OneMedNet Real-World Data Supports FDA 510(k) Clearance of AI-Powered Scaida BrainCT-ICH Software

Core Insights - OneMedNet Corporation has announced that its Real-World Data (RWD) has supported mlHealth 360 in obtaining FDA 510(k) clearance for Scaida BrainCT-ICH, an AI-powered software for detecting intracranial hemorrhage from CT scans [1][4] Group 1: Company Overview - OneMedNet is a leading provider of regulatory-grade, AI-ready Real-World Data, utilizing over 2,130 healthcare sites through its iRWD™ platform [6] - The company focuses on delivering high-quality data that fuels innovation in drug development, medical devices, and AI applications [6] - OneMedNet's data includes longitudinal electronic medical records, diagnostic imaging, and clinical reports, which are crucial for regulatory submissions [3][4] Group 2: Product and Technology - Scaida BrainCT-ICH uses AI to analyze head CT images, identifying suspected intracranial hemorrhage in approximately 5.97 seconds, enhancing clinical triage and decision-making [2] - The FDA clearance of Scaida BrainCT-ICH underscores the increasing importance of Real-World Data in advancing medical AI, particularly in urgent clinical scenarios [5] Group 3: Partnerships and Collaborations - OneMedNet collaborates with mlHealth 360, providing high-quality, regulatory-grade data that allows the latter to focus on AI development without concerns about data quality or compliance [5] - The partnership highlights the value of high-quality data in accelerating healthcare innovations and improving patient outcomes [5][8] Group 4: Industry Impact - The milestone achieved by OneMedNet reinforces its position as a trusted data partner for life sciences and AI companies, indicating a growing reliance on high-quality data for successful regulatory outcomes [4][5] - The collaboration between OneMedNet and mlHealth 360 exemplifies the potential of AI in transforming medical imaging and enhancing clinical workflows [8][9]