OneMedNet shares rise 13.57% premarket after real-world data supports FDA 510(k) clearance for AI-powered brain bleed detection tool.

OneMedNet surged 13.57% in premarket trading following the announcement that its regulatory-grade 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 milestone underscores OneMedNet’s role as a trusted data partner for AI and life-sciences innovation, with its multimodal clinical datasets enabling rapid regulatory submissions. The clearance highlights the growing demand for high-quality data in medical AI, particularly for time-sensitive applications like stroke care, reinforcing investor confidence in OneMedNet’s market differentiation and long-term growth potential.