4DMedical Gains FDA Clearance For Groundbreaking CT:VQ Imaging Software

4DMedical (ASX: 4DX) has received United States Food and Drug Administration (FDA) clearance for its CT:VQ software, marking a major milestone in respiratory diagnostics.

The technology is the world’s first non-contrast CT-based ventilation-perfusion tool to replace nuclear medicine scans currently used to assess airflow and blood flow in the lungs.

The clearance opens a potential addressable market of more than US$1.1 billion annually in the US alone, with the company positioning for rapid commercial rollout.

Transforming Ventilation-Perfusion Imaging

The CT:VQ platform aims to tackle some of the most persistent barriers in lung imaging.

Traditional ventilation-perfusion scans require patients to undergo two separate procedures involving radioactive tracers, a process that can take more than an hour and places pressure on hospital nuclear medicine resources.

By contrast, CT:VQ draws on existing CT infrastructure to generate detailed ventilation and perfusion maps without additional equipment, tracers or contrast agents.

This approach not only simplifies scheduling and improves patient access, it also promises higher-quality results by producing clear, quantitative images of lung function.

Multiple Conditions Diagnosed

The combination of speed, resolution and accessibility gives clinicians new tools for diagnosing conditions such as pulmonary embolism, asthma and chronic obstructive pulmonary disease while reducing patient risk.

The ability to deploy CT:VQ across the 14,500 scanners already in place across the US also broadens its potential reach.

Smaller and regional hospitals that do not have nuclear medicine departments can now offer patients functional lung imaging, democratising access to what has previously been a resource-intensive procedure.

Clinical Validation and Early Adoption

FDA clearance followed an extensive program of clinical testing that benchmarked CT:VQ against single photon emission computed tomography, the established standard in nuclear ventilation-perfusion imaging.

Side-by-side comparisons showed strong agreement between the two methods, while physicians noted that CT:VQ delivered clearer images and avoided common artefacts caused by tracer clumping or leakage.

This evidence has been supported by early deployments in major US medical centres, with Stanford University and Brooke Army Medical Center having already incorporated CT:VQ into their research programs.

Chief executive officer Andreas Fouras said the regulatory clearance was “a complete redefinition of the standard of care in pulmonary imaging” because it enables doctors to order perfusion scans without exposing patients to radioactive tracers.

He said the company would now work closely with healthcare providers and academic partners to accelerate adoption across the US.

Commercial Rollout and Market Potential

Market opportunity is central to the company’s strategy.

More than one million ventilation-perfusion scans are performed in the US every year, generating annual revenue of about US$1.1 billion.

With reimbursement rates established and workflow integration straightforward, management believes CT:VQ can capture significant share quickly and eventually displace nuclear scans altogether.

At the same time, by removing the need for radioactive tracers and complex handling protocols, CT:VQ could also grow the overall market.

Clinicians may be more likely to order scans when they can perform them rapidly on existing CT equipment, opening the door to wider use in chronic disease management and routine screening.

Strong FY2025 Performance

The regulatory breakthrough comes just days after 4DMedical reported its full-year results.

Operating revenue climbed 56% to A$5.9 million in the 12 months to 30 June 2025, driven by rising adoption of its Software-as-a-Service model.

The company delivered nearly 195,000 scans during the year, with quarterly volumes more than doubling from 2024, highlighting strong momentum in both domestic and international markets.

The group also cut costs by A$6.5m on an annualised basis through a restructuring program, improving its path toward operating leverage.

A A$10m investment from medical imaging giant Pro Medicus (ASX: PME) further bolstered liquidity, leaving 4DMedical with A$16.9m in cash at year end and an additional A$6m expected from an R&D tax credit.