4DMedical Eyes $2.5B Pulmonary Market With Contrast-Free Imaging Tech
4DMedical targets US$2.5 billion pulmonary embolism market with new clinical program
4DMedical has launched CLEAR (Contrast-free Lung Evaluation for Acute Risk in pulmonary embolism), a clinical evidence programme designed to fast-track its CT:VQ™ imaging technology into the acute pulmonary embolism (PE) market. The initiative expands the company’s obtainable U.S. market from the existing nuclear VQ segment of approximately 1 million scans per annum to include the CTPA-dominated PE segment of roughly 5 million scans per annum, lifting the total addressable opportunity to US$3 billion. 4DMedical has committed approximately US$2 million to fund the CLEAR programme, which is anchored by a clinical research agreement with Mass General Brigham as the lead site.
The announcement represents a sixfold expansion of 4DMedical’s addressable market opportunity in the United States through clinical evidence generation rather than new hardware development.
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Why pulmonary embolism imaging is ripe for disruption
Pulmonary embolism is a major acute cardiovascular condition that results in approximately 600,000–650,000 diagnosed clinical episodes annually in the United States, with the true burden likely higher due to under-diagnosis. In a meaningful proportion of cases, sudden death is the first presentation.
The current imaging landscape is defined by structural inefficiency. CT pulmonary angiography (CTPA) has become the de facto imaging modality for suspected PE, yet utilisation has increased dramatically since 2004. Multiple large health systems have reported 4x growth in CTPA scan volumes despite the introduction of validated clinical decision rules specifically designed to limit unnecessary imaging.
This persistent overuse has been accompanied by declining diagnostic efficiency. Across large cohorts, the positive diagnostic yield of CTPA has been reported in the range of approximately 3–10%, meaning 90–97% of patients undergo iodinated contrast exposure without confirmation of PE. Based on aggregated health-system utilisation trends, total U.S. CTPA imaging for suspected PE is widely estimated at approximately 4–6.5 million studies per annum, with ~5 million scans representing a conservative midpoint estimate.
The structural inefficiency of current PE imaging creates demand for a contrast-free alternative that can reduce costs and patient risk while maintaining diagnostic accuracy.
Three key problems with current PE imaging
- Over-utilisation: Clinical pathways intentionally biased toward exclusion have driven CTPA volumes to significantly exceed disease incidence, with 4x growth since 2004.
- Low diagnostic yield: Only 3–10% of CTPA scans confirm PE, meaning the vast majority of imaging does not result in diagnosis.
- Unnecessary contrast exposure: 90–97% of patients receive iodinated contrast injections without PE confirmation, subjecting large patient volumes to higher-cost imaging and potential contrast-related risks.
What is CT:VQ™ and how does it work?
CT:VQ™ generates quantitative, three-dimensional ventilation and perfusion maps from routine non-contrast inspiratory and expiratory CT scans. The technology enables contrast-free functional lung assessment within standard CT workflows, eliminating the need for iodinated contrast agents while providing detailed imaging data.
The underlying VQ indication is already FDA-cleared, de-risking the regulatory pathway for PE applications. The role of CLEAR is to generate clinical evidence to drive adoption in acute PE settings rather than pursue new regulatory clearance.
CT:VQ™ leverages existing hospital CT infrastructure without requiring new scanner hardware, iodinated contrast agents, or nuclear imaging facilities, creating a capital-light expansion pathway for 4DMedical.
Mass General Brigham partnership anchors CLEAR program
4DMedical has entered into a clinical research agreement with Mass General Brigham (MGB), anchored at Massachusetts General Hospital (MGH), the original and largest teaching hospital of Harvard Medical School and one of the world’s leading academic medical centres.
The CLEAR programme comprises a multi-centre, multinational, prospective, observational study that puts CT:VQ™ head-to-head with CTPA in patients with suspected acute PE. MGH serves as the principal enrolling site, with the ability to extend to additional MGB hospitals. The company has committed total funding of approximately US$2 million to support patient recruitment, imaging analysis, and data generation.
Mass General Brigham is known for generating high-quality clinical research and translating it into routine care, informing clinical practice, advancing standards of care, and improving patient outcomes across major disease areas.
Dr Andreas Fouras, MD/CEO and Founder
“The detection of pulmonary embolism remains a significant problem in emergency medicine. Today, we image too many patients for PE, exposing them to costly and potentially risky contrast, while still missing dangerous clots, contributing to unnecessary death and disease burden.”
The partnership with a Harvard-affiliated academic medical centre provides credibility for evidence generation and positions CT:VQ™ for adoption across major U.S. health systems.
Market expansion multiplies 4DMedical’s opportunity
4DMedical states that CT:VQ™ is displacing nuclear VQ “at pace” in the United States. The CLEAR programme is designed to extend the technology beyond this core market into the materially larger acute PE opportunity, representing a significant step-change in scale.
The market expansion breaks down as follows: the core nuclear VQ market represents approximately 1 million scans per annum, while the acute PE market dominated by CTPA represents approximately 5 million scans per annum. Combined, this lifts 4DMedical’s total U.S. obtainable market to US$3 billion.
Dr Andreas Fouras outlined the broader growth strategy in his commentary, noting that European market entry adds 50% to the company’s addressable market, while PE market entry multiplies the opportunity sixfold. The technology is delivered through a Software-as-a-Service (SaaS) model that integrates with existing hospital infrastructure.
| Market Segment | U.S. Annual Scans | Opportunity |
|---|---|---|
| Nuclear VQ (current target) | ~1 million | Existing market |
| Acute PE (CTPA-dominated) | ~5 million | CLEAR expansion |
| Total Obtainable | ~6 million | US$3 billion |
The PE market represents a step-change in scale for 4DMedical, transforming the company from a nuclear VQ replacement play into a platform addressing the largest acute CT imaging workflow globally.
Investor webinar scheduled for 9 June 2026
4DMedical will host an investor webinar at 11:00am AEST on Tuesday, 9 June 2026, where MD/CEO and Founder Dr Andreas Fouras will discuss recent company developments and host a live Q&A session. Registration links are available via the company announcement.
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4DMedical’s strategic positioning for respiratory imaging leadership
4DMedical’s technology portfolio comprises XV Technology®, XV LVAS®, CT LVAS™, and CT:VQ™, delivered through a Software-as-a-Service model that integrates into existing hospital infrastructure. The company has strengthened its AI capabilities through the acquisition of Imbio in 2023 and contextflow in 2026.
In his closing remarks, Dr Fouras emphasised acceleration across multiple fronts. The company continues to gain share in its core segment as CT:VQ™ displaces nuclear VQ in the United States. Leveraging its capital position, 4DMedical is expanding into new segments through European market entry and the CLEAR-driven PE market opportunity.
Strategic growth drivers for 4DMedical include:
- Core U.S. nuclear VQ displacement momentum
- European market entry (50% market expansion)
- Acute PE market entry via CLEAR (sixfold opportunity multiplication)
- AI capability enhancement through strategic acquisitions (Imbio, contextflow)
The company is executing a multi-pronged growth strategy leveraging clinical evidence, geographic expansion, and technology acquisition to establish respiratory imaging leadership across cardiothoracic applications.
Could 4DMedical’s contrast-free imaging reshape the US$2.5 billion pulmonary embolism market?
4DMedical’s CLEAR programme aims to validate CT:VQ™ technology in acute PE diagnosis, potentially capturing a share of the 5 million annual CTPA scans where 90–97% of patients receive unnecessary contrast exposure. This clinical evidence initiative could multiply the company’s addressable market sixfold without requiring new hardware development.
To explore 4DMedical’s expansion strategy and track progress from the Mass General Brigham partnership, visit the 4DMedical investor centre. The company will host a live investor webinar on 9 June 2026 at 11:00am AEST to discuss recent developments.