Summary:
IMVARIA Inc a leading health tech company specializing in AI-driven digital biomarker solutions, has received marketing authorization from the U.S. Food and Drug Administration (FDA) for Fibresolve. This digital biomarker solution utilizes artificial intelligence (AI) to guide a safe, non-invasive diagnosis of lung fibrosis, with a specific focus on idiopathic pulmonary fibrosis (IPF). This marks the first-ever FDA authorization for a diagnostic tool related to lung fibrosis and is also the first FDA Breakthrough-Designated AI diagnostic tool to receive simultaneously adopted CPT billing codes by the American Medical Association (AMA) in any disease.
The technology analyses lung computed tomography (CT) imaging data to categorise suspected cases of interstitial lung disease (ILD). It enhances the standard care process by employing machine learning pattern recognition to deliver a diagnostic classification output based on imaging findings. Fibresolve serves as an invaluable adjunct to clinicians, aiding in the assessment of patients with suspected lung fibrosis by providing a diagnostic subtype classification. This classification has the potential to facilitate the initiation of proper treatments at an earlier stage of the disease process.
Lung fibrosis encompasses a life-threatening group of diseases affecting hundreds of thousands of people annually, with IPF being particularly devastating. Traditionally, existing therapies for this condition are costly and, if administered to the wrong patients, could be potentially toxic. The delay in diagnosis averages nearly two-and-a-half years from the initial symptoms, while severe lung impairment and mortality can occur within one to two years from the onset of lung fibrosis.
IMVARIA’s Fibresolve is positioned as a groundbreaking innovation that meets stringent regulatory requirements, promising to improve outcomes for patients. The FDA’s authorization of Fibresolve as a billable digital diagnostic tool for clinicians is expected to expedite access to a non-invasive diagnostic solution using digital biomarkers, revolutionizing the diagnosis and treatment of lung fibrosis.
Article written by Biospace| Image by iStock
16/01/2024
Source:
Biospace
https://www.biospace.com/article/releases/imvaria-announces-fda-de-novo-marketing-authorization-of-fibresolve-an-ai-biomarker-in-lung-fibrosis-and-the-adoption-of-novel-cpt-billing-codes-by-the-american-medical-association/