Australian medical technology company 4DMedical has received FDA clearance to market its XV Technology, a patented four-dimensional lung imaging process that measures lung function in real time.

The 4DMedical image analysis technology analyzes scanned images acquired from fluoroscopy imaging equipment already installed and available in hospitals and imaging suites. The images are run through 4DxV’s unique, proven algorithms to reconstruct the flow of air throughout all airways in the lung.

“Our XV Technology is a valuable new respiratory diagnostic tool,” says 4DMedical founder and CEO Andreas Fouras, PhD. “It provides critical information about the functional and structural state of a patient’s lungs in the treatment of illnesses such as COVID-19, asthma, chronic obstructive pulmonary disease, cystic fibrosis, and lung cancer.”

The FDA clearance is well-timed to enable U.S. clinicians to evaluate patients with COVID-19.

“FDA clearance means we can fast-track our ‘go-to-market’ strategy to ensure hospitals and doctors in the United States have almost immediate access to our XV Technology Ventilation Reports,” adds Fouras.

XV Technology is a software-as-a-service (SaaS) diagnostic tool, available through secure cloud subscription, and can be implemented immediately, utilizing existing hospital and clinical infrastructure with no capital expenditure or training required. Imaging departments simply electronically send an x-ray (using existing fluoroscopy equipment) to 4DMedical.

XV Technology is not intended to replace molecular tests as the primary diagnosis method for COVID-19; however, 4DMedical believes its ventilation reports will prove essential in providing quantitative support for diagnosis and follow-up examinations for patients with, or recovering from COVID-19.

4DMedical software then rapidly and automatically analyzes and applies its proprietary algorithms to identify and quantify any functional impairment. The software generates a ventilation report and sends it to the hospital to enable clinicians to determine the most effective treatment course of action and allocation of finite hospital resources. The end-to-end process can be completed and a report generated within 3 hours. 

For more information, visit 4DMedical.