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. 

“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,” Imvaria’s co-founder and CEO, Joshua Reicher, said in a statement. “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.”

Alongside the agency’s clearance, Imvaria also simultaneously obtained CPT billing codes from the American Medical Association, a major step toward receiving coverage and reimbursement.

“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,” Reicher said.

The machine learning-powered Fibresolve classifier had previously received a breakthrough designation from the FDA.

According to a previous company study, the early use of Fibresolve was able to reduce the number of lung biopsies within a health system by 41%, and it also saved money by directing patients who needed treatment the most to today’s costly fibrosis therapies.

Late last year, Imvaria announced that it signed an agreement with the Mayo Clinic to develop AI programs for analyzing cases of lung cancer, with the startup’s engineers tapping into the institution’s massive health data archives. Imvaria first made its debut in 2019, launched by a team of developers from Google and Stanford University.