FDA grants first clearance to AI program for diagnosing idiopathic pulmonary fibrosis
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.
