Aussie medtech secures TGA approval for advanced lung imaging technology

ASX-listed medtech company 4DMedical has secured Therapeutic Goods Administration (TGA) approval for its respiratory imaging technology, clearing the way for commercial deployment across Australia.

The approval marks a significant regulatory milestone, positioning the CT:VQ technology for clinical use in the healthcare system. The imaging solution enables radiologists and referring clinicians to obtain regional ventilation and perfusion information directly from standard non-contrast chest CT scans, without injections, contrast agents, radiotracers or nuclear medicine infrastructure.

Australia is the latest market to approve CT:VQ, with the technology already holding regulatory clearance across the United States, European Union, United Kingdom, Canada and New Zealand.

4DMedical Managing Director, CEO and Founder Andreas Fouras said the TGA approval represented a pivotal milestone for the company’s local and international growth strategy.

“TGA approval clears the way for CT:VQ to be deployed across Australia and marks a landmark moment for respiratory diagnostics in our home market,” stated Fouras. “Australia is the latest approved market, supporting our global commercial expansion and reinforcing the growing international validation of our technology. Every market we enter contributes to a larger strategic objective. Each approval strengthens the clinical evidence, reimbursement precedent and credibility that together build the case for CT:VQ to become a new standard for functional lung assessment worldwide.”

Australia is well positioned for rapid adoption of the technology due to its existing CT imaging infrastructure. With more than 74 CT scanners per million people, the country ranks among the highest CT-utilisation markets globally and has the second-highest reported CT scanner density worldwide.

The widespread infrastructure is expected to make CT one of Australia’s most accessible functional lung imaging modalities, particularly for regional and rural communities where nuclear medicine services may be limited or unavailable. It also provides a practical solution for smaller hospitals and imaging centres that possess CT scanners but lack nuclear medicine equipment or specialist staffing.

The technology further offers health systems an opportunity to reduce patient exposure to inhaled and injected radioisotopes while minimising associated logistical burden. In addition, it provides a scalable, software-based alternative to traditional ventilation-perfusion imaging, enabling more efficient use of nuclear imaging capacity for advanced procedures such as oncologic theranostics.

With TGA approval now secured, 4DMedical will commence preparation of an application to the Medical Services Advisory Committee (MSAC) to pursue Medicare Benefits Schedule (MBS) reimbursement.

“As the first non-contrast, CT-based ventilation-perfusion solution, CT:VQ expands access to functional lung imaging while leveraging existing healthcare infrastructure. Australia’s exceptional CT scanner density makes it one of the most scalable markets we have entered,” added Fouras. “With TGA approval secured and a reimbursement pathway ahead, 2026 continues to be a defining year for 4DMedical as we expand access to next-generation respiratory imaging for patients, clinicians and health systems around the world.”

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