Ceribell Receives FDA 510(k) Clearance for Quantitative EEG Trending and Amplitude-Integrated EEG Analysis
Key Highlights
- ➤FDA clears Ceribell (CBLL) software for quantitative EEG trending and aEEG analysis
- ➤Software adds Alpha-Delta Ratio and Relative Alpha brain-activity trending
- ➤Burst Suppression monitoring enables real-time sedation management during severe seizures
- ➤Software update expected through automatic rollout in first half of 2027
Expert Statements
Jane Chao, Co-founder and CEO of Ceribell
“In critical care, time is brain, and every hour spent waiting for interpretation of EEG is time lost delivering treatment at the bedside”
Jane Chao, Co-founder and CEO of Ceribell
“We expect to integrate these new features through an automatic software update in the first half of 2027”
SUNNYVALE, Calif., Sept. 30, 2026 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell” or the “Company”), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced that the U.S. Food and Drug Administration (FDA) has cleared new software for the Ceribell System that makes it easier and faster for clinicians to interpret longitudinal brain activity and make appropriate clinical decisions.(1)
Brain monitoring with electroencephalography (EEG) can generate hours of complex data that can be difficult to interpret in a timely manner. Ceribell's newly cleared software takes that raw information and turns it into simple, easy-to-read trends at the bedside, so clinicians can spot meaningful changes in brain activity sooner when every minute matters.
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