Cardiothoracic imaging software provider 4DMedical Limited (ASX: 4DX) declared on Monday that it has received CE Mark certification for its CT:VQ imaging technology, enabling commercial deployment across the European Union, as the company separately secured AUD83m in private placement funding to support growth initiatives, including its European rollout.

CT:VQ is the first non-contrast ventilation-perfusion imaging solution, combining anatomical CT imaging with functional lung mapping to deliver quantitative insights into regional lung function without the need for radiotracers or nuclear medicine infrastructure. The technology is designed to integrate into existing CT workflows, addressing longstanding limitations associated with conventional nuclear VQ imaging such as radiotracer supply constraints and operational complexity.

CE Mark approval provides access to a significant addressable market, with the European Union's population exceeding 450 million and an established hospital imaging infrastructure. 4DMedical estimates around 400,000 nuclear VQ scans are performed annually in the region, highlighting substantial demand for functional lung imaging solutions.

The company intends to accelerate commercial engagement across Europe, partnering with hospitals and clinicians on adoption, evaluation and research initiatives. The expansion is supported by fresh capital from an A$83 million single-tranche private placement with institutional investors.

Momentum for CT:VQ is also building in the US, where the technology has been deployed at six leading academic medical centres, including Stanford, Cleveland Clinic, University of Miami, UC San Diego Health, University of Chicago Medicine and Mayo Clinic, demonstrating early clinical adoption and providing a foundation for international growth.

Built on 4DMedical's proprietary XV Technology, CT:VQ generates ventilation and perfusion maps from routine CT scans, enabling clinicians to assess lung function, support diagnosis and guide treatment decisions. The company said the approval and funding position it to scale adoption of its software-based cardiothoracic imaging platform globally.