allows the commercial deployment of CTVQ™ across Australia, marking a turning point in lung diagnostics.

CTVQ™ represents a state-of-the-art imaging solution that extracts vital ventilation and perfusion data from routine contrast-free chest CT scans. It offers healthcare professionals detailed insights into lung function without the need for injected contrast agents or specialized nuclear medicine infrastructure. The ability to harness existing CT imaging resources enhances the scalability and accessibility of functional lung assessments.

Significance of the TGA Approval

The impact of TGA's approval cannot be overstated. According to Andreas Fouras, the founder and Managing Director of 4DMedical, this achievement is a vital step forward for respiratory diagnostics in their home market. As the first and only contrast-free, CT-based imaging solution for ventilation and perfusion, CTVQ™ is set to provide healthcare practitioners with crucial insights into lung functionality, utilizing the pre-existing infrastructure in the Australian healthcare system.

Australia's high density of CT scanners makes it a promising market for widespread implementation of CTVQ™, providing new avenues for lung diagnostics that were previously limited by the need for complex nuclear medical processes. Typically, performing ventilation and perfusion imaging requires specific nuclear medicine devices and radiotracers, which can pose significant barriers to accessibility. CTVQ™, in contrast, leverages existing CT infrastructure, simplifying the process and allowing a broader range of healthcare facilities to perform these important assessments.

Tailoring to Healthcare Needs

Amid rising demands for scalable and cost-effective diagnostic technologies, CTVQ™ is particularly valuable in the context of urban, regional, and rural healthcare settings across Australia. It holds immense potential for facilities that do not possess onsite nuclear medicine capabilities, thereby allowing hospitals and imaging centers to maintain nuclear medicine resources for other essential diagnostic and therapeutic purposes.

Following its FDA approval in 2025, CTVQ™ has already been integrated into leading healthcare institutions in the United States, including Stanford, the Cleveland Clinic, UC San Diego Health, and University of Chicago Medicine, among others. The successful adoption at these prestigious institutions demonstrates the technology's reliability and potential benefits in clinical settings.

4DMedical's Vision for Enhanced Healthcare

4DMedical is positioned as a global medical technology company striving to revolutionize respiratory care through advanced imaging and artificial intelligence. The patented XV Technology® transforms conventional scans into actionable insights, empowering healthcare providers to detect, diagnose, and monitor lung disorders with unprecedented precision.

The company's expanding software portfolio includes FDA-cleared solutions like the XV Lung Ventilation Analysis Software (XV LVAS®) and CT LVAS™, as well as the cutting-edge CTVQ™ that integrates ventilation and perfusion analysis, setting new standards in cardiothoracic imaging.

With its software-as-a-service (SaaS) delivery model, 4DMedical seamlessly integrates its solutions into existing hospital infrastructures, enhances physician productivity, and facilitates more personalized patient care. Furthermore, the incorporation of advanced AI capabilities through the acquisitions of Imbio in 2023 and contextflow in 2026 continues to push the boundaries of medical imaging, aiming to redefine the understanding and treatment of respiratory diseases globally.

CTVQ™: A Game-Changer in Diagnostic Imaging

What is CTVQ™?

CTVQ™ stands for a contrast-free ventilation-perfusion imaging solution, allowing for the derivation of regional lung function information from standard chest CT scans.

How does CTVQ™ differ from traditional V/Q scans?

Unlike conventional nuclear medicine techniques for ventilation and perfusion imaging, CTVQ™ does not require radiotracers, injected contrast, specialized cameras, or dedicated nuclear medicine infrastructure. It utilizes scans from existing CT imaging resources to generate functional lung information.

Is contrast or radioactive substances required for CTVQ™?

No, CTVQ™ operates without contrast agents, eliminating the need for any injected or inhaled radiotracers or radioactive isotopes.

Why is TGA approval important?

The TGA's endorsement enables CTVQ™'s commercial use throughout Australia, promoting broader access to functional lung imaging by utilizing the existing CT technologies available in healthcare facilities nationwide.

Where is CTVQ™ approved and used?

CTVQ™ has received regulatory approval in Australia, the United States, the European Union, the United Kingdom, Canada, and New Zealand. It is already in use in several leading healthcare systems in the United States, enhancing the diagnostic landscape significantly.