4DMedical Receives TGA Approval for Non-Contrast Ventilation-Perfusion Imaging

Australia becomes the latest market to grant regulatory approval for 4DMedical’s CTVQ (Image Credit: PRNewswire)
Australia becomes the latest market to grant regulatory approval for 4DMedical’s CTVQ (Image Credit: PRNewswire)

4DMedical Limited (ASX: 4DX), one of the global leaders in advanced respiratory imaging, recently 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.

(Image Credit: PRNewswire)
(Image Credit: PRNewswire)

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.

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