CT:VQ™ Redefines Lung Imaging: FDA Clearance Makes Non-Contrast V/Q Scans a Reality
In a landmark move for pulmonary diagnostics, 4DMedical’s CT:VQ™ earned FDA 510(k) clearance in September 2025, marking it as the first and only non-contrast ventilation–perfusion (V/Q) imaging solution. The technology is available via routine chest CT scans. With CMS confirming reimbursement under Category III CPT codes (on top of the existing chest CT payment), CT:VQ™ is poised to redefine accessibility and efficiency in functional lung imaging.
4DMedical’s CT:VQ™ Receives FDA 510(k) Clearance; First-and-Only Non-Contrast VQ Imaging
4DMedical, a leader in advanced respiratory imaging, today announces U.S. Food and Drug Administration (FDA) 510(k) clearance for CT:VQ™, the world’s first and only non-contrast, ventilation–perfusion (VQ) imaging solution. In parallel, the U.S. Centers for Medicare & Medicaid Services (CMS) has confirmed reimbursement for CT:VQ under Category III CPT codes; this payment is in addition to existing reimbursement for the underlying chest CT.
Understanding Lung Perfusion: What is it? Why does it matter? And how is it measured?
Lung health is essential for overall wellbeing. A key aspect of healthy lungs is their ability to efficiently transfer oxygen into the blood. This process relies on both the flow of air (ventilation) and the flow of blood (perfusion) through the lungs. While ventilation is about how well air moves in and out, perfusion refers to the movement of blood through the lungs’ fine network of blood vessels. Both are crucial, but today we’ll take a closer look at lung perfusion: what it is, when and why it’s measured, and how advanced imaging technologies are enhancing our understanding of it.
Olympus Launches Emphysema Screening Program Powered by 4DMedical, Expanding Early Diagnosis and Treatment Opportunities
A new peer-reviewed study published in Respiratory Research confirms that 4DMedical’s CT Lung Ventilation Analysis Software (CT LVAS) provides results comparable to those of the gold standard PET method, as well as two additional research techniques for assessing regional lung function. The findings demonstrate a strong association and agreement between 4DMedical’s CT LVAS and PET-ventilation at the lobar level and comparable correlation at the voxel level. Utilizing routine non-contrast CT scans, CT LVAS generates detailed regional ventilation information. This highlights CT LVAS as a safe and contrast-free modality for functional lung imaging, making it an ideal tool for assessing lung function across a range of respiratory conditions.
Reducing the Burden on Healthcare Systems: The Efficiency of 4D Imaging in Respiratory Medicine
Anyone who has faced a health challenge knows that a diagnosis can take time, often, a lot of time. Studies suggest that the average patient can wait 25 to 1,800 days for a diagnosis, and the National Institutes of Health (NIH) reports that this timeline can extend to four to five years for rare or complex diseases.
Lung diseases are challenging to diagnose, as symptoms develop gradually over many years. For instance, a patient with Chronic Obstructive Pulmonary Disease (COPD) might experience a decade of cough, frequent respiratory infections, and breathlessness during exercise before receiving a formal diagnosis.
AI-Driven CT Innovations from 4DMedical Transform COPD Diagnosis and Patient Care
As COPD continues to grow as a global health burden—predicted by the World Health Organization (WHO) to become the third leading cause of death by 2030—innovative AI-driven medical imaging technologies are rapidly advancing diagnosis, staging, and treatment. In a recent Radiology Today article, “Breathing Room,” writer Beth W. Orenstein explores how clinicians are increasingly relying on advanced CT imaging solutions.
Chronic Obstructive Pulmonary Disease (COPD) and the Importance of Lung Imaging
Over 12.5 million Americans live with COPD. The discomfort caused daily by COPD increases rates of anxiety and depression in individuals and can severely limit their ability to work, causing significant financial damage to families. The American Lung Association estimates that the total economic cost of COPD is close to $50 billion each year, including $29.5 billion for direct healthcare expenditures, $12.4 billion for indirect mortality costs, and $8.0 billion for indirect morbidity costs.