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4DMedical's CTVQ™ Technology Achieves TGA Approval in Australia

In a significant advancement for respiratory imaging, 4DMedical Limited (ASX: 4DX), the leader in this specialized field, has announced that its CT:VQ™ technology has received approval from the Therapeutic Goods Administration (TGA) in Australia. This milestone opens doors for the deployment of an innovative non-contrast ventilation-perfusion imaging solution throughout the country.

What is CTVQ™?

CTVQ™ stands for Computed Tomography Ventilation-Perfusion Quantification, a technology that provides physicians with essential data regarding lung function using standard chest CT scans. What distinguishes CTVQ™ from traditional imaging methods is its capability to derive detailed regional lung information without the need for injected contrast agents or radiotracers, which are typically required in conventional methods. This is particularly beneficial as it enhances the accessibility of lung assessments across various healthcare settings, from metropolitan hospitals to rural health centers.

The Implications of TGA Approval

With TGA's endorsement, CTVQ™ is now included on the Australian Register of Therapeutic Goods (ARTG), allowing for commercial deployment. Andreas Fouras, the Founder, Managing Director, and CEO of 4DMedical, expressed that this approval is a major milestone for respiratory diagnostics in Australia. He highlighted that Australia, with its high density of CT scanners, presents an attractive market for implementing this technology widely.

Traditionally, ventilation-perfusion imaging demanded specialized equipment and complex operational workflows, limiting its availability. CTVQ™ simplifies this process through a software-based solution that leverages existing CT imaging infrastructure, thus broadening the reach of functional lung assessments. This technology not only enhances diagnostic capabilities but also preserves resources in nuclear medicine for other essential diagnostic services.

Addressing the Needs of Modern Healthcare

In the context of increasing demands for scalable and affordable healthcare solutions, the introduction of CTVQ™ arrives at a pivotal moment. Hospitals and imaging centers, regardless of their existing nuclear medicine capabilities, can now offer comprehensive lung imaging without expensive upgrades or additional infrastructure. By utilizing the already established CT equipment, the technology significantly expands access to essential diagnostic services, particularly in facilities that may lack nuclear medicine services.

Global Recognition and Deployment

The U.S. is already experiencing the benefits of CTVQ™, having been recently implemented in prestigious institutions like Stanford and the Cleveland Clinic, highlighting its effectiveness and acceptance in leading healthcare systems. Since securing FDA clearance in 2025, this technology has gained accolades and interest globally. With TGA approval, Australia joined other regions that recognize and validate the potential of CTVQ™ including the European Union, the United Kingdom, Canada, and New Zealand.

Moreover, the innovative nature of 4DMedical transcends mere imaging solutions. By integrating advanced artificial intelligence capabilities, 4DMedical aims to redefine the landscape of respiratory care. Their expanding portfolio includes the FDA-cleared XV Lung Ventilation Analysis Software (XV LVAS®) and other advanced tools that provide physicians with crucial insights for diagnosing and monitoring lung diseases promptly and accurately.

Conclusion

4DMedical's CT:VQ™ technology, now approved by TGA, embodies the future of respiratory diagnostics by making non-contrast imaging accessible across Australia. Not only does it empower healthcare providers with vital information regarding lung function, but it also does so in a cost-effective manner that maximizes existing resources. As this technology rolls out, it is set to transform the way lung diseases are diagnosed and monitored, ultimately benefiting patients nationwide.