4DMedical secures regulatory approval for CTVQ in Canada

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Stock 4DMEDICAL Ltd (4DX.ASX)
Release Time 15 Dec 2025, 9:40 a.m.
Price Sensitive Yes
 4DMedical secures regulatory approval for CTVQ in Canada
Key Points
  • Receives Canadian regulatory approval for CT:VQ, expanding access to non-contrast VQ imaging
  • Strengthens Philips partnership for distribution of CT:VQ across North America
  • Regulatory approval enables immediate commercial deployment through Philips' distribution network
  • Canada represents a significant addressable market with over 40 million population and 560 CT scanners
Full Summary

4DMedical Limited, a global leader in respiratory imaging technology, has announced that it has received regulatory approval from Health Canada for its CT:VQ solution, the world's first and only non-contrast, CT-based ventilation-perfusion imaging technology. This approval marks a significant expansion of 4DMedical's presence in North America, enabling immediate commercial deployment of CT:VQ across Canada through the company's strategic partnership with Philips. Canada represents a substantial market opportunity for CT:VQ, with a population exceeding 40 million and approximately 560 CT scanners, predominantly hospital-based. The Canadian market performs over 6.4 million CT examinations annually, with 12.7% related to respiratory imaging, representing over 800,000 potential CT:VQ procedures per annum. The Canadian approval directly complements 4DMedical's strategic partnership with Philips, announced on 3 December 2025, which includes distribution rights for CT:VQ across both the United States and Canada. Under the agreement, Philips has committed to deploy dedicated sales and clinical specialists carrying North American CT:VQ sales targets. With regulatory approval now secured in both markets, Philips can immediately activate its North American distribution infrastructure for CT:VQ, leveraging its established commercial networks and customer relationships to drive rapid adoption across hospitals and imaging centres.

Outlook

4DMedical expects CT:VQ to rapidly capture significant market share and, over time, displace 100% of nuclear VQ scans. The company also anticipates that the introduction of CT:VQ into the market will drive long-term growth in demand for ventilation-perfusion scans beyond traditional nuclear VQ indications.