IMVARIA has gained 510(k) clearance from the US Food and Drug Administration (FDA) for its AI-powered healthcare tool, ScreenDx, designed to help clinicians in interstitial lung disease (ILD) assessment.
This clearance marks the receipt of second authorisation for the company from the US regulator.
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Developed by the company, ScreenDx claims to increase referral pathways by “automatically assessing” interstitial lung findings compatible with ILD. The tool aims to help “flag” the disease in a broad range of settings.
It operates as a “software-only” device that “analyses” lung computed tomography (CT) imaging data to identify findings consistent with ILD. It provides qualitative imaging results based on pattern recognition, offering additional information as part of a referral pathway to qualified clinicians.
IMVARIA co-founder and CTO Michael Muelly said: “With the FDA 510(k) clearance of our ScreenDx digital solution, IMVARIA continues on the quest to make AI highly practical, useful, and easy to incorporate into medical practice for the thousands of pulmonologists who treat patients with lung diseases.
“Our ultimate goal is to help patients with serious diseases, like ILD, get identified and placed into the diagnostic pathway as efficiently as possible, regardless of whether they were first seen in emergency, lung cancer screening, or speciality clinical settings.”
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By GlobalDataThe FDA’s authorisation of ScreenDx builds upon the company’s prior achievement with Fibresolve, an adjunctive AI tool for the non-invasive diagnosis of idiopathic pulmonary fibrosis (IPF).
Last year, Fibresolve became the first FDA-authorised diagnostic tool for lung fibrosis and the first FDA breakthrough-designated tool to have Current Procedural Terminology (CPT) billing codes concurrently adopted by the American Medical Association (AMA) for any disease.
ILD causes inflammation or fibrosis in lung tissue, leading to shortness of breath and difficulty in oxygenating the bloodstream.
Founded in 2019 by Google and Stanford University’s physician-engineers, IMVARIA operates an AI Lab leveraging automated, machine-learning algorithm technology.
