Sam Brusco, Associate Editor01.16.24
IMVARIA has earned U.S. Food and Drug Administration (FDA) de novo clearance for Fibresolve, a digital biomarker that uses artificial intelligence (AI) for non-invasive diagnosis of lung fibrosis, with focus on idiopathic pulmonary fibrosis (IPF).
The company said Fibresolve, as a billable diagnostic tool , can expedite access to a non-invasive diagnostic solution using digital biomarkers in a novel way for lung fibrosis. The solution was previously awarded breakthrough status by the FDA, as well.
As an option before other, more invasive options, data from patients with suspected interstitial lung disease is run through the company’s AI-trained algorithm for non-invasive adjunct information, a diagnostic subtype classification, helping drive diagnosis and timely treatment. IMVARIA said Fibresolve is expected to save thousands of dollars per person for each test.
“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 healthcare 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.”
The company said Fibresolve, as a billable diagnostic tool , can expedite access to a non-invasive diagnostic solution using digital biomarkers in a novel way for lung fibrosis. The solution was previously awarded breakthrough status by the FDA, as well.
As an option before other, more invasive options, data from patients with suspected interstitial lung disease is run through the company’s AI-trained algorithm for non-invasive adjunct information, a diagnostic subtype classification, helping drive diagnosis and timely treatment. IMVARIA said Fibresolve is expected to save thousands of dollars per person for each test.
“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 healthcare 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.”