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OneMedNet Real-World Data Supports FDA 510(k) Clearance of AI-Powered Scaida BrainCT-ICH Software
Globenewswire· 2026-01-22 14:00
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]
OneMedNet Welcomes Our Latest Subscriber mlHealth360
Globenewswire· 2025-10-20 12:45
Core Insights - OneMedNet Corporation has been selected by mlHealth360 as its Real-World Data provider, marking a significant milestone in the expansion of OneMedNet's subscription-based business model [1][2][3] Company Overview - OneMedNet is a leader in AI-powered Real-World Data (RWD), utilizing data from over 1,750 healthcare provider sites and 131 million+ clinical studies to support healthcare innovation [1][4] - The company’s iRWD™ platform provides regulatory-grade, de-identified imaging and clinical data, which is crucial for AI model development and validation [2][4] Partnership Details - The multi-year agreement with mlHealth360 allows continuous access to curated X-Ray and CT datasets, enhancing mlHealth360's capabilities in medical imaging [2][3] - The collaboration aims to improve patient care by providing high-quality medical imaging data, which is essential for advancing AI model development [3][6] Market Demand - There is a growing market demand for high-quality, multimodal Real-World Data that supports model training and regulatory-grade validation, highlighting the importance of partnerships with AI and analytics companies [3][4]