4DMedical receives CE Mark for CT:VQ™, enabling commercial launch across the European Union

Core Viewpoint - 4DMedical Limited has received CE Mark certification for its CT:VQ™ imaging technology, enabling its commercial launch in the European Union, which is a significant step for the company in expanding its market presence [2][8]. Company Developments - 4DMedical has secured A$83 million in private placement funding to support its growth initiatives, particularly the expansion of CT:VQ™ in Europe [3][10]. - The company is advancing plans to enhance commercial engagement across Europe and collaborate with leading hospitals and clinicians for the adoption and evaluation of CT:VQ™ [10]. Technology Overview - CT:VQ™ is the first non-contrast ventilation-perfusion imaging technology that provides quantitative insights into lung function from routine non-contrast CT scans without the need for radiotracers [4][11]. - The technology combines anatomical clarity with functional mapping, addressing the limitations of traditional imaging methods that focus solely on structural aspects [5][11]. Market Opportunity - The European market presents a substantial opportunity for advanced cardiothoracic imaging, with a population exceeding 450 million and a well-established hospital imaging infrastructure [7]. - Approximately 400,000 nuclear VQ scans are performed annually in the EU, highlighting the clinical need for CT:VQ™ technology [7]. Regulatory Milestones - The CE Mark certification follows the FDA clearance, allowing 4DMedical to rapidly commercialize CT:VQ™ in both the U.S. and EU markets [8][9]. - The technology has already seen early adoption in major U.S. academic medical centers, indicating strong interest and potential for similar uptake in Europe [9].