Medical Device Network

IMVARIA bags FDA authorisation for AI lung fibrosis diagnostic

Fibresolve is the first AI-powered diagnostic tool with billing codes recognised by the AMA, reported by the company.

The US Food and Drug Administration (FDA) has given the green light to US-based IMVARIA for its lead product Fibresolve, an artificial intelligence (AI)-based lung fibrosis biomarker.

The AI-driven tool helps to diagnose lung fibrosis, particularly idiopathic pulmonary fibrosis (IPF), a severe form of the disease.

The technology analyses lung computed tomography (CT) imaging data to categorise suspected cases of interstitial lung disease (ILD). It enhances the standard care process by employing machine learning pattern recognition to deliver a diagnostic classification output based on imaging findings.

The company has obtained CPT billing codes from the American Medical Association (AMA), enabling former billing for its diagnostic use in lung fibrosis. This recognition streamlines financial processes, enhancing the products integration into healthcare systems.

In the announcement accompanying the approval, CEO of IMVARIA Joshua Reicher said: “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.”

According to a report on GlobalData’s Pharma Intelligence Center, the IPF market across the 7MM (US, France, Germany, Italy, Spain, UK, and Japan) was worth $2.4bn in 2019, and is forecast to grow at a compound annual growth rate (CAGR) of 5.3% to $4bn by 2029. GlobalData has identified a high unmet clinical need in IPF, especially surrounding the challenges of diagnosis.

In September last year, Brainomix and TIPAL teamed up to assess its AI-powered diagnostic tool for IPF, undertaking a sub-study to evaluate the efficacy of the platform. The e-lung platform aims to standardise the quantification of lung fibrosis on high resolution CT scans to detect progressive fibrosis.

Earlier this month, Swedish-based Alex Therapeutics announced that its clinical trial of cognitive behavioural therapy (CBT) delivered via an app for the treatment of anxiety in patients with lung fibrosis met its primary endpoint. Data from the trial highlighted that it reduced anxiety in patients living with pulmonary fibrosis, of which there is no cure, using a nine-week course of cognitive therapy.