www.fdanews.com/articles/197291-dmedicals-lung-imaging-technology-cleared
4DMedical’s Lung-Imaging Technology Cleared
May 27, 2020
Australian medtech company 4DMedical has earned 510(k) clearance from the FDA for its XV technology that uses an X-ray to analyze lung impairment.
The diagnostic software uses a single X-ray to analyze lung impairment and provides information on the functional and structural state of a patient’s lungs. Hospitals can send X-rays to 4DMedical for analysis.
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,” the company said.