4DMedical gains CE Mark approval for CT:VQ lung imaging in Europe

4DMedical Limited (ASX: 4DX) received CE Mark certification for its CT:VQ imaging technology, allowing commercial deployment across the European Union. The Melbourne-based medical technology company announced the regulatory approval enables launch in one of the world's largest respiratory imaging markets.

The company simultaneously secured A$83 million in private placement funding from institutional investors to support growth initiatives, including European expansion.

CT:VQ is described as a ventilation-perfusion imaging technology that generates functional lung information from routine non-contrast CT scans without requiring radiotracers or specialized nuclear medicine infrastructure. The technology aims to provide quantitative insights into regional lung function while fitting within existing CT-based workflows.

The European Union, with a population exceeding 450 million and extensive CT scanner infrastructure, represents a significant market opportunity for the technology. 4DMedical estimates approximately 400,000 nuclear VQ scans are performed annually across the EU.

"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 and CEO of 4DMedical. The company now holds regulatory clearance for both the U.S. and EU markets.

The technology is currently deployed at six U.S. academic medical centers including Stanford, Cleveland Clinic, University of Miami, UC San Diego Health, University of Chicago Medicine, and Mayo Clinic. The company plans to advance commercial engagement across Europe and collaborate with hospitals and clinicians on adoption and research initiatives.

4DMedical develops software-based cardiothoracic imaging technology that integrates proprietary algorithms and artificial intelligence to assess lung function and cardiopulmonary disease from clinical imaging.

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