Ceribell Receives FDA 510(k) Clearance for Quantitative EEG Trending and Amplitude-Integrated EEG Analysis

The clearance extends the new monitoring capabilities across age groups, from premature newborns to adult patients.

Rhea-AI Summary

Ceribell (CBLL) received FDA 510(k) clearance for new software that adds quantitative brain-activity trending and amplitude-integrated analysis to its monitoring system.

The clearance has no age restriction, covering premature newborns as well as adults. The software will add three capabilities: Alpha-Delta Ratio and Relative Alpha trending, which can help identify signs of brain distress and reduced blood flow; burst suppression monitoring, which can help guide sedation adjustments; and amplitude-integrated electroencephalography (EEG), a simplified view of brain electrical activity over time. The latter supports neonatal assessment and complements adult intensive-care monitoring.

Ceribell expects to integrate the features through an automatic software update in the first half of 2027.

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Positive

• Moderate pointFDA 510(k) clearance authorizes new quantitative EEG trending and amplitude-integrated EEG analysis software.
• Minor pointNo age restriction allows the cleared capabilities to serve premature newborns and adult patients.
• Minor point. Forward-looking: it has not happened yet and may not happen.Automatic software update is expected to integrate the features in the first half of 2027.

Negative

• None.

Argus Sep 30 session

-1.93% close to close Open Argus

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News Market Reaction – CBLL

On Sep 30, the day this news came out, CBLL closed 1.93% below the previous close.

Data tracked by StockTitan Argus for the Sep 30 session.

Key Figures

Software capabilities: 3 capabilities Planned software update: First half of 2027

Software capabilities

3 capabilities

Added by the cleared software update

Planned software update

First half of 2027

Expected automatic integration of the new features

Historical Context

1 past event · Latest: Aug 10

1 event

1. Aug 10

   FDA clearance

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Key Terms

510(k) clearance, electroencephalography, burst suppression, amplitude-integrated eeg, +1 more

5 terms

510(k) clearance regulatory

"Ceribell Receives FDA 510(k) Clearance for Quantitative EEG Trending"

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

electroencephalography medical

"Brain monitoring with electroencephalography (EEG) can generate hours"

Electroencephalography is a medical test that uses small sensors on the scalp to record the brain’s electrical activity over time, like an EKG for the brain. Investors care because EEG data can be used in drug and device development, patient diagnosis, and monitoring treatment effects; strong EEG results can influence clinical success, regulatory approvals, and market adoption, affecting a company’s value and risk profile.

burst suppression medical

"Burst Suppression (BS) Monitoring: Provides a clear, real-time picture"

An electroencephalogram (EEG) pattern of alternating, brief periods of relatively high-amplitude electrical activity (bursts) and longer periods of very low or near-flatline activity (suppressions). It indicates profoundly reduced and intermittent cortical neuronal activity and is seen in deep anesthesia, severe brain injury, coma, hypothermia, or deliberately produced by potent sedative or anesthetic drugs to control refractory seizures. The pattern reflects synchronized neuronal firing during bursts separated by widespread neuronal silence and is distinct from a continuously isoelectric (flat) EEG.

amplitude-integrated eeg medical

"Amplitude-Integrated EEG (aEEG): Offers simplified, long-term monitoring"

Amplitude-integrated EEG (aEEG) is a simplified form of electroencephalography that records brain electrical activity over long periods, compresses and filters the raw signal, and displays it as a trend of the signal's amplitude on a time-compressed chart. It is commonly used at the bedside—especially in newborns and critically ill patients—to monitor overall brain function and detect patterns such as continuous background activity, suppression, seizures, or sleep–wake cycling; because it reduces detail compared with full EEG, it can miss brief or focal seizures and is often supplemented by conventional EEG for detailed diagnosis.

aneurysmal subarachnoid hemorrhage medical

"patients, such as those suffering from aneurysmal subarachnoid hemorrhage (SAH)"

Aneurysmal subarachnoid hemorrhage is bleeding into the thin space surrounding the brain caused when a weakened blood vessel balloon (an aneurysm) bursts. Like a burst pipe leaking into a narrow hallway, it can cause sudden, severe damage and often requires urgent surgery or devices and long hospital care. For investors, its frequency, treatment options, and outcomes influence demand for medical devices, drugs, hospital services, clinical trial results and health-care spending.

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New clearance to further simplify bedside EEG interpretation and enable more informed interventions for patients of all ages across multiple indications

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.

The software update will add three capabilities to the Ceribell Platform:

• Alpha-Delta Ratio (ADR) & Relative Alpha (RA) Trending: Delivers continuous brain monitoring which can be used to help catch early signs of brain distress and reduced blood flow in high-risk patients, such as those suffering from aneurysmal subarachnoid hemorrhage (SAH), enabling proactive intervention.
• Burst Suppression (BS) Monitoring: Provides a clear, real-time picture of brain activity that can be used to help clinicians safely fine-tune sedation drugs when treating severe, ongoing seizures or controlling brain swelling.
• Amplitude-Integrated EEG (aEEG): Offers simplified, long-term monitoring of background brain activity, bringing standard-of-care neonatal assessment to the NICU while complementing adult ICU monitoring.
  

Notably, this clearance carries no age restriction. The same easy-to-use trends are available whether the patient is a premature newborn in the NICU or an adult patient in the emergency department or ICU.

"In critical care, time is brain, and every hour spent waiting for interpretation of EEG is time lost delivering treatment at the bedside," said Jane Chao, Ph.D., co-founder and CEO of Ceribell. "We expect to integrate these new features through an automatic software update in the first half of 2027."

The introduction of these algorithms will build on Ceribell's continued expansion of its AI-powered EEG platform across the acute-care setting, including recent clearances for neonatal seizure detection² and delirium monitoring.³ Together, these updates reflect Ceribell's ongoing commitment to making comprehensive brain monitoring available to a wider variety of patients — regardless of age or care setting.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding the benefits of Ceribell's technology and the continued evolution of the Ceribell platform, are forward-looking statements. These statements are based on management's current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those described, including those related to regulatory approvals, clinical use and adoption, market acceptance, and competition, as described under the "Risk Factors" sections of the Company's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other reports filed with the U.S. Securities and Exchange Commission ("SEC"). These filings are available on the SEC's website and on Ceribell's investor relations website. Ceribell undertakes no obligation to update any forward-looking statements as a result of new information, future events, or otherwise, except as required by law.

About Ceribell, Inc.
Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. Ceribell has developed the Ceribell System, a novel, point-of-care electroencephalography ("EEG") platform specifically designed to address the unmet needs of patients in the acute-care setting. By combining proprietary, highly portable, and rapidly deployable hardware with sophisticated artificial intelligence ("AI")-powered algorithms, the Ceribell System enables rapid diagnosis and continuous monitoring of patients with neurological conditions. Ceribell is headquartered in Sunnyvale, California. For more information, please visit www.ceribell.com or follow the company on LinkedIn.

Investor Contact
Brian Johnston
Gilmartin Group
Investors@ceribell.com

Media Contact
Laura Hartlieb
Press@ceribell.com

¹ FDA 510(k) Clearance Letter K261712
² FDA 510(k) Clearance Letter K252070
³ FDA 510(k) Clearance Letter K251936

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What new Ceribell software did the FDA clear?

The FDA cleared software adding quantitative EEG trending and amplitude-integrated EEG analysis to the Ceribell System. The capabilities include Alpha-Delta Ratio and Relative Alpha trending, burst suppression monitoring, and amplitude-integrated EEG. The clearance carries no age restriction.

When will Ceribell integrate the newly cleared EEG features?

Ceribell expects to integrate the newly cleared features through an automatic software update in the first half of 2027.