Australian medical technology company 4DMedical has received the US Food and Drug Administration (FDA) approval for its CT-based lung function scanning software, CT LVAS.
4DMedical designed its CT LVAS software using its patented XV Technology, which is also used in the company’s FDA-approved XV LVAS imaging software for use with fluoroscopy.
CT LVAS leverages a software-as-a-service model to process existing CT scans using sophisticated algorithms and without needing any new capital equipment.
It provides detailed reports, including colour-coded images of regional airflow and lung ventilation, overlayed on the patient’s CT scan.
4DMedical consultant radiologist Greg Mogel said: “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.
“CT LVAS allows radiologists to provide a whole new dimension of lung health information to referring clinicians needing answers. I look forward to sharing this release at the upcoming RSNA.”
According to 4DMedical, clinicians use standard CT images to obtain structural details about patients’ lungs, and they infer information about disease and function using the images.
The CT LVAS software provides data on lung performance, in addition to the structural detail of CT scans.
It enables radiologists to provide objective, data-driven information, supporting diagnosis and treatment options, said the medical device company.
CT LVAS processes scans uploaded from the existing CT equipment, where it analyses and returns a Ventilation Report to the radiologist.
Its Regional Ventilation Visualisation feature measures lung ventilation in several thousands of locations in the lungs and provides region-specific ventilation at deep inspiratory breath-hold.
Furthermore, 4DMedical said that its upcoming CT:VQ technology will enable the visualisation of changes in ventilation and perfusion, facilitating a detailed assessment of V/Q mismatch.
4DMedical founder and CEO Andreas Fouras said: “As we head to RSNA, I am thrilled that reimbursement has been approved for our XV LVAS product designed for fluoroscopy, and to also share FDA clearance for CT LVAS in the US.
“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.”