4DMedical Secures CE Mark for CT:VQ and Raises AU$83 Million for European Expansion

Regulatory Approval and Global Expansion

4DMedical Limited (ASX:4DX) has officially received CE Mark certification for its CT:VQ imaging technology, marking a pivotal step for the company's entry into the European Union. This regulatory milestone allows the Melbourne-based medical technology leader to launch its advanced software across one of the largest respiratory imaging markets in the world. The company plans to immediately begin commercial deployment to meet the high demand for advanced lung diagnostics in the region. Alongside the regulatory news, 4DMedical announced it has secured AU$83 million (approximately $57 million USD) in a private placement from institutional investors. These funds are specifically designated to accelerate international growth and support the commercial rollout of CT:VQ throughout Europe. The successful capital raise follows a period of strong momentum in the United States, where the technology is already being adopted by major medical institutions.

AI-Powered Functional Imaging

4DMedical specializes in creating software that provides deep, quantitative insights into lung function. Its proprietary XV Technology uses artificial intelligence and advanced algorithms to analyze routine clinical images. By integrating these AI tools, the company can deliver high-resolution maps of lung ventilation and perfusion without the need for traditional, invasive procedures. More information on their technology can be found at www.4dmedical.com. CT:VQ is the first technology of its kind to provide ventilation-perfusion insights from standard, non-contrast CT scans. Traditionally, these maps require nuclear medicine infrastructure and the use of radioactive isotopes, which can be limited by supply chain constraints. By utilizing AI to extract this data from routine scans, 4DMedical allows hospitals to use their existing CT hardware to perform comprehensive functional assessments.

Impact on Clinical Workflows

"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," stated Andreas Fouras, CEO and Founder of 4DMedical. He emphasized that the universal limitations of nuclear scanning, such as radiotracer constraints and operational complexity, make the European market a prime candidate for this technology. The software is designed to fit seamlessly into existing hospital workflows, helping clinicians visualize regional lung function with the anatomical clarity of a CT scan. The European market offers a massive opportunity, with approximately 400,000 nuclear scans performed annually. 4DMedical aims to replicate its U.S. success, where the technology is currently deployed at sites like the Cleveland Clinic and Mayo Clinic. With the new funding and regulatory clearance, the company is now moving forward with plans to engage leading European hospitals and research initiatives.