Ceribell received FDA 510(k) clearance (K261712) for software that adds Alpha Delta Ratio and Relative Alpha trending, burst suppression monitoring and amplitude integrated EEG to its point of care EEG system. The clearance carries no age restriction, so the same trends apply from premature newborns in the NICU to adults in the ICU and emergency department. Ceribell expects to deliver the features through an automatic software update in the first half of 2027.
Our readOne system across neonatal and adult critical care simplifies training and purchasing for hospitals that run both. The features are cleared but not yet shipping, so they belong in 2027 plans rather than this year's.