IMVARIA Receives 510(k) Clearance for ScreenDx, a First-of-its-Kind Screening Algorithm to Assess for Interstitial Lung Disease

IMVARIA’s ScreenDx enhances referral pathways by automatically assessing medical data for interstitial lung findings compatible with interstitial lung disease (ILD)

BERKELEY, Calif.--(BUSINESS WIRE)--IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced its second FDA authorization, securing 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ScreenDx solution, an AI-powered healthcare tool to assist clinicians in assessing for interstitial lung disease (ILD).

“ScreenDx is a software‐only device leveraging artificial intelligence to analyze CT imaging data for findings suggestive of interstitial lung disease,” said Joshua Reicher, MD, Co-founder and CEO of IMVARIA. “ScreenDx is designed to be supplementary for current standard-of‐care workflows, providing adjunctive information based on pattern recognition, as part of a referral pathway to an appropriate, qualified clinician. This FDA clearance marks another major milestone for IMVARIA, continuing the advancement of AI-based healthcare technologies.”

Patients with ILD suffer from frequent diagnostic delays and often undergo multiple clinical and radiological assessments before getting diagnosed. ScreenDx was developed by IMVARIA to augment referral pathways by automatically assessing for interstitial lung findings compatible with interstitial lung disease, helping flag this deadly disease in a wide range of settings. It is intended as an incidental screening tool to set patients on a path to be given an appropriate diagnosis and treatment on a timely basis.

“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,” said Michael Muelly, MD, Co-founder and CTO of IMVARIA. “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 specialty clinical settings. As medical doctors ourselves leading IMVARIA, we are putting another powerful tool into the hands of clinicians to help enhance decision-making.”

This regulatory milestone builds on IMVARIA’s success last year with the FDA’s authorization of IMVARIA’s Fibresolve, an adjunctive diagnostic solution that uses AI to guide safe, non-invasive diagnosis of idiopathic pulmonary fibrosis (IPF). In early 2024, this signified the first ever FDA authorization of a diagnostic tool of any type in lung fibrosis, and the first FDA Breakthrough-Designated AI diagnostic tool with simultaneously adopted CPT billing codes by the American Medical Association (AMA) in any disease.

In the United States, interstitial lung disease affects approximately 650,000 people and causes between 25,000 and 30,000 deaths every year, according to the JAMA Network. ILD is a type of lung condition that causes inflammation or fibrosis in lung tissue, characterized by shortness of breath and difficulty getting enough oxygen into the bloodstream. ILD is complex, as it can have many causes and vary in treatments. In some cases, ILD can eventually lead to a patient’s need for a lung transplant, if not detected in an early stage and not treated early enough. With ScreenDx helping assess for ILD, and Fibresolve serving as a diagnostic adjunct in IPF, IMVARIA is driving care forward for patients with diffuse lung disease.

IMVARIA’s leadership team will be meeting with investors and partners at the 43rd Annual J.P. Morgan Healthcare Conference, which is taking place on January 13-16, 2025 in San Francisco, CA.

For more information about IMVARIA, click here.

About IMVARIA Inc.

IMVARIA is a health tech company pioneering AI-driven solutions that empower clinicians to make accurate diagnoses and prognoses at earlier stages of disease and reduce the need for invasive biopsy testing. Founded in 2019 by physician-engineers from Google and Stanford University, the company operates its AI Lab with automated, machine-learning algorithm technology to transform clinical decision-making into data science. IMVARIA is based in Berkeley, CA. For more information, go to www.imvaria.com.

ScreenDx Use

ScreenDx is a software‐only device that receives and analyzes lung computed tomography (CT) imaging data in order to assess for interstitial lung findings compatible with interstitial lung disease. The device supplements the standard-of‐care workflow by providing a qualitative output of imaging findings based on pattern recognition, in order to provide adjunctive information as part of a referral pathway to an appropriate qualified clinician. Patients with positively identified patterns may undergo assessment for lung fibrosis, but ScreenDx does not replace the current standard of care methods for diagnosis of lung fibrosis and the results of the device are not intended to rule-out or rule-in lung fibrosis. The results of ScreenDx are intended to be used only by clinicians qualified in the care of lung disease, in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.