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Nov 23, 2023

FDA clears 4D Medical's lung imaging technology

May 26, 2020 By Sean Whooley 4DMedical announced that it received FDA

May 26, 2020 By Sean Whooley

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."

Filed Under: 510(k), Food & Drug Administration (FDA), Imaging, Regulatory/Compliance, Respiratory Tagged With: 4DMedical, coronavirus, COVID-19