IMVARIA announces FDA De Novo marketing authorization of Fibresolve

Jan. 17, 2024
AI-based diagnostic tool with integrated billing codes.

IMVARIA Inc. announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the use of Fibresolve, a digital biomarker that uses artificial intelligence (AI) to guide safe, non-invasive diagnosis of lung fibrosis with a focus on idiopathic pulmonary fibrosis (IPF).  

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 non-invasive adjunct information, a diagnostic subtype classification, helping drive diagnosis and setting the patient on a pathway to be given an appropriate treatment on a more timely basis. In addition to the health benefits, this is expected to save thousands of dollars per person for each test, with the cost savings going back into the health system. 

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