FDA Clears Adjunctive Lung Ventilation Software for CT

The Food and Drug Administration (FDA) has granted 510(k) clearance for CT LVAS, an adjunctive software that provides detailed analysis of lung ventilation based on computed tomography (CT) scans.

Offering color-coded images of regional airflow and lung ventilation that are overlayed on CT scans, the CT LVAS provides quantifiable assessments of lung volume change and regional lung ventilation heterogeneity, according to 4DMedical, the developer of CT LVAS.

The company said the CT LVAS facilitates regional lung ventilation measurement in thousands of locations in the lungs.

“Having assisted with image interpretation of CT LVAS exams in Australia, I've seen the diagnostic power of adding functional assessment to the structural information provided in standard non-contrast chest CTs,” noted Greg Mogel, M.D., a consultant radiologist at 4DMedical. “CT LVAS allows radiologists to provide a whole new dimension of lung health information to referring clinicians needing answers.”

4DMedical added that the combination of CT LVAS with a forthcoming CT:VQ software, which provides quantitative perfusion assessment based on CT scans, may enhance the diagnosis of pulmonary embolism and assessment of conditions such as chronic obstructive pulmonary disease (COPD).