OneMedNet shares surge 10.48% intraday after real-world data supports FDA 510(k) clearance for mlHealth 360’s AI brain bleed detection software.

OneMedNet surged 10.48% intraday following the announcement that its real-world data supported mlHealth 360 in securing FDA 510(k) clearance for Scaida BrainCT-ICH, an AI-powered tool for detecting intracranial hemorrhage. The clearance validates OneMedNet’s role as a provider of regulatory-grade data critical for AI-driven medical innovations. The company highlighted that its multimodal datasets enabled rapid development and validation of the software, which identifies suspected bleeding in under six seconds, enhancing clinical triage. CEO statements underscored the partnership’s significance in advancing patient care and reinforcing OneMedNet’s value proposition in healthcare data solutions. The milestone aligns with recent strategic gains, including network expansion and AI platform integration, bolstering investor confidence in its growth trajectory.