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. – 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.”
