25 May Guided Solutions.co.uk: 4DMedical gets FDA clearance for new respiratory diagnostic tool
Posted: May 25, 2020
Australian medical technology company 4DMedical has secured clearance from the US Food & Drug Administration for its lung imaging technology.
The regulator has cleared XV Technology, which is a patented four-dimensional lung imaging process that quickly and automatically analyses any functional lung impairment from a single X-ray.
The new respiratory diagnostic tool has the capacity to offer significant information regarding the functional and structural state of a patient’s lungs to better treat illnesses such as Covid-19, asthma, chronic obstructive pulmonary disease, cystic fibrosis and lung cancer.
XV Technology is a software-as-a-service that can be easily deployed using existing hospital and clinical infrastructure
Available via secure cloud subscription, the XV Technology is a software-as-a-service (SaaS) diagnostic tool that can be deployed immediately by using existing hospital and clinical infrastructure, helping to avoid additional capital expenditure and training.
By using existing fluoroscopy equipment, the imaging departments can electronically send an X-ray to 4DMedical.
4DMedical’s software will allow to analyse and apply advanced algorithms to detect and quantify any functional impairment.
The software enables to generate a ventilation report and sends it to the hospital to help decide the efficient treatment for the patient.
The company’s ventilation reports will provide clinicians with quantitative support for diagnosis and follow up examinations for patients with or recovering from Covid-19.
4DMedical founder and CEO Dr Andreas Fouras said: “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.
“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 clearance to offer its XV Technology in other geographic markets such as Australia, Europe and Asia.”
In April, ALung Technologies secured emergency use authorisation (EUA) from FDA for its Hemolung respiratory assist system (RAS) to treat patients with Covid-19.