4DMedical Ltd

Invention:	Non-contrast VQ imaging software
Name:	CT:QV™
FDA Approval:	Yes
Pathway:	Class II 510(k)
ASX:	4DX

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INTRODUCTION
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CT:VQ™ is the world's first and only non-contrast ventilation-perfusion (VQ) imaging software. By utilizing Computed Tomography (CT), it enables lung imaging without the radio tracers, contrast dye and specialist infrastructure of nuclear V/Q imaging. In essence, any CT scanner can now be used to deliver non-contrast lung imaging that assesses both ventilation (V) and perfusion (Q).
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CT:VQ achieved FDA 510(k) clearance in Q4 2025, and U.S. Centers for Medicare & Medicaid Services (CMS) have confirmed reimbursement for CT:VQ™ at US$650.50 per scan under the Hospital Outpatient Prospective Payment System (OPPS).

THE STANDARD OF CARE

The respiratory diagnostics landscape has remained largely unchanged for decades, anchored around four legacy modalities—spirometry, chest X-ray, computed tomography (CT), and nuclear V/Q imaging—each defined by distinct trade-offs between function, structure, cost, and accessibility. As the table below shows, these methods continue to suffer from fundamental limitations: spirometry is effort-dependent and insensitive to regional disease; X-ray and CT provide high-resolution structure but no functional data; and nuclear V/Q scans, while uniquely able to assess both ventilation and perfusion, remain costly, low-resolution, and infrastructure-heavy.
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Globally, respiratory diagnostics remain dominated by chest X-ray, which accounts for over two-thirds of all procedures (67%) and roughly US$14.5 billion in annual expenditure. Pulmonary function testing (PFT), including spirometry, follows with 21% of procedures but only US$3.4 billion in spending—reflecting its low per-test cost but limited functional scope. CT imaging represents 12% of total procedures yet drives a disproportionately high US$11.9 billion in spending due to its higher cost and broader diagnostic use. Meanwhile, nuclear V/Q imaging remains a niche modality, capturing just 0.4% of global procedures but still commanding US$1.6 billion annually.

Globally, respiratory diagnostics spending is concentrated in the major developed healthcare markets, led by the United States, followed by Germany, Japan, China, and the UK. Collectively, these countries account for the majority of both procedural volume and total expenditure, reflecting their advanced infrastructure and high adoption of imaging technologies.
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DISRUPTING VQ ANALYSIS: CT:QV™
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CT:VQ™ is the world’s first non-contrast, post-processing software that transforms chest CT scans into quantitative maps of ventilation (V) and perfusion (Q) — without the need for injected contrast or radioisotopes. Delivered as a cloud-based software-as-a-service, it integrates directly into the radiology workflow, returning results alongside the source CT images. The technology provides functional lung imaging from standard CTs, offering a radiation-free, contrast-free alternative to traditional nuclear medicine V/Q scans.

FDA 510(k) cleared and available for investigational use outside the U.S., CT:VQ™ is eligible for reimbursement under Category III CPT codes. Compatible with roughly 14,500 CT scanners across the U.S., it expands access to V/Q imaging at scale, enabling single-appointment assessments and retrospective analysis of prior CTs. The result is a patient-friendly, cost-efficient solution that enhances clinical decision-making in pulmonary medicine.

CT-BASED VENTILATION ANALYSIS: CT-LVAS™

CT LVAS™ (Computed Tomography Lung Ventilation Analysis Software) introduces functional imaging to computed tomography—a modality that has historically been limited to structural assessment. The software transforms standard CT scans into detailed maps of regional lung ventilation, revealing physiological information not accessible through conventional imaging.

Using CT data acquired on existing hospital scanners, CT LVAS quantifies regional ventilation and ventilation heterogeneity to produce a comprehensive, easy-to-interpret report with 4D visualizations. This enables clinicians to evaluate both lung structure and function within a single, contrast-free procedure.
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By extending CT’s capabilities beyond anatomy to physiology, CT LVAS provides a powerful new tool for detecting and characterizing regional lung changes earlier and more precisely. The system requires paired deep-inspiratory and expiratory volumetric CT scans, acquired in the supine position, and is delivered via a secure Software-as-a-Service (SaaS) platform. CT data are uploaded to 4DMedical for cloud-based processing and rapid results delivery.

X-RAY-BASED VENTILATION ANALYSIS: XV-LVAS®

​XV LVAS® (X-ray Velocimetry Lung Ventilation Analysis Software) brings functional imaging to X-ray—a modality historically limited to anatomical visualization. The software transforms standard fluoroscopic lung images into dynamic, quantitative maps of airflow, providing a level of functional detail previously unattainable with X-ray imaging.

Using data acquired from existing hospital fluoroscopy equipment, XV LVAS quantifies regional ventilation and ventilation heterogeneity—recognized indicators of lung health—and presents the results in a comprehensive, easy-to-interpret report featuring 4D (3D + time) video visualizations. Areas of high and low ventilation are clearly highlighted, enabling clinicians to assess lung performance and disease distribution in real time.
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Delivered as a Software-as-a-Service (SaaS) solution, XV LVAS processes fluoroscopic images uploaded to 4DMedical’s secure platform alongside a reference CT. The system provides actionable insights into key functional metrics, including lung volume, ventilation heterogeneity (VH), and ventilation defect percentage (VDP)—all without the need for contrast agents or additional equipment.