Highlights

  • 4DMedical receives Health Canada approval for CT:VQ™, enabling non-contrast ventilation-perfusion imaging in Canada.
  • Regulatory clearance allows commercial deployment through Philips’ North American distribution arrangement.
  • Canada presents over 800,000 potential annual respiratory CT procedures across hospital-based scanners.

4DMedical Limited (ASX:4DX) has received regulatory approval from Health Canada for its CT:VQ™ technology, clearing the way for commercial use across Canada. The approval classifies CT:VQ™ as a Class II Medical Device under the Medical Devices Directorate framework. This decision expands the company’s regulatory footprint in North America, following earlier clearance in the United States, and allows the technology to be deployed in clinical settings without additional regulatory barriers.

Market scale and healthcare landscape
Canada represents a sizeable healthcare market, with a population exceeding 40 million and gross domestic product above USD 2.1 trillion. The country’s healthcare system includes approximately 560 CT scanners, with about 94 percent installed in hospital environments. Each year, Canada performs more than 6.4 million CT examinations, of which around 12.7 percent are related to respiratory imaging. This translates into more than 800,000 procedures annually that may align with ventilation-perfusion imaging requirements.

Population distribution also plays a role in access and deployment. Around 70 percent of Canadians live south of the 49th parallel, while roughly 90 percent reside within 160 kilometres of the United States border. This geographic concentration places much of the Canadian healthcare network close to existing U.S.-based commercial and clinical support teams.

Philips distribution framework
The Canadian regulatory clearance aligns with the distribution agreement announced between 4DMedical and Philips in early December 2025. Under this arrangement, Philips holds distribution rights for CT:VQ™ across both the United States and Canada. The agreement includes the allocation of dedicated sales and clinical personnel responsible for North American deployment.

With regulatory approvals now in place for both markets, the distribution framework allows CT:VQ™ to be introduced through Philips’ existing hospital and imaging centre relationships across Canada and the United States.

Technology and clinical application
CT:VQ™ is designed to deliver quantitative ventilation-perfusion information using routine, non-contrast CT scans. The technology analyses lung tissue motion and density changes to produce ventilation and perfusion maps without the use of radiotracers or contrast agents. This approach removes the need for nuclear medicine infrastructure and associated handling requirements.

By integrating with standard CT protocols, CT:VQ™ can be used on existing scanners without additional equipment. This enables broader access to ventilation-perfusion imaging, including in regional and community healthcare facilities that may not offer nuclear VQ scanning services.

Addressable imaging market
Nuclear ventilation-perfusion scans form a significant component of respiratory diagnostics. In the United States, more than one million nuclear VQ scans are performed annually, with average reimbursement of about USD 1,150 per scan. Globally, this represents an estimated market value of approximately USD 2.6 billion. The introduction of CT-based alternatives extends ventilation-perfusion imaging into settings previously limited by infrastructure or regulatory constraints.
Share Price Snapshot
4DX was trading 21.721% higher at AUD 2.970 per share as of 16 December 2025.