4DMedical Secures CE Mark for Revolutionary CT:VQ™ Lung Imaging Technology, Opens European Market
Key Insights
4DMedical (search)'s CT:VQ™ (search) technology received CE Mark certification, enabling commercial launch across the European Union's 450 million population healthcare market.
The world's first non-contrast ventilation-perfusion imaging solution generates functional lung insights from routine CT scans without requiring radiotracers or specialized nuclear medicine infrastructure.
The company secured AU$83 million in private placement funding to support European expansion, building on successful deployment at six leading U.S. academic medical centers.
4DMedical (search) Limited has achieved a significant regulatory milestone with CE Mark certification for its CT:VQ™ (search) imaging technology, clearing the path for commercial deployment across the European Union. The Australian medical technology company (ASX:4DX) simultaneously announced securing AU$83 million in private placement funding to support its European expansion strategy.
Revolutionary Imaging Technology Addresses Clinical Gap
CT:VQ™ (search) represents the world's first and only non-contrast, ventilation-perfusion imaging technology, providing quantitative functional lung insights from routine non-contrast CT scans without requiring radiotracers or specialized nuclear medicine infrastructure. The technology bridges a critical gap in respiratory medicine, where pulmonary disease is fundamentally functional—defined by abnormalities in ventilation and perfusion—yet most routine imaging remains purely structural.
"Pulmonary disease is fundamentally functional—defined by abnormalities in ventilation and perfusion—yet most routine imaging available to radiologists and pulmonologists remains purely structural," according to the company's announcement. CT:VQ™ (search) generates ventilation and perfusion maps that allow clinicians to visualize regional lung function with the anatomical clarity of CT.
European Market Opportunity
The European market presents substantial commercial potential for advanced cardiothoracic imaging solutions. With a population exceeding 450 million, highly developed hospital-based imaging infrastructure, and an extensive installed base of CT scanners, the EU is well-positioned for adoption of CT-based functional lung imaging. 4DMedical (search) estimates approximately 400,000 nuclear VQ scans are performed annually across the EU, highlighting the scale of clinical need.
"CE Mark certification for CT:VQ™ (search) 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 (search). "Combined with FDA clearance, 4DMedical now has regulatory clearance to rapidly commercialise CT:VQ™ across both the U.S. and the EU."
Addressing Nuclear VQ Imaging Limitations
For large medical institutions, CT:VQ™ (search) is designed to integrate within existing CT-based workflows and infrastructure. The technology offers relief from long-standing constraints associated with conventional nuclear VQ imaging, including radiotracer availability, workforce limitations, and operational complexity.
Fouras emphasized the universal clinical need: "The limitations of nuclear VQ scanning—radiotracer constraints, limited access and operational complexity—exist across healthcare systems globally. Europe has the clinical expertise, imaging infrastructure and research leadership to play a major role in the adoption and evidence generation for this technology."
Building on U.S. Success
The CE Mark follows growing momentum for CT:VQ™ (search) in the United States, where the technology is now deployed at six leading academic medical centers: Stanford (search), Cleveland Clinic, University of Miami, UC San Diego Health (search), University of Chicago Medicine, and Mayo Clinic. 4DMedical (search) believes this early adoption by major U.S. institutions demonstrates strong interest among leading radiology and pulmonary teams and provides a blueprint for European expansion.
Technology Foundation
CT:VQ™ (search) is built on 4DMedical (search)'s patented XV Technology®, designed to provide quantitative ventilation and perfusion insights within familiar CT workflows without requiring radiotracers. The company positions itself as the global leader in cardiothoracic imaging software, creating advanced software-based imaging technology that integrates proprietary algorithms and artificial intelligence.
4DMedical (search) is now advancing plans to expand commercial engagement across Europe and collaborate with leading hospitals and clinicians on adoption, evaluation, and research initiatives for CT:VQ™ (search).