4DMedical Gains Canadian Approval, Unlocking 800,000 Potential CT:VQ™ Procedures

Regulatory Breakthrough Opens Canadian Market

4DMedical Limited, a pioneer in respiratory imaging technology, has secured a significant regulatory milestone with Health Canada’s approval of its CT, VQ™ system. This approval classifies CT, VQ™ as a Class 2 Medical Device, clearing the path for immediate commercial deployment across Canada. The move complements the company’s recent US regulatory clearance and strengthens its foothold in North America.

Canada’s healthcare landscape presents a compelling opportunity. With a population exceeding 40 million and approximately 560 hospital-based CT scanners, the country performs over 6.4 million CT exams annually. Around 12.7% of these relate to respiratory imaging, translating into a potential addressable market of more than 800,000 CT, VQ™ procedures each year.

Philips Partnership Accelerates Market Access

Central to 4DMedical’s commercial strategy is its partnership with Philips, announced earlier in December 2025. Philips holds distribution rights for CT, VQ™ across both the US and Canada, leveraging its extensive sales and clinical teams to drive adoption. With regulatory approvals now secured on both sides of the border, Philips can activate its established North American infrastructure to rapidly introduce CT, VQ™ to hospitals and imaging centers.

The geographic concentration of Canada’s population near the US border further facilitates efficient collaboration between 4DMedical’s and Philips’ commercial teams, potentially accelerating market penetration and customer support.

Technological Edge Over Traditional Imaging

CT, VQ™ represents a paradigm shift in ventilation-perfusion imaging by eliminating the need for radiotracers or contrast agents. Unlike traditional nuclear VQ scans, CT, VQ™ uses routine non-contrast CT scans to generate detailed ventilation and perfusion maps, enhancing diagnostic precision while simplifying logistics and patient access.

This innovation addresses longstanding limitations of nuclear VQ imaging, such as complex scheduling and regulatory constraints, and integrates seamlessly into existing CT workflows without requiring additional equipment. The technology’s ability to democratize advanced lung imaging extends its reach to rural and community healthcare settings that may lack nuclear medicine facilities.

Market Potential and Future Outlook

The global nuclear VQ scan market is substantial, with over one million procedures annually in the US alone, generating more than US$1.1 billion in revenue. 4DMedical anticipates that CT, VQ™ will rapidly capture significant market share, eventually displacing traditional nuclear VQ scans entirely. Furthermore, the company expects the introduction of CT, VQ™ to stimulate growth in demand for ventilation-perfusion imaging beyond current indications.

CEO Andreas Fouras highlighted the momentum following recent clinical engagements and commercial launches at prestigious institutions such as Stanford and the University of Miami. With regulatory clearances and a strong commercial partner in place, 4DMedical is positioned to scale revenue and transform respiratory diagnostics across North America.