IMVARIA has received FDA 510(k) clearance for ScreenDx, the first AI-powered screening algorithm designed to assess the risk of Interstitial Lung Disease (ILD) using existing CT scans. This clearance marks a major step in improving early detection and diagnosis of ILD, enabling clinicians to identify at-risk patients sooner and enhance treatment outcomes. IMVARIA is a 2021 Rosenman Innovator.

From the press release:

“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.”