The U.S. Food and Drug Administration (FDA) has given 510(k) clearance to 4DMedical for CT LVAS, its advanced lung function imaging software.
CT LVAS software processes existing CT scans using sophisticated algorithms derived from aerospace technology. The software measures lung ventilation in tens of thousands of locations in the lungs. The Regional Ventilation Visualizations provide region-specific ventilation at deep inspiratory breath hold for a midcoronal slice and three axial slices (upper, middle, and lower).
The regional ventilation data is quantified in lung volume change and regional lung ventilation heterogeneity. Color-coded images of regional airflow and lung ventilation that are overlaid on a CT image are also generated.
CT LVAS is designed to be combined with the company's works-in-progress CT:VQ, software that will enable quantitative perfusion data and visualizations to be extracted from CT scans. The combination will produce a highly quantified assessment of lung performance, according to 4DMedical.
![Axial images from unenhanced calcium score cardiac CT (left) and curved planar reformation images from CT angiography (right) show that higher long-term exposure to air pollution is associated with greater coronary artery calcium and more obstructive coronary artery disease (CAD). Top row: Images in a 68-year-old male patient with higher 10-year mean ambient air pollution exposure (7.9 μg/m3 for particulate matter measuring ≤2.5 μm in diameter [PM2.5] and 17.4 parts per billion [ppb] for NO2) with extensive CAD (coronary artery calcium score [CACS] >1,000 and obstructive CAD [≥70% diameter stenosis]). Bottom row: Images in a 57-year-old female patient with lower 10-year mean ambient air pollution exposure (6.3 μg/m3 for PM2.5 and 4.6 ppb for NO2) with no CAD (CACS = 0 and no obstructive stenosis).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/06/hanneman.r6SMLzkezo.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
