FDA clears 4DMedical CT LVAS lung function scanning software

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.

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