OneMedNet Rises After MLHealth 360 Secures FDA Clearance for Scaida BrainCT-ICH

OneMedNet Inc. shares surged following news that its partner MLHealth 360 received FDA clearance for the Scaida BrainCT-ICH, a machine learning-based diagnostic tool for intracerebral hemorrhage detection. The approval, announced January 22, 2026, marks a key milestone in advancing AI-powered neuroimaging solutions. The Scaida BrainCT-ICH system uses artificial intelligence to analyze brain CT scans and identify signs of bleeding with high accuracy, aiming to reduce diagnosis time in emergency settings. MLHealth 360, a subsidiary of OneMedNet, developed the technology under a strategic collaboration focused on digital health innovation. The FDA’s 510(k) clearance allows the device to be marketed in the U.S. as a Class II medical device. OneMedNet’s stock climbed 18% in after-hours trading, reflecting investor optimism over commercialization potential. The company expects initial deployment in hospital radiology departments by mid-2026.