Imvaria gets FDA marketing authorization for Fibresolve

The U.S. Food and Drug Administration (FDA) has cleared Imvaria for the use of Fibresolve, a digital biomarker tool that uses AI to guide noninvasive diagnosis of lung fibrosis with a focus on idiopathic pulmonary fibrosis.

The company is touting this as the first-ever FDA authorization of a diagnostic tool of any type in lung fibrosis, as well as the first FDA breakthrough-designated AI diagnostic tool with simultaneously adopted current procedural terminology (CPT) billing codes by the American Medical Association (AMA) in any disease.

The authorization will speed up the medical community’s access to Fibresolve for diagnosing lung fibrosis. The company said the tool serves as an option before other more invasive options are considered.

Data from patients with suspected interstitial lung disease is run through Imvaria’s AI-trained algorithm to provide noninvasive adjunct information to support appropriate treatment, the company said. It added that the tool is also expected to save thousands of dollars per person for each test.