4DMedical Limited (ASX:4DX) is a medical technology company focused on respiratory imaging and artificial intelligence. Its patented XV Technology converts standard medical scans into functional lung information, while its portfolio includes XV LVAS, CT LVAS and CT:VQ. During FY2026, the company expanded the commercial and regulatory footprint of CT:VQ across several major healthcare markets while continuing to invest in clinical evidence and customer adoption.

CT:VQ Builds a Broader US Commercial Footprint

CT:VQ moved from regulatory clearance into commercial deployment during FY2026. The technology received US Food and Drug Administration clearance in September 2025, while the US Centers for Medicare & Medicaid Services subsequently confirmed reimbursement of US$650.50 per scan. According to 4DMedical, CT:VQ enables ventilation-perfusion assessment from routine CT imaging without radioactive tracers or contrast agents.

Commercial adoption expanded across US academic medical centres, with Stanford University, Cleveland Clinic, UC San Diego Health, the University of Miami and University of Chicago Medicine operating under commercial arrangements as of 30 June 2026. Cleveland Clinic subsequently entered a three-year Subscription Agreement incorporating committed minimum utilisation.

Another important part of the US strategy is the three-year agreement with SimonMed Imaging. SimonMed operates more than 170 imaging centres across 10 states and agreed to deploy CT:VQ and LDAf on commercial terms using per-scan pricing. The original announcement noted that the agreement was not immediately financially material, making utilisation and scan volumes important factors in determining its eventual Revenue contribution.

By the end of FY2026, technical onboarding across the SimonMed network had been completed and clinical Training finalised, with patient scanning expected to commence.

European Expansion Adds Another Commercial Platform

4DMedical also expanded into Europe through the Acquisition of Vienna-based contextflow, a medical imaging artificial-intelligence company specialising in lung cancer screening and thoracic imaging. The transaction involved upfront consideration of approximately A$18.56 million in cash plus 56,235 4DMedical shares, together with performance-linked contingent consideration.

The acquisition added an established European team, clinical relationships and contextflow’s CE-marked ADVANCE Chest CT product. It also provided 4DMedical with infrastructure for introducing its broader respiratory imaging portfolio into European markets.

By the FY2026 results, contextflow had also been selected for a German lung cancer screening deployment led by Curagita. The agreement covers approximately 25,000 screening procedures across 25 sites over three years and incorporates artificial-intelligence tools for lung nodule detection, emphysema assessment and other imaging workflows.

Clinical Evidence and New Applications

4DMedical is also developing clinical evidence intended to support wider use of CT:VQ. During FY2026, research published in the American Journal of Respiratory and Critical Care Medicine reported that CT:VQ-guided patient selection increased response rates for lung Volume reduction surgery from 46% to 76%.

The company launched the CLEAR clinical evidence programme in June 2026 to assess CT:VQ in patients with suspected acute pulmonary embolism. The programme includes a prospective study comparing CT:VQ with CT pulmonary angiography and is anchored by a clinical research agreement with Mass General Brigham. Approximately US$2 million of funding has been committed to the programme.

Regulatory expansion has continued alongside these clinical initiatives. CT:VQ had been authorised in six markets by the end of FY2026, including the United States, European Union, United Kingdom, Canada, New Zealand and Australia.

Revenue Conversion Remains the Key Challenge

Despite expanding commercial access, 4DMedical remains in a loss-making position. FY2026 Operating Revenue was $7.1 million, while the adjusted net loss was $32.9 million. The company ended the financial year with $278 million in cash, providing funding capacity for continued commercialisation and product development.

Operational activity has increased substantially. The company was delivering SaaS products across 540 sites globally as of 30 June 2026 and produced 344,075 scans during FY2026. However, 4DMedical noted that its established product portfolio remained the main contributor to scan-volume growth, with CT:VQ expected to contribute more as adoption increases.

This means the next stage of development centres on converting regulatory approvals, hospital contracts and network deployments into recurring commercial utilisation. The SimonMed rollout, Philips distribution arrangement, European expansion and clinical programmes provide multiple channels for adoption, but revenue growth will depend on actual scanning volumes, customer uptake and execution across these markets.

Key Insights

4DMedical entered FY2027 with a broader commercial platform than it had a year earlier. CT:VQ has regulatory clearance across multiple jurisdictions, commercial adoption at several US healthcare institutions and access to a large outpatient network through SimonMed.

At the same time, the company’s financial results show that commercial scale is still developing. With operating revenue of $7.1 million against an adjusted net loss of $32.9 million in FY2026, progress in converting its expanded customer footprint into Recurring Revenue remains an important measure of execution.