FDA Awards Clearance to 4D Lung Imaging Software

4DMedical, an Australian-based medical innovation software company, announced Tuesday it has received 510(k) clearance from the U.S. Food & Drug Administration for its XV Technology™, a four-dimensional lung imaging process.

According to a company statement, XV Technology™ can quickly and automatically analyze functional lung impairments from a single X-ray.

“Our XV Technology™…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,” said Andreas Fouras, Ph.D., 4DMedical founder and chief executive officer. “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.”

As a software-as-a-service diagnostic tool, the XV process applies 4D proprietary algorithms to identify and quantify any functional impairment. Based on company details, the software creates a ventilation report that can be sent to the hospital for clinicians to use in determining the most effective treatment options and strategies for allocating a facility’s resources. 

XV is a secure cloud-subscription service that uses existing hospital and clinical infrastructure to allow imaging departments to electronically send X-rays using existing fluoroscopy equipment to 4D Medical. The entire process, including report generation, lasts three hours, according to company details.

Although the technology is not intended to replace molecular tests as the primary diagnostic method or COVID-19, company officials said, 4DMedical hopes its ventilation reports can play a necessary role in providing quantitative diagnostic support and follow-up for patients who either have or are recovering from the virus.