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

BERKELEY, Calif.–(BUSINESS WIRE)– #510k–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 inte
BERKELEY, Calif.–(BUSINESS WIRE)– #510k–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 inte
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