How 4DMedical’s CT:VQ is rewriting the rules of lung imaging—no radiotracers, no waiting rooms, just pixels

For decades, diagnosing conditions like pulmonary embolism or chronic thromboembolic pulmonary hypertension required patients to undergo complex nuclear medicine scans. These procedures typically involved breathing radioactive gases, receiving intravenous injections of tracers, and waiting up to 90 minutes while gamma cameras recorded airflow and perfusion patterns in the lungs. That model is now under serious threat from a new software-defined paradigm—and at the center of it is Australian company 4DMedical.

On September 1, 2025, 4DMedical Limited (ASX:4DX) announced it had secured FDA 510(k) clearance for its flagship CT:VQ platform. This milestone makes CT:VQ the first and only non-contrast, CT-based imaging modality capable of delivering full ventilation-perfusion (VQ) data from standard chest CT scans—without the need for radiotracers, contrast agents, or dedicated nuclear equipment.

Unlike traditional VQ imaging, which demands specialized facilities and complex scheduling logistics, CT:VQ operates entirely through software. It analyses regional lung tissue motion and density changes to generate comprehensive maps of ventilation and perfusion. The result is a diagnostic solution that hospitals can deploy across the 14,500+ CT scanners already installed throughout the U.S. healthcare system. CT:VQ is effectively turning those machines into real-time functional imaging tools, giving clinicians new visibility into how patients breathe and circulate air—without any radioactive exposure.

With over 1 million nuclear VQ scans performed annually in the U.S. at an average reimbursement rate of $1,150, the immediate domestic addressable market for CT:VQ is estimated at more than USD $1.1 billion. Globally, that figure could be more than twice as large. Unlike other innovations that require hardware overhauls, CT:VQ’s software-only model makes it instantly scalable and attractive for both large hospital networks and underserved rural clinics that may lack nuclear infrastructure altogether.

Why this breakthrough in AI-powered CT imaging is seen as a turning point in pulmonary diagnostics

What sets CT:VQ apart is not only its ability to replace nuclear medicine scans but also its robust clinical validation across multiple use cases. The FDA clearance was supported by a detailed performance package that included direct comparisons against SPECT—the current gold standard in nuclear VQ imaging. Physicians and radiologists participating in blinded studies consistently rated CT:VQ’s results as diagnostically equivalent or superior, particularly noting the platform’s clearer images and lack of artefacts caused by radiotracer clumping or leakage.

The technology has already been used in research deployments at Stanford University and the U.S. Department of Defense’s Brooke Army Medical Center, with early results presented at the 2025 American Thoracic Society (ATS) conference. These studies demonstrated that CT:VQ is not only viable for acute diagnosis—such as pulmonary embolism—but also shows potential in chronic condition monitoring, post-COVID lung assessments, and even population-level screening programs. This functional versatility positions CT:VQ as more than just a replacement—it is an expansion of the VQ imaging category into new clinical terrain.

Because CT:VQ requires no contrast agents or radioactive tracers, it is well-suited for repeat use. That opens doors to new CPT reimbursement codes for longitudinal monitoring, particularly for chronic diseases like COPD and asthma. And because the scans are derived from routine chest CTs already captured for other purposes, the marginal cost of layering on CT:VQ analysis could be low, encouraging broader adoption by physicians, radiologists, and administrators looking to enhance diagnostic value without inflating budgets.

How the Philips reseller deal may unlock massive U.S. government market access for CT:VQ

A major catalyst for 4DMedical’s commercial rollout is its reseller agreement with Philips, signed in Q3 FY2025. Under this five-year deal, Philips holds exclusive distribution rights to offer 4DMedical’s software products—including CT:VQ—to U.S. government institutions, including the Department of Veterans Affairs (VA) and Department of Defense. Philips also has non-exclusive rights for the broader U.S. commercial market.

Following the agreement, over 200 Philips sales representatives were trained to market 4DMedical’s products, and the CT:VQ platform was formally added to Philips’ product catalogue. The significance of this is hard to overstate. Philips is one of the most entrenched vendors within U.S. government healthcare, with over half of VA clinics already using its equipment. This gives 4DMedical an immediate foothold into a high-volume, reimbursement-ready customer base at the national level.

In April 2025, Philips North America CEO Jeff DiLullo gave Congressional testimony before the U.S. House Committee on Veterans’ Affairs, highlighting CT:VQ as a tool that could modernize lung health diagnostics for millions of veterans. He praised the technology’s ability to deliver detailed lung scans without radioactive exposure or invasive procedures and positioned it as a critical upgrade to the VA’s respiratory care toolkit. For a partner company like 4DMedical to receive this level of federal advocacy from Philips is rare—and signals deep commercial alignment at the highest levels of the U.S. healthcare system.

What this means for 4DMedical’s SaaS business model and how scan volume is scaling globally

4DMedical’s technology suite—including CT:VQ, XV LVAS, IQ-UIP, SeleCT, and LDAi—is delivered entirely via SaaS. That business model is now starting to pay off. For FY2025, the company reported operating revenue of AUD $5.9 million, up 56% YoY, with software-driven revenue contributing AUD $5.7 million. Gross margins exceeded 90%. Meanwhile, customer receipts increased 87% to AUD $5.4 million, supported by rapid growth in scan volumes and site deployments.

The company is now live at 388 sites globally—up from 242 in FY2024—representing 60% YoY growth. Total scans performed during the year reached 194,789, with 74,000 in Q4 alone. Importantly, this includes both commercial scans and non-revenue-generating deployments used to seed high-potential clients such as major U.S. Academic Medical Centers.

A cost-reduction initiative launched in Q3 FY2025 is already generating AUD $6.5 million in annualised savings, without affecting clinical rollout or R&D productivity. As the company reduces reliance on early-stage development and shifts into product commercialisation, its operating leverage is expected to improve. Additionally, a strategic investment of AUD $10 million from Pro Medicus in FY2025 helped boost the company’s cash position to AUD $16.9 million by June 30, providing further stability as it scales into FY2026.

Why this could be the breakout moment investors have been waiting for in imaging SaaS

To many investors tracking the medtech sector, 4DMedical now resembles something more than a clinical-stage biotech. It is beginning to look like a medtech SaaS platform with high margins, a large addressable market, and proven clinical traction. CT:VQ is already being called a potential “MRI moment” for lung imaging—not because it replicates existing workflows, but because it fundamentally redefines them.

With FDA clearance secured, government sales channels activated, and global site deployments rising, 4DMedical appears ready to move from story stock to revenue stock. If CT:VQ adoption builds momentum in U.S. hospitals and new billing pathways emerge for functional lung screening, the company may well transition into a dominant force in respiratory diagnostics. Add to that its IP position, SaaS delivery, and Philips-backed distribution, and forum investors are rightly asking whether this could be the early innings of a global imaging disruptor.

At AUD 0.77, 4DX is trading near the upper end of its 52-week range, up more than 75% year to date. But if 4DMedical can execute on its commercial rollout and deepen its footprint across the U.S. and Australian healthcare systems, the stock’s current valuation may only reflect the beginning of a larger narrative—one where software defines not just diagnostics, but the very structure of care delivery in lung health.