26 May 2020 - - Australian medical technology company 4DMedical has received clearance from the US Food and Drug Administration to market its XV Technology, the company said.

The XV Technology is a patented four-dimensional lung imaging process that rapidly and automatically analyses any functional lung impairment from a single X-ray. 4DMedical's US operations are based in Woodland Hills, California.

The clearance comes at a time when there has never been a greater focus on respiratory health around the world, as countries deal with the COVID-19 pandemic.

4DMedical's XV Technology process is a software-as-a-service 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 three hours.

4DMedical's XV Technology is supported by 15 years of preclinical and clinical trials and ongoing collaborations with leading hospitals worldwide.

It has also been validated via an extensive vetting process as part of the Australian government's Medical Research Future Fund Frontier Health and Medical Research Program (including international scientific peer review) with the technology being awarded an MRFF Stage One Frontiers grant in 2019 and now being considered for a Stage Two grant.

4DMedical (founded in 2013) changed name to 4DMedical in May 2020.

4DMedical is a medical technology company aiming to deliver the global gold standard in respiratory diagnostics for all lung disorders including: coronavirus, asthma, chronic obstructive pulmonary disease, cystic fibrosis and cancer.