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Ceribell clears three EEG algorithms under K261712 with no age limit

MedDevice Startups Staff · just now · 2 min read · Via Ceribell (GlobeNewswire)

FDA cleared a software update to the Ceribell System on September 30 under K261712. The update adds alpha-delta ratio and relative alpha trending, burst suppression monitoring for sedation management, and amplitude-integrated EEG for longer-run background activity.

The labeling carries no age restriction, which puts premature neonates and adult ICU patients under one clearance. Ceribell already holds authorizations for neonatal seizure detection and delirium monitoring. The algorithms reach installed recorders as an automatic update in the first half of 2027.

Getting the full age range in one submission is the cheaper path when the algorithm does not change by patient size, and it saves a second predicate argument later. Ceribell (Nasdaq: CBLL) is based in Sunnyvale, California, and has about 327 employees.

Questions & Answers

What did Ceribell get FDA clearance for in September 2026?

On September 30, 2026, FDA cleared a Ceribell System software update under K261712. It adds alpha-delta ratio and relative alpha trending, burst suppression monitoring, and amplitude-integrated EEG analysis.

Does the Ceribell K261712 clearance have an age restriction?

No. The K261712 clearance for the Ceribell System carries no age restriction, so the software covers premature neonates through adult ICU patients.

When will the new Ceribell EEG algorithms reach hospitals?

Ceribell expects the K261712 algorithms to reach installed systems as an automatic software update in the first half of 2027.

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