ASA Monitor April 2024, Vol. 88, 14.
AI digital biomarker for lung fibrosis diagnosis
Imvaria Inc. has gained FDA approval for Fibresolve, an AI-driven digital biomarker solution facilitating noninvasive diagnosis of lung fibrosis, notably idiopathic pulmonary fibrosis (IPF). Lung fibrosis is a life-threatening disease, with IPF being particularly devastating. Current therapies are expensive and potentially toxic for some patients. Diagnosis of the condition can take 2.5 years on average, putting patients at risk for severe lung impairment and even death after symptoms appear and before diagnosis. This approval marks the first FDA authorization for a diagnostic tool in lung fibrosis and the first Breakthrough-Designated AI diagnostic tool with AMA-adopted billing codes in any disease. The digital biomarker uses AI algorithms on lung CT imaging data for noninvasive diagnosis, serving as an adjunct for clinicians by providing diagnostic subtype classifications. This AI-driven technology could improve patient outcomes and reduce suffering by enabling earlier treatment and providing a cost-effective option for pulmonologists.
Source: asamonitor.pub/4bj5Jd3