4DMedical Secures US Medicare Reimbursement Approval for CT:VQ Imaging Software

4DMedical (ASX: 4DX) has received reimbursement approval from the US Centers for Medicare & Medicaid Services (CMS) for its CT:VQ lung imaging platform.

The decision follows Food and Drug Administration (FDA) clearance granted last week, aligning regulatory authorisation with a defined payment structure.

Together, the approvals clear the path for commercial rollout of the software across US hospitals and imaging networks.

Framework Provides Certainty

The CMS ruling addresses one of the most significant barriers to adoption by removing uncertainty over how hospitals will be paid for CT:VQ scans.

By classifying the software under Category III Current Procedural Terminology codes and assigning it to a New Technology Ambulatory Payment Classification, the agency has set a reimbursement rate of US$650.50 per scan on top of the standard chest CT fee.

That decision transforms CT:VQ from a promising innovation into a viable service that providers can confidently build into routine clinical workflows.

With both regulatory and financial hurdles removed in close succession, 4DMedical can now focus on driving scale across the world’s largest healthcare market.

Economic Benefits for Providers

The reimbursement structure creates a dual advantage for healthcare facilities by supporting both revenue generation and cost reduction.

Outpatient centres gain an incremental income stream that builds on existing CT infrastructure, while inpatient hospitals working under fixed Diagnosis-Related Group budgets can replace costly nuclear medicine procedures with a streamlined alternative.

This alignment between clinical need and financial sustainability makes CT:VQ particularly attractive to administrators under pressure to balance innovation with efficiency.

The absence of a requirement for new capital equipment further strengthens the economic case, with CT:VQ deliverable through standard CT scans already performed in hospitals, avoiding the significant investment that typically accompanies advanced imaging capabilities.

In a market where new technology often struggles to demonstrate both utility and financial return, the ability to offer improved care while maintaining or lowering costs gives the product a strong competitive position.

Improved Access for Patients

Patients should see tangible benefits as the software expands into clinical use, as CT:VQ provides detailed ventilation–perfusion analysis without radioactive tracers or contrast agents, reducing risks while allowing results to be obtained from routine CT examinations.

The procedure eliminates the need for additional nuclear medicine appointments, simplifying the diagnostic process for individuals already navigating complex respiratory conditions.

By shifting analysis to a platform that relies on widely available CT technology, 4DMedical opens the door for broader diagnostic reach across metropolitan, regional and community healthcare settings.

The change not only enhances safety and convenience for patients but also ensures that the standard of care is less dependent on geography or facility size.

Financial Strength to Support Rollout

The company has reinforced its operational base with additional capital inflows that coincide with the regulatory and reimbursement milestones.

Earlier this week, 4DMedical received $6.0 million in Research and Development Tax Incentive credits, adding to a $10.0m strategic investment from Pro Medicus that lifted the company’s pro forma cash balance to $22.9m at 30 June 2025.

This strengthened financial position gives the company the flexibility to accelerate the commercial deployment of CT:VQ without the delays that often accompany capital-raising efforts.

The funds will also support the advancement of its broader imaging suite, which includes the XV Lung Ventilation Analysis Software and CT LVAS platforms.

‘Broad Commercial Integration’

Chief executive officer Andreas Fouras said the reimbursement decision represents a turning point for the company.

“Certainty around reimbursement, on the heels of our FDA 510(k) clearance, means CT:VQ is ready for immediate and broad commercial integration,” he said, adding that the software’s accessibility “has huge potential to improve healthcare.”

With its balance sheet strengthened and its regulatory and reimbursement pathway secured, 4DMedical is now preparing to accelerate engagement with hospital groups, imaging networks and academic centres across the US.

Management believes the combination of clinical validation, economic incentive and ease of deployment provides a rare alignment of factors that could see CT:VQ quickly establish itself as a new standard in respiratory diagnostics.

The company has positioned itself to convert years of development into meaningful adoption at scale, with the US healthcare system now open to its technology.