29 May : MassDevice.com : FDA clears 4D Medical’s lung imaging technology
4DMedical announced that it received FDA clearance for its XV Technology for analyzing functional lung impairment from a single X-ray.
Australia-based 4DMedical (formerly 4DX), which has a U.S. base in Woodland Hills, Calif., designed the XV Technology as a four-dimensional lung imaging process in the form of a software-as-a-service (Saas) diagnostic tool.
The software rapidly and automatically analyzes and applies algorithms to identify and quantify any functional lung impairment, generates a ventilation report and sends it to the hospital to enable clinicians to determine the course of action for treatment. The end-to-end process can be completed with a report within three hours.
XV Technology is not intended for replacing molecular tests as a primary diagnosis method for COVID-19, but 4DMedical believes its ventilation reports can help provide quantitative support for diagnosis and follow-up examinations, according to a news release.
“Our XV Technology is a valuable new respiratory diagnostic tool,” 4DMedical founder and CEO Andreas Fouras said in the release. “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.”