4DMedical (ASX:4DX) secured CE Mark clearance for its pioneering CT:VQ software.
The regulatory milestone permits the commercial sale of the technology across the European Union, marking a critical expansion of the company’s pulmonary function portfolio.
CT:VQ is a breakthrough tool that provides high-resolution quantitative analysis of both ventilation and perfusion from routine, non-contrast CT scans, eliminating the need for invasive procedures or radioactive contrast agents.
To fuel the aggressive entry into the European market, the company simultaneously announced a successful $83 million placement.
The capital injection is earmarked to scale commercialisation efforts, build out local sales infrastructure, and integrate CT:VQ into the existing healthcare systems of major European nations.
The funding ensures 4DMedical is well-positioned to meet the growing demand for sophisticated lung imaging that can identify conditions such as emphysema, pulmonary hypertension, and interstitial lung disease earlier and more accurately than traditional methods.
The recent regulatory approval completes a comprehensive global sweep for CT:VQ, which already holds clearances in the United States, Canada, and Australia.
With a portfolio that now spans pulmonary function, structure, and cardiovascular diagnostics, 4DMedical is rapidly transforming from an innovative startup into a dominant global player in medical technology.