FDA grants 510(k) clearance to CT-based lung ventilation software

The FDA has granted 510(k) clearance to CT LVAS, a software that provides information on patient lung function that can be interpreted alongside lung structural details obtained during CT scans, according to a press release.

Through various algorithms, CT LVAS (4DMedical) processes CT scans and then provides radiologists with a report that shows them regional airflow and lung ventilation at “deep inspiratory breath-hold for a mid-coronal slice and three axial slices — upper, middle and lower,” according to the release.

The release further notes that by using CT LVAS, radiologists can send clinicians important data on lung volume change and regional lung ventilation heterogeneity that may help them diagnose patients and choose the proper treatment.

Notably, 4DMedical is also currently developing CT:VQ, a product that uses CT scans to get quantitative blood flow data. According to the release, data from this technology will help clinicians diagnose patients with pulmonary embolism and assess patients with COPD, pulmonary hypertension and pulmonary vascular disorders.

“I am excited by the impact CT LVAS will provide caregivers and patients in the U.S.,” Andreas Fouras, PhD, founder and CEO of 4DMedical, said in the release. “As we head to [Radiological Society of North America], I am thrilled that reimbursement has been approved for our XV LVAS [imaging] product designed for fluoroscopy, and to also share FDA clearance for CT LVAS in the U.S. We also look towards the commercial release of CT:VQ and the opportunity to combine and provide the two sets of highly quantified lung pulmonary information from CT LVAS and CT:VQ.”