OneMedNet's RWD Supports FDA Clearance for AI-Powered ICH Detection Software
ByAinvest
Thursday, Jan 22, 2026 9:10 am ET1min read
ONMD--
OneMedNet Corporation, a provider of regulatory-grade Real-World Data, announced that its high-quality clinical data supported mlHealth 360 in obtaining FDA 510(k) clearance for Scaida BrainCT-ICH, an AI-powered software solution for detecting intracranial hemorrhage from head CT scans. The software analyzes CT images to identify suspected ICH in approximately 5.97 seconds, enabling faster clinical triage and decision-making. OneMedNet's regulatory-grade data played a critical role in model development.
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