4DMedical Limited, the global leader in cardiothoracic imaging software, announces that its latest imaging technology, CT:VQ, has received CE Mark certification for commercial use in the European Union. 4DMedical will quickly launch commercial deployment of CT:VQ across one of the world's largest respiratory imaging markets.

In a separate but concurrent announcement, 4DMedical has secured firm commitments from select institutional investors for an AU$83 million single-tranche private placement. This additional capital will support the Company's growth strategy, particularly the expansion of CT:VQ in Europe.

CT:VQ is the world's first and only non-contrast, ventilation-perfusion imaging technology, providing quantitative functional lung insights from routine non-contrast CT scans without the need for radiotracers or specialised nuclear medicine infrastructure.

Pulmonary disease is fundamentally functional—defined by abnormalities in ventilation and perfusion—yet most routine imaging available to radiologists and pulmonologists remains purely structural. CT:VQ bridges that gap by generating ventilation and perfusion maps, allowing clinicians to visualize regional lung function with the anatomical clarity of CT.

For large medical institutions, CT:VQ is designed to fit within existing CT-based workflows and infrastructure. CT:VQ offers relief from long-standing constraints associated with conventional nuclear VQ imaging, including radiotracer availability, workforce limitations and operational complexity.

The European market represents a significant opportunity for advanced cardiothoracic imaging. With a population of more than 450 million, a highly developed hospital-based imaging infrastructure and an extensive installed base of CT scanners, the EU is well positioned for the adoption of CT-based functional lung imaging. 4DMedical estimates that approximately 400,000 nuclear VQ scans are performed annually across the EU, underscoring the scale of clinical need.

"CE Mark certification for CT:VQ is a significant milestone that opens access to one of the world's largest and most sophisticated healthcare markets," said Andreas Fouras, Managing Director, CEO and Founder of 4DMedical. "Combined with FDA clearance, 4DMedical now has regulatory clearance to rapidly commercialise CT:VQ across both the U.S. and the EU.