Ceribell wins FDA clearance for quantitative EEG trending software

Ceribell said Wednesday the FDA cleared new software for the Ceribell System that turns hours of complex EEG into bedside trends so clinicians can spot meaningful brain-activity changes sooner.

ICU EEG dumps hours of hard-to-read waveforms while minutes matter. Ceribell is putting FDA-cleared trend views (including neonatal aEEG) on the same portable AI EEG system so bedside teams can see change without waiting on a full read.

On Wednesday, 30 September 2026, CeriBell, Inc. said the U.S. Food and Drug Administration cleared new software for the Ceribell System. The company trades on Nasdaq as CBLL and uses Ceribell as its public name. It describes itself as a medical technology company focused on diagnosing and managing patients with serious neurological conditions. Neurological means the brain and the nerves. GlobeNewswire carried the release at 7:00 a.m. Eastern. The dateline is Sunnyvale, California. The subhead says the clearance is meant to make bedside EEG interpretation simpler and to support more informed care decisions for patients of all ages, across more than one use. Those lines are Ceribell’s.

The headline calls the decision a 510(k) clearance. On that path, the FDA clears a device when the maker shows it is substantially equivalent to a device already allowed on the market. It is a device clearance. It is not a drug approval. The release says the software makes it easier and faster for a clinician to interpret longitudinal brain activity and to make an appropriate clinical decision. Longitudinal means the recording across time, not one snapshot. Those lines are Ceribell’s.

EEG is electroencephalography. Sensors on the scalp record the brain’s electrical activity. Ceribell says that kind of monitoring can run for hours and can be hard to read in time. The company says the new software takes that raw recording and turns it into simple, easy-to-read trends at the bedside, so a clinician can spot a meaningful change sooner, when every minute matters. A trend, here, is a line that shows change over hours, instead of the full raw tracing. Those lines are Ceribell’s.

The software update adds three capabilities to what Ceribell calls the Ceribell Platform. The first is Alpha-Delta Ratio and Relative Alpha trending, which the company shortens to ADR and RA. Alpha and delta are names for bands in the brain’s electrical rhythm. Ceribell says the trends are continuous monitoring that can help catch early signs of brain distress and reduced blood flow in high-risk patients. The example the company gives is aneurysmal subarachnoid hemorrhage, a bleed around the brain after a weakened vessel bursts. Ceribell shortens that to SAH. The company says that monitoring is there to enable proactive intervention. Those lines are Ceribell’s.

The second capability is Burst Suppression monitoring, shortened to BS. Burst suppression is an EEG pattern of quiet stretches alternating with bursts of activity, the pattern teams watch during deep sedation. Ceribell says the feature gives a clear, real-time picture of brain activity that can be used to help clinicians safely fine-tune sedation drugs. The uses the company names are severe, ongoing seizures and controlling brain swelling. Those lines are Ceribell’s.

The third is Amplitude-Integrated EEG, shortened to aEEG. It compresses a long recording into a simpler view of the brain’s background activity, so a team can scan hours without reading every raw line. Ceribell says it brings standard-of-care neonatal assessment into the NICU, the intensive care unit for newborns, and that the same view complements monitoring of adults in an ICU. Neonatal means a newborn. Standard of care, in that sentence, is Ceribell’s phrase for an assessment a NICU already treats as expected. Those lines are Ceribell’s.

The clearance has no age restriction. Ceribell says the same easy-to-use trends are available whether the patient is a premature newborn in the NICU or an adult in the emergency department or the ICU. A premature newborn is a baby born early. Those lines are Ceribell’s.

Jane Chao, Ph.D., co-founder and chief executive of Ceribell, said: “In critical care, time is brain, and every hour spent waiting for interpretation of EEG is time lost delivering treatment at the bedside.” She said the company expects to add the features with an automatic software update in the first half of 2027. Expects is the company’s word. The release says statements about the benefits of the technology, and about how the platform keeps evolving, are forward-looking. They can turn out differently. They are not an outcome figure the FDA published with the clearance. That quotation, and that timing, are Ceribell’s.

Ceribell says these algorithms build on recent clearances for neonatal seizure detection and for delirium monitoring on its AI-powered EEG platform. Delirium is a sudden state of confusion, often in a very sick adult. Acute care, the setting the company names, is hospital care for a sudden or serious illness. The company says the updates are meant to make fuller brain monitoring available to more patients, whatever their age or the unit they are in. The about box says the Ceribell System is a point-of-care EEG platform for acute care: portable hardware that can be put on quickly, plus AI algorithms, for a fast diagnosis and for continuous monitoring. Point of care means at the bedside, rather than in a separate EEG lab. Ceribell is based in Sunnyvale, California. The release names Brian Johnston at Gilmartin Group for investors and Laura Hartlieb for press. It does not print a price, a hospital customer count, or a measured change in patient outcomes.

The product page describes the system this software is for. Ceribell calls the wearable EEG a frontline tool for continuous monitoring. The page says setup can be done within minutes with minimal training. It says the system offers bedside alerts for continuous seizures and streams the EEG so neurology can review it in real time. With Clarity, the company’s AI layer, the page says the system offers round-the-clock monitoring and alerts for continuous seizures and for suspected status epilepticus, a seizure that does not stop. The page says that bedside alert was the first the FDA cleared for suspected status epilepticus in adults and for continuous seizures in neonates and pediatric patients. A neonate is a newborn. Pediatric means a child. A cloud portal, the page says, lets a physician review the recording from anywhere, with labels through the recording and a seizure-burden trend, a line for how much of the recording is seizure. Those lines are on the product page. They describe the system already being offered. They are not a description of the three trends cleared on Wednesday.

In plain terms, Ceribell said on Wednesday that the FDA cleared three bedside views for the Ceribell System: alpha-delta and relative-alpha trends, burst-suppression monitoring, and amplitude-integrated EEG. There is no age limit. The same trends are for a premature newborn and for an adult in the emergency department or the ICU. The company expects an automatic software update in the first half of 2027. The lines about catching distress earlier, and about fine-tuning sedation safely, are Ceribell’s.

The picture is Ceribell’s diagram of the Ceribell System, from the company’s point-of-care EEG page. It shows an EEG headband, a neonatal headcap, a pocket recorder whose screen reads that continuous seizures are suspected, a cloud link for a real-time EEG display, a Clarity AI chart, and a desktop portal of EEG waveforms. It is a diagram of the hardware and software on that page. It is not a screenshot of the trends cleared on Wednesday, and it does not print a date.