Australian medical technology company 4DMedical (formerly known as 4Dx) says it has received clearance from the FDA to market its four-dimensional XV Technology lung imaging product - XV Lung Ventilation Analysis Software.
4DMedical Founder and CEO Dr Andreas Fouras said, “XV Technology is a valuable respiratory diagnostic tool that provides critical information about the functional state of a patient’s lungs in the treatment of all illnesses of the lungs, such as asthma, emphysema, pulmonary fibrosis and lung cancer."
The company said its XV Technology is designed to provide essential quantitative support for diagnosis and follow up examinations.
“XV can provide real benefits to lung patients and to the healthcare system. In the case of COVID-19, XV can be used to triage patients into the right treatment setting and to quickly determine how well a treatment is working,” said Dr Fouras.
“The FDA clearance we have received means that we can now launch our product in the US, to ensure American hospitals and doctors have access to potentially life-saving insight into the lung function of their patients.”
The company said the XV Technology can be implemented immediately, utilising existing hospital and clinical infrastructure with no capital expenditure or training required, and is available through secure cloud subscription.
Imaging departments undertake an X-ray sequence using existing fluoroscopy equipment. 4DMedical software then identifies and quantifies any functional impairment. A report is sent to the hospital to enable clinicians to determine the most effective treatment course of action. The end-to-end process can be completed and a report generated within three hours.