FDA Grants Clearance to 4DMedical's CT LVAS Lung Function Scanning Software

23 November 2023

4DMedical, a leading developer of sophisticated lung function imaging software, has obtained FDA clearance for its CT LVAS™, a CT-based ventilation product. This clearance is an extension of the approval received for the XV LVAS® imaging software, designed for use with fluoroscopy in the United States. The recent FDA clearance for CT LVAS aligns with the imminent launch of 4DMedical's CT:VQ™, a product set to derive quantitative perfusion (blood flow) data and visualizations from CT scans. 

While conventional CT images provide structural details of the lungs, the combination of CT:VQ and CT LVAS introduces an additional layer of information on lung performance, bridging an essential gap for radiologists to deliver more informed, data-driven diagnoses and treatment plans. The CT LVAS software processes existing CT scans through advanced algorithms inspired by aerospace technology. The resulting detailed reports present color-coded images illustrating regional airflow and lung ventilation, seamlessly integrated with the patient's CT scan. Operating on a software-as-a-service model, CT LVAS requires no new capital equipment, as it efficiently processes scans from existing CT machines. 

Radiologists receive the analyzed data in the form of a Ventilation Report. CT LVAS stands out by measuring lung ventilation in tens of thousands of locations, offering Regional Ventilation Visualizations specific to deep inspiratory breath-hold for a mid-coronal slice and three axial slices—Upper, Middle, and Lower. This comprehensive data quantifies regional lung ventilation heterogeneity and lung volume change, providing radiologists with an enhanced and nuanced understanding of lung function.

Source: prnewswire.com