29 May : EIN Newsdesk : US FDA approves 4DMedical’s new respiratory diagnostic tool, XV Technology
Woodland Hills, California
Tuesday, May 26, 2020, 10:00 Hrs [IST]
Australian medical technology company, 4DMedical has received clearance from the US Food & Drug Administration to market its XV Technology, 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.
“Our XV Technology is a valuable new respiratory diagnostic tool,” said 4DMedical founder and CEO, Andreas Fouras, Ph.D. “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 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.
“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,” added Fouras.
4DMedical's XV Technology process 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 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 (MRFF) 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.
“The clinical trials and peer reviews undertaken over the past 15 years in conjunction with the FDA's 510(k) clearance provide a solid foundation for 4DMedical to obtain regulatory approval to offer its XV Technology in other geographic markets such as Australia, Europe and Asia,” said Fouras.
4DMedical is a medical technology company aiming to deliver the global gold standard in respiratory diagnostics for all lung disorders including: coronavirus, asthma, COPD, cystic fibrosis and cancer.