4DX Analysis: 4DMedical Secures Regulatory Approval for CT:VQ in Canada

Event: 4DMedical Secures Regulatory Approval for CT:VQ in Canada | Date: 2025-12-15 | Source: ASX Announcements

Canada Approval Unlocks CT:VQ Market Expansion

4DMedical announced on 15 December 2025 that its CT:VQ imaging software has received regulatory approval from Health Canada, paving the way for commercial roll-out in the Canadian market. The approval enables the company to market and sell CT:VQ, which uses CT scans to assess lung ventilation and perfusion, replacing traditional nuclear medicine methods. This follows the product's FDA clearance in the US in September 2025 and aligns with an expanded distribution agreement with Philips, which includes a minimum US$10 million order commitment for CT:VQ. The Canadian market represents a new growth avenue, with potential for hospital adoption similar to the US, where 4DMedical targets replacing a $1.1 billion nuclear VQ market.

The announcement highlights the strategic importance of the Philips partnership for the Canadian launch, as Philips will support commercial efforts. No specific revenue projections for Canada were provided, but the approval is expected to facilitate initial site activations in 2026. This development comes amid slow US ramp-up, with only two sites live since FDA clearance. Source: 4DMedical ASX Announcement - Regulatory Approval in Canada.