IMVARIA’s ScreenDx enhances referral pathways by automatically assessing medical data for interstitial lung findings compatible with interstitial lung disease (ILD)
Berkeley, Calif. – January 13, 2025 − 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.”