The artificial intelligence developer Imvaria has claimed a de novo clearance from the FDA for a digital diagnostic that analyzes chest CT scans for the signs of idiopathic pulmonary fibrosis. According to the Berkeley, California-based startup, the green light for its Fibresolve program marks the agency’s first for a specialized diagnostic tool in any type of lung fibrosis. It aims to help distinguish idiopathic pulmonary fibrosis from other interstitial lung diseases, ahead of any invasive tissue biopsy procedure.
FDA grants first clearance to AI program for diagnosing idiopathic pulmonary fibrosis
