Ceribell Wins FDA Clearance for New EEG Monitoring Software; Shares Slip in Pre-Market

Ceribell Inc. (CBLL) said the FDA cleared new software for its Ceribell System that converts EEG brain-activity data into simplified trends for faster bedside interpretation. The clearance carries no age restriction, allowing use across neonatal, emergency and intensive-care settings. The update adds three features: Alpha-Delta Ratio and Relative Alpha trending to flag brain distress and reduced blood flow in high-risk patients including those with aneurysmal subarachnoid hemorrhage; Burst Suppression monitoring for real-time sedation adjustment during severe seizures or brain swelling; and Amplitude-Integrated EEG for longer-term background monitoring, including newborns in NICUs. Ceribell expects to deliver the features via automatic software update in the first half of 2027, building on its AI-powered EEG platform. CBLL closed at $24.86 on September 29, 2026, up 1.43%, and traded at $24.58 pre-market, down 1.12%. The stock has ranged between $10.85 and $25.63 over the past year.