FDA clears Fibresolve to help diagnose IPF

Doctor Analyzing Lungs on Virtual Screen.

The U.S. Food and Drug Administration (FDA) has authorized the use of Fibresolve, a digital biomarker solution that uses artificial intelligence (AI), to guide safe, non-invasive diagnoses of lung fibrosis. The announcement marks the FDA’s first authorization of a diagnostic tool for any type of lung fibrosis. Additionally, it becomes the inaugural FDA Breakthrough Device for any disease to simultaneously receive CPT billing codes by the American Medical Association (AMA).

Developed by IMVARIA, Fibresolve has a focus on idiopathic pulmonary fibrosis (IPF) but may be used to help detect other lung diseases marked by fibrosis. Conditions characterized by lung fibrosis can be life-threatening, especially IPF. 

“Fibresolve serves as an adjunct to clinicians in assessing patients with suspected lung fibrosis to provide a diagnostic subtype classification, potentially facilitating proper treatments at an earlier stage of the disease process,” said Joshua Reicher, MD, co-founder and CEO of IMVARIA. “The FDA’s authorization of Fibresolve marks a significant milestone, not only for lung fibrosis patients, but also for the advancement of AI-based health care technologies. The medical community, along with health insurance companies, now has a viable, cost-effective option making AI highly practical, useful and easy to incorporate into medical practice for the thousands of pulmonologists who treat patients with lung disease.”

According to IMVARIA, Fibresolve is less intrusive and easier to use than other similar diagnostic tools. Data from patients with suspected interstitial lung disease are run through the AI-trained algorithm to deliver unintrusive, supplementary information that helps drive diagnosis. IMVARIA said it expects Fibresolve to not only benefit patient health, but also to be more cost efficient and less of a burden on the health care system.

“For people living with the rapidly deteriorating symptoms of this rare, yet deadly disease, the FDA authorization of Fibresolve offers real hope, while giving doctors who treat these patients a new, powerful tool that is designed to save lives and reduce suffering at an exponential rate that only AI can deliver,” said Michael Muelly, MD, co-founder and CTO of IMVARIA.

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