On September 30, 2026, Ceribell announced FDA 510(k) clearance for new software on its Ceribell System, designed to make it easier for clinicians to review changes in brain activity over time.
The update adds three EEG analysis tools:
Alpha-Delta Ratio and Relative Alpha trending, burst-suppression monitoring, and amplitude-integrated EEG (aEEG).
Ceribell says the features may help clinicians monitor brain distress or reduced blood flow, visualize brain activity while adjusting sedation, and track background activity in neonatal and adult critical-care settings.
The clearance has no age restriction, according to the announcement. Ceribell expects to deliver the features through an automatic software update in the first half of 2027.
Sources:
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