FDA Clears AI-Powered CT Assessment Tool for Lung Fibrosis

While the diagnosis of lung fibrosis currently may not occur up to two and a half years after initial symptoms, the Food and Drug Administration (FDA) has granted De Novo clearance to Fibresolve, an emerging artificial intelligence (AI)-enabled software that may facilitate earlier diagnosis and timely treatment.

Utilizing machine learning pattern recognition to assess lung computed tomography (CT) scans, Fibresolve may facilitate the diagnosis of lung fibrosis and possibly idiopathic pulmonary fibrosis (IPF), according to Imvaria, the developer of Fibresolve. The company added that Fibresolve can provide subtype classification in cases involving suspected interstitial lung disease (ILD).

The capability of Fibresolve to provide adjunctive qualitative classification of CT imaging findings previously garnered Breakthrough Device Designation from the FDA. Imvaria noted the software also has established CPT billing codes.

“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, M.D., 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.”