Highlights

  • 4DMedical continues expanding commercial adoption of CT:VQ across leading healthcare institutions globally.
  • The company secured major regulatory approvals, pharmaceutical partnerships, and international market access during FY26.
  • Peer-reviewed clinical research strengthened the validation of CT:VQ in lung surgery planning and respiratory care workflows.

Australian medical imaging technology company 4DMedical Limited (ASX:4DX) has continued attracting significant market attention as its respiratory imaging platform gains momentum across clinical, commercial, and regulatory fronts globally. Over recent months, the company has delivered a series of developments spanning advanced clinical validation, major hospital adoption, pharmaceutical partnerships, regulatory expansion, and Capital market milestones.

Although the announcements were released earlier in 2026, investor focus on the company has remained elevated amid rapid growth in the commercial adoption of its flagship CT:VQ technology and broader SaaS imaging platform. The company has also emerged as one of the strongest-performing healthcare technology stocks on the ASX over the past year, reflecting heightened interest in AI-enabled healthcare diagnostics and advanced imaging solutions.

With a Market Capitalisation exceeding A$2 billion, 4DMedical is increasingly positioning itself as a global participant in next-generation respiratory imaging, particularly in areas linked to precision medicine, pulmonary disease management, and non-invasive functional lung assessment.

Share Performance

On the market front, shares of 4DMedical Limited have remained closely watched by investors amid the company’s expanding global profile and accelerating commercial activity. The stock closed at A$3.32, down 4.05% on 26 May 2026, with a market capitalisation of approximately A$2.05 billion. While shares eased during the latest Trading session, the company has delivered a favourable longer-term performance, rising more than 100% over the past six months and recording substantial gains, up 970.97% over the past year as investor interest in healthcare technology, AI-enabled imaging, and respiratory diagnostics continued to strengthen.

Clinical Validation Strengthens CT:VQ Positioning

One of the company’s most important recent milestones came through the publication of a peer-reviewed clinical study evaluating CT:VQ in the American Journal of Respiratory and Critical Care Medicine (AJRCCM), widely regarded as one of the world’s leading respiratory medicine journals.

The study examined how quantitative CT-derived imaging metrics could improve patient selection for lung Volume reduction surgery (LVRS), a specialised intervention typically performed in advanced emphysema cases. Researchers analysed pre-operative CT scans from patients undergoing bilateral LVRS procedures and assessed how functional ventilation and perfusion data could assist in identifying patients most likely to benefit from surgery.

According to the findings, integrating CT:VQ-derived perfusion analysis alongside anatomical imaging significantly improved the projected success rate of patient selection. The study indicated that CT:VQ-guided selection could achieve a response rate of approximately 76%, compared with historical rates closer to 46% to 48%.

The publication represented more than a scientific achievement. For 4DMedical, it also provided independent validation of the commercial and clinical value proposition underpinning CT:VQ.

Unlike traditional nuclear medicine ventilation-perfusion imaging, CT:VQ generates functional lung imaging insights directly from existing non-contrast CT scans. The technology eliminates the need for contrast agents, radiotracers, or additional specialised imaging infrastructure.

This capability potentially allows healthcare providers to integrate functional lung assessment earlier within standard clinical workflows while improving procedural planning and reducing unnecessary invasive interventions.

The research was also presented at the American Thoracic Society (ATS) International Conference 2026 in Orlando, one of the largest global respiratory medicine events. Exposure at ATS further increased visibility among pulmonary specialists, radiologists, and healthcare institutions evaluating emerging respiratory imaging technologies.

Commercial Adoption Across Leading Medical Centres

Beyond clinical validation, 4DMedical has also been accelerating commercial deployment of CT:VQ across major healthcare institutions, particularly within the United States.

The company confirmed that University of Chicago Medicine expanded its existing Partnership with 4DMedical to include a commercial CT:VQ agreement supported by an initial pre-paid scan package. The institution became the fifth major U.S. Academic Medical Centre (AMC) to commercially adopt the platform.

Other prominent institutions already deploying CT:VQ include Stanford University, Cleveland Clinic, University of Miami, and UC San Diego Health. Collectively, these organisations represent some of the most influential pulmonary and cardiothoracic centres in the United States healthcare system.

The company also announced that Mayo Clinic commenced a 90-day evaluation program for CT:VQ during March 2026. Although not yet a commercial agreement, the evaluation represented another high-profile institutional engagement that could potentially expand future adoption opportunities.

Management has consistently highlighted the importance of securing leading AMCs as early reference sites capable of influencing broader market adoption trends. Academic hospitals frequently serve as opinion leaders within healthcare ecosystems, particularly for emerging diagnostic technologies and advanced imaging workflows.

The growing network of institutions evaluating or adopting CT:VQ supports 4DMedical’s broader strategy of establishing thought Leadership within respiratory imaging and pulmonary diagnostics.

Regulatory Expansion Opens Global Markets

Another major driver of investor interest has been the company’s rapid progress in securing international regulatory approvals.

During FY26, CT:VQ received CE Mark certification, enabling commercial deployment across the European Union. The approval significantly expanded the company’s addressable market by opening access to one of the world’s largest respiratory imaging regions.

The European healthcare market represents a substantial opportunity due to the extensive use of CT imaging across respiratory care pathways and ongoing limitations associated with traditional nuclear medicine infrastructure.

Following the CE Mark certification, the company also secured UKCA certification, permitting deployment across healthcare providers in the United Kingdom.

Together, these approvals mean CT:VQ now holds regulatory clearance across the United States, European Union, United Kingdom, Canada, New Zealand, and additional international markets.

The broadening regulatory footprint supports 4DMedical’s ambition to scale commercial operations internationally while increasing visibility among global respiratory medicine specialists and research institutions.

The company also secured Canadian clearance for its Coronary Artery Calcium (CAC) analysis solution, further expanding its cardiopulmonary imaging portfolio.

Importantly, the United States Centers for Medicare & Medicaid Services (CMS) established a dedicated reimbursement pathway for AI-enabled opportunistic CAC analysis. Reimbursement infrastructure often plays a critical role in healthcare technology adoption, particularly within hospital systems focused on balancing clinical outcomes with operational efficiency.

For 4DMedical, reimbursement progress strengthens the economic case supporting broader integration of AI-enabled imaging analytics into routine healthcare workflows.

Pharmaceutical Partnerships Expand Strategic Reach

In addition to healthcare institutions, 4DMedical has also been expanding into pharmaceutical imaging analytics.

The company announced a contract with global pharmaceutical company GlaxoSmithKline to provide quantitative lung imaging analytics supporting pulmonary Drug Development and clinical research programs.

The agreement builds on the company’s broader pharmaceutical engagement strategy and follows existing collaborations with AstraZeneca.

Under the arrangement, 4DMedical will Supply advanced imaging biomarkers capable of assessing lung structure and function across clinical trial cohorts. Quantitative imaging analytics are increasingly important in pharmaceutical development as companies seek more precise methods for patient stratification, disease monitoring, and treatment assessment.

Management indicated that Demand for scalable imaging biomarkers continues to grow among biopharmaceutical companies focused on respiratory disease therapies.

The pharmaceutical market represents a potentially significant long-term opportunity for 4DMedical because imaging analytics can support clinical trial design, endpoint measurement, and longitudinal disease monitoring across multiple therapeutic areas.

By expanding relationships within both hospital systems and pharmaceutical research environments, the company is broadening the commercial applicability of its imaging platform beyond traditional diagnostic imaging markets.

SaaS Growth and Operational Momentum Continue

4DMedical’s operational metrics during FY26 also reflected continued expansion across its SaaS Business model.

The company reported that its software products were now deployed across 477 sites globally, representing year-over-year growth of 32%. Scan volumes also continued increasing sharply, with the company producing a record 86,200 scans during the March quarter alone.

Year-to-date scan volumes reached approximately 240,000 scans, reflecting increasing utilisation across both structural and functional imaging products.

Underlying SaaS Revenue increased 24% year-to-date, while customer receipts also recorded solid growth. Gross margins remained above 90%, highlighting the scalability characteristics often associated with software-based healthcare platforms.

The company’s financial position strengthened considerably following two institutional placements completed during FY26, which together raised approximately A$233 million.

Management stated that proceeds would support commercial rollout activities, customer onboarding, evidence generation initiatives, and international expansion, particularly across Europe.

4DMedical also secured inclusion within the S&P/ASX 200 index during April 2026, marking another important milestone for the company. Inclusion in the benchmark index increases visibility among institutional investors and passive Investment funds while broadening Shareholder exposure.

CT:VQ Positioned Within a Large Addressable Market

A central component of 4DMedical’s Long-term Growth thesis is the sizeable market opportunity associated with ventilation-perfusion imaging.

Traditional nuclear VQ scans remain widely used in pulmonary embolism assessment and broader respiratory diagnostics. However, conventional approaches often require specialised infrastructure, radiotracers, and additional workflow complexity.

CT:VQ aims to simplify this process by leveraging existing CT scanners and standard imaging workflows.

Management estimates that more than one million nuclear VQ scans are performed annually across the United States, representing an addressable domestic market exceeding US$1.1 billion annually. Globally, the market opportunity is estimated at more than US$2.6 billion.

Importantly, CT:VQ can potentially expand access to advanced ventilation-perfusion imaging within regional and community healthcare facilities that may not possess nuclear medicine infrastructure.

This accessibility advantage could support broader adoption over time, particularly if healthcare providers increasingly prioritise workflow efficiency, cost optimisation, and non-invasive imaging solutions.

The company believes CT:VQ may eventually displace portions of the traditional nuclear VQ imaging market while also driving entirely new demand categories.

Growing Focus on Precision Respiratory Medicine

The broader healthcare industry is increasingly shifting toward precision medicine and data-driven diagnostics, particularly within chronic disease management.

Respiratory diseases such as emphysema, COPD, pulmonary fibrosis, and pulmonary embolism continue to represent significant global healthcare burdens. Early diagnosis, functional imaging assessment, and personalised treatment planning are becoming increasingly important across respiratory care pathways.

4DMedical’s technology sits within this evolving healthcare landscape by combining imaging analytics, AI, and functional assessment capabilities.

The company’s XV Technology® platform converts standard imaging scans into dynamic functional lung insights capable of supporting earlier disease detection and more personalised clinical decision-making.

As hospitals, clinicians, and pharmaceutical companies continue adopting advanced imaging analytics, 4DMedical appears positioned to participate in a rapidly evolving segment of healthcare technology.

Conclusion

4DMedical has entered a pivotal phase in its growth trajectory as clinical validation, commercial adoption, regulatory expansion, and institutional visibility continue accelerating simultaneously.

The publication of peer-reviewed CT:VQ research in a leading respiratory medicine journal added significant scientific credibility to the company’s platform, while expanding hospital adoption and pharmaceutical partnerships strengthened commercial momentum.

At the same time, major regulatory approvals across Europe and the United Kingdom have substantially expanded the company’s international market opportunity.

Supported by a strengthened Balance Sheet, increasing SaaS scale, and growing institutional recognition, 4DMedical is continuing to position itself as an emerging global player in respiratory imaging and AI-driven healthcare diagnostics.

While execution risks remain typical of high-growth healthcare technology companies, the pace of recent developments has reinforced investor focus on the company’s long-term commercial potential within precision respiratory medicine.