4DMedical Ltd (ASX:4DX) is a medical technology company focused on respiratory imaging and artificial intelligence. Its patented XV Technology transforms standard scans into functional insights about the lungs, and its portfolio includes XV LVAS, CT LVAS and CT:VQ, a non-contrast, CT-based ventilation-perfusion imaging technology. The company delivers its products through a software-as-a-service model and has offices in Melbourne and Los Angeles. Andreas Fouras is Founder, Managing Director and CEO.

On 2 October 2026, 4DMedical shares were trading at $4.34, down 0.46%. The company was included in the S&P/ASX 200 index from April 2026, and its full-year results were released in August.

Recent Developments

On 28 August 2026, 4DMedical announced its FY26 full-year results. Key highlights include:

  • Operating revenue was $7.1 million, up 21%, with gross margins above 90%.
  • SaaS products were delivered at 540 sites globally, up 39%.
  • 344,075 scans were produced, up 77%, including a record 105,970 in Q4 FY26.
  • The adjusted net loss was $32.9 million, compared with $35.3 million.
  • The statutory result included a non-cash expense of $164.6 million related to the Fair Value of the Equity component of the Pro Medicus facility.
  • Cash was $278.0 million at 30 June 2026.

The FDA cleared CT:VQ in September 2025, and CMS confirmed reimbursement of US$650.50 per scan. Five US academic medical centres, including Stanford, Cleveland Clinic, UC San Diego Health, University of Miami and University of Chicago Medicine, were operating under commercial terms by 30 June 2026, and Cleveland Clinic renewed with a three-year agreement including committed minimum utilisation. 4DMedical signed a three-year agreement with SimonMed Imaging, a 170-site network, and expanded its distribution agreement with Philips across North America, underwritten by minimum order commitments.

CT:VQ is now authorised in six markets, including the US, EU, UK, Canada, New Zealand and Australia, where TGA approval in June 2026 was followed by paid contracts. A study published in the American Journal of Respiratory and Critical Care Medicine showed CT:VQ-guided patient selection lifted lung Volume reduction surgery response rates from 46% to 76%. The company launched CLEAR, a clinical program targeting the acute pulmonary embolism market, which it says lifts the obtainable US market to US$3 billion. 4DMedical also acquired contextflow, invested in RevealDx and partnered with Azra AI and AstraZeneca. It raised $150 million in January 2026 and $83 million in March 2026.

Underlying SaaS revenue, which excludes contractual true-up payments and non-core Lease income, rose 23%. Other income of $7.5 million comprised government grants and the Research and Development tax incentive. 4DMedical said a leading US academic medical centre completed a 90-day evaluation of CT:VQ and advanced to the next phase of engagement. In Australia, paid contracts were secured with providers including Spectrum Medical Imaging, Garram Medical Imaging, Cancer Radiology and Therapy, Queensland Radiology Services, Perth Radiological Clinic and Macquarie Medical Imaging. The company also appointed Alexander Albert as Vice President Sales, Europe, and secured a lung cancer screening contract in Germany through contextflow covering about 25,000 procedures.

Sector Context

Medical imaging is increasingly using AI and Quantitative Analysis to extract more information from scans. Functional lung imaging can help clinicians assess diseases such as COPD and pulmonary embolism, but adoption depends on clinical evidence, reimbursement and integration into existing workflows.

Medtech companies commercialising new technologies often take time to build revenue, as hospitals evaluate products and secure budgets. Reimbursement codes and distribution partnerships can accelerate adoption. Competition includes established nuclear imaging methods and other AI imaging providers.

In the US, nuclear ventilation-perfusion scans are performed more than one million times a year, and 4DMedical estimates the initial addressable market at more than US$1.1 billion. CT-based alternatives that avoid radioactive tracers may appeal to hospitals with existing CT scanners. Lung cancer screening programs in Australia, Europe and Brazil are also creating Demand for AI-based lung analysis tools.

Medicare Benefits Schedule reimbursement in Australia requires an application to the Medical Services Advisory Committee, supported by clinical and economic evidence, and the process can take time. In the US, reimbursement codes such as HCPCS code G0680 for AI-enabled coronary artery calcium analysis show how payers are beginning to recognise AI-based imaging tools. Partnerships with large equipment makers such as Philips can provide access to established sales channels.

Risks and Uncertainties

4DMedical's revenue remains small relative to its losses and valuation, and commercial adoption may take longer than expected. The CLEAR program must generate evidence to support use in pulmonary embolism. The Pro Medicus Facility creates volatile non-cash charges linked to the share price. Integrating acquisitions such as contextflow carries execution risk. Equity raisings have diluted shareholders, and further Capital may be needed in the future.

The company's statutory loss was significantly affected by the non-cash charge related to Pro Medicus, and future share price movements could lead to further Volatility in reported results.

Competition from other AI imaging providers and established nuclear medicine methods may also slow adoption.

Catalysts Investors Can Watch

Investors may watch for first patient scanning at SimonMed sites, conversion of additional academic medical centres, Philips minimum order progress, CLEAR study milestones, and MBS reimbursement applications in Australia.

Progress on European adoption through contextflow, the AstraZeneca Partnership in Brazil and the GSK pharmaceutical engagement may also be relevant.

Wrapping Up

4DMedical's FY26 result showed growing sites, scans and revenue as CT:VQ moved into commercial use, supported by a large cash balance. Converting regulatory approvals into scan volumes is the key focus for FY27.