OneMedNet Corporation (Nasdaq: ONMD), a leading provider of regulatory-grade, AI-ready Real-World Data (RWD), announced that its high-quality, multimodal clinical data played a key role in supporting mlHealth 360’s successful U.S. Food and Drug Administration (FDA) 510(k) clearance of Scaida BrainCT-ICH, an AI-powered software designed to rapidly detect intracranial hemorrhage (ICH) from head CT scans. The software analyzes head CT images and identifies suspected ICH in about 5.97 seconds after image acquisition, enabling faster clinical triage and timely decision-making in emergency and acute care settings. OneMedNet’s regulatory-grade RWD—drawn from longitudinal electronic medical records (EMR), diagnostic imaging, and clinical reports—was instrumental in the development, validation, and regulatory submission of the AI model. The data’s depth, diversity, and compliance with regulatory standards allowed mlHealth 360 to access fit-for-purpose datasets without compromising data integrity or meeting stringent regulatory requirements. Aaron Green, CEO and President of OneMedNet, said the milestone underscores the company’s growing role as a trusted partner in AI and life sciences innovation. “Seeing our regulatory-grade Real-World Data contribute directly to an FDA-cleared solution reinforces the value of high-quality data in accelerating meaningful innovation,” Green stated. “This collaboration highlights our mission to responsibly unlock healthcare data and enable partners to deliver better outcomes at scale.” Kumar Surender Sinwar, CEO of mlHealth 360, emphasized the importance of data quality and compliance in their development process. “Partnering with OneMedNet was the right decision from the start,” Sinwar said. “Their ability to provide immediate access to high-quality, regulatory-grade imaging and clinical data allowed us to focus on building and validating our AI without concerns about data completeness, quality, or compliance—critical factors in achieving FDA clearance.” The FDA clearance of Scaida BrainCT-ICH highlights the increasing importance of Real-World Data in advancing AI-driven medical technologies, particularly in time-sensitive areas like stroke and trauma care. For OneMedNet, this achievement further validates its iRWD™ platform, which aggregates data from over 2,130 healthcare sites across specialties including oncology, cardiology, and rare diseases. Beyond healthcare, OneMedNet’s proprietary AI enables data anonymization for industries such as finance, retail, and telecommunications, supporting secure data sharing and system testing while protecting privacy. The success of Scaida BrainCT-ICH demonstrates a strong link between high-quality, compliant data and successful regulatory outcomes—reinforcing growing demand from both new and repeat customers in the life sciences and AI sectors.