OneMedNet Says Its Multimodal Clinical Data Supports mlHealth 360 In Obtaining FDA 510(K) Clearance For Scaida BrainCT-ICH Software

OneMedNet Corporation (NASDAQ:ONMD), a leading provider of regulatory-grade, AI-ready Real-World Data (RWD), today announced that its high-quality, multimodal clinical data supported mlHealth 360 in obtaining U.S. Food and Drug Administration (FDA) 510(k) clearance for Scaida BrainCT-ICH, an AI-powered software solution designed to facilitate the rapid detection of intracranial hemorrhage (ICH) from head computed tomography (CT) scans.

Scaida BrainCT-ICH leverages artificial intelligence to analyze head CT images and identify suspected intracranial hemorrhage in approximately 5.97 seconds after image acquisition, enabling faster clinical triage and supporting timely decision-making in acute care settings, according to mlHealth 360.