4DMedical Receives TGA Approval for CT:VQ™, Bringing Non-Contrast Ventilation-Perfusion Imaging to Australia

Non-contrast, ventilation-perfusion imaging—from routine chest CT scans

MELBOURNE, Australia, June 29, 2026 /PRNewswire/ -- 4DMedical Limited (ASX: 4DX), the global leader in advanced respiratory imaging, today announced that CT:VQ™ technology has Therapeutic Goods Administration (TGA) approval and is included on the Australian Register of Therapeutic Goods (ARTG)—enabling commercial deployment across Australia.

CT:VQ™ gives physicians access to ventilation and perfusion imaging and data derived directly from routine, non-contrast, chest CT scans. CT:VQ™ delivers regional functional lung information without the use of injected contrast agents, radiotracers, or dedicated nuclear medicine infrastructure.

"TGA approval marks an important milestone for respiratory diagnostics in our home market," said Andreas Fouras, Founder, Managing Director and CEO of 4DMedical.

"As the first and only, non-contrast, CT-based ventilation-perfusion imaging solution, CT:VQ™ gives healthcare providers detailed, functional lung information using infrastructure already available throughout the healthcare system. Plus, Australia's high CT scanner density makes an attractive market for broad implementation."

Ventilation-perfusion imaging typically requires dedicated nuclear medicine equipment, radiotracers, and specialized operational workflows. But CT:VQ™ provides a software-based alternative that integrates off scans performed from existing CT imaging infrastructure—potentially expanding access to functional lung assessment across a broader range of healthcare settings.

CT:VQ™ approval comes as healthcare systems increasingly seek scalable and affordable technologies that expand diagnostic capabilities by leveraging existing imaging resources. Using standard CT infrastructure already available across Australia, CT:VQ™ can broaden access to functional lung imaging in metropolitan, regional, and rural settings. CT:VQ™ can be particularly valuable for both facilities that lack onsite nuclear medicine services, and for hospitals and imaging centres that do, by helping preserve nuclear medicine capacity for their other diagnostic and therapeutic services.

Since receiving FDA clearance in 2025, CT:VQ™ has been deployed at leading U.S. institutions including Stanford, Cleveland Clinic, UC San Diego Health, University of Chicago Medicine, University of Miami, and SimonMed, one of the largest private outpatient radiology networks in the United States.

About 4DMedical

4DMedical Limited (ASX:4DX) is a global medical technology company revolutionising respiratory care with advanced imaging and artificial intelligence. Its patented XV Technology® transforms standard scans into rich, functional insights that allow physicians to detect, diagnose, and monitor lung disease earlier and with greater precision.

4DMedical's expanding software portfolio includes the FDA-cleared XV Lung Ventilation Analysis Software (XV LVAS®), CT LVAS™, and the ground-breaking CT:VQ™ solution designed to set new benchmarks in cardiothoracic imaging by combining ventilation and perfusion analysis.

Delivered seamlessly through a Software-as-a-Service (SaaS) model, 4DMedical's solutions integrate into existing hospital infrastructure, enhancing physician productivity and enabling more personalised patient care. With the addition of advanced AI capabilities from its 2023 acquisition of Imbio and 2026 acquisition of contextflow, 4DMedical continues to push the boundaries of medical imaging to redefine how respiratory disease is understood and treated worldwide.

Frequently Asked Questions

What is CT:VQ™?

CT:VQ™ is a non-contrast ventilation-perfusion imaging solution that derives regional lung function information from routine chest CT scans.

How does CT:VQ™ differ from a traditional V/Q scan?

Unlike conventional nuclear medicine ventilation-perfusion imaging, CT:VQ™ does not require radiotracers, injected contrast agents, specialized cameras, or dedicated nuclear medicine infrastructure. It uses scans produced from existing CT imaging resources to generate functional lung information.

Does CT:VQ™ require contrast agents or radioactive materials?

No. CT:VQ™ is a non-contrast imaging solution that does not require injected contrast agents, inhaled radiotracers, or radioactive isotopes.

Why is TGA approval important?

TGA approval allows CT:VQ™ to be commercially deployed across Australia and supports wider access to functional lung imaging using existing CT infrastructure already available in healthcare facilities nationwide.

Where is CT:VQ™ approved and in use?

CT:VQ™ holds regulatory clearance in Australia, the United States, European Union, United Kingdom, Canada, and New Zealand. It has been deployed at leading U.S. health systems including Stanford, Cleveland Clinic, UC San Diego Health, University of Chicago Medicine, University of Miami, and SimonMed, one of the largest private outpatient radiology networks in the United States.

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SOURCE 4DMedical