Ceribell's AI-Powered EEG Cleared to Guard Newborns' Brains

SUNNYVALE, CA – November 24, 2025 – In a landmark decision for neonatal care, the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Ceribell for its AI-driven ClarityⓇ algorithm, enabling the detection of seizures in the most fragile of patients: newborns. This regulatory milestone makes the Ceribell System the first and only point-of-care electroencephalography (EEG) technology powered by artificial intelligence to be cleared for all patient ages, from pre-term neonates through adults. The clearance marks a significant leap forward in the quest to protect a developing brain from the devastating, and often invisible, impact of seizure activity.

For medical professionals in neonatal intensive care units (NICUs), this approval addresses a long-standing and critical challenge. The technology promises to transform the standard of care by bringing rapid, accessible neurological monitoring directly to the bedside, potentially preventing irreversible brain damage in vulnerable infants.

The Silent Crisis in the NICU

Seizures are the most common neurological emergency in newborns, yet they are notoriously difficult to detect. Unlike the convulsive seizures often depicted in adults, neonatal seizures can be clinically subtle, manifesting as minor facial twitches, unusual eye movements, or even no outward signs at all. This silent nature means that without specialized monitoring, the vast majority of these neurological events go unnoticed.

Clinical research underscores the scale of the problem: while approximately 9% of NICU patients may experience seizures, studies suggest that up to 90% are subclinical, meaning they go completely undetected by bedside staff. The consequences of these missed diagnoses are severe. Data indicates that high-risk newborns who experience more than 13 minutes of seizure activity in an hour face an eight-fold increase in the risk of poor outcomes, including long-term disabilities like cerebral palsy, cognitive impairments, and even mortality.

The established gold standard for seizure detection is continuous EEG (cEEG), which records the brain's electrical activity. However, deploying cEEG in a busy NICU is a logistical and resource-intensive challenge. It requires specialized equipment that is often in short supply, a trained neurophysiologist to apply the electrodes and interpret the complex data, and significant time—a luxury that is often not available when a newborn's brain is at risk. This "EEG gap" means that many hospitals, particularly smaller or rural facilities, lack the capability for 24/7 monitoring, leading to diagnostic delays, risky patient transfers, and compromised care.

A New Technological Watchguard

Ceribell's system is designed to directly address these limitations. The platform combines a portable, easy-to-use headband EEG device with a cloud-based, AI-powered algorithm. The system can be set up by a nurse or physician in a matter of minutes, providing immediate, real-time analysis of a patient's brain activity. The ClarityⓇ algorithm continuously monitors the EEG data and provides an immediate alert for suspected seizure activity, transforming the EEG from a specialized, delayed procedure into an accessible, on-demand vital sign.

This latest FDA clearance was supported by a robust clinical validation dataset involving EEG data from over 700 patients—the largest such dataset ever used for a neonatal seizure detection system. In addition to the software algorithm, the company also secured clearance for a headcap specifically engineered and optimized for the unique anatomy of neonatal patients, ensuring a more reliable and comfortable fit.

"Seizures are the most common neurological emergency in newborns, and protecting these fragile brains is essential to their long-term development and well-being,” said Jane Chao, Ph.D., co-founder and CEO of Ceribell, in a statement. “This FDA clearance enables us to further expand availability of Ceribell’s rapid, AI-powered neurological monitoring technology and serve more patients in need. Every newborn deserves timely and accessible seizure detection, without the delays and transfers that too often put outcomes at risk.”

Redefining the Standard of Neurological Care

The introduction of an AI-powered, point-of-care EEG for all ages represents a paradigm shift in acute neurological assessment. It moves the field beyond simple product innovation and into a re-evaluation of clinical workflows and standards of care. Recent guidelines from the American Clinical Neurophysiology Society (ACNS) already recommend continuous EEG monitoring for neonates with a wide range of high-risk conditions, including hypoxic-ischemic encephalopathy (brain injury due to oxygen deprivation), congenital heart disease, and prematurity. Ceribell's technology provides a practical and scalable way for hospitals to meet these guidelines.

By empowering non-specialists to perform initial neurological assessments, the system can significantly reduce the time to diagnosis and intervention. This is particularly crucial in the "golden hours" following a neurological insult, where every minute counts.

Dr. Janene Fuerch, Medical Director of Neonatal ECMO at Stanford Children’s Hospital, highlighted the existing gap in care. “I have seen firsthand that many NICUs do not have 24/7 access to EEG," she stated. "There is a clear need for faster, more accessible tools to evaluate brain activity at the bedside – especially in those critical first hours of life.” Ceribell’s system directly answers this call, offering a solution that can be integrated into existing NICU protocols to provide a new layer of safety for high-risk infants.

Market Disruption and Future Growth

From a market perspective, this expanded clearance is a pivotal strategic move for Ceribell (Nasdaq: CBLL). The company has already demonstrated impressive growth, reporting a 38% year-over-year revenue increase to $21.2 million in the second quarter of 2025 and raising its full-year guidance. This new clearance unlocks the substantial neonatal intensive care market, a segment with a critical unmet need and a projected market value expected to grow significantly in the coming years.

Ceribell's competitive advantage lies not just in its technology but in its comprehensive, all-ages approach. While other companies like Natus Medical and Nihon Kohden offer sophisticated EEG systems, they often remain within the traditional paradigm requiring specialized personnel and longer setup times. Ceribell's "first and only" claim for an AI-powered, point-of-care system cleared for all demographics gives it a powerful market differentiator.

The company's business model, which includes both device sales and recurring subscription revenue for the ClarityⓇ algorithm, is well-positioned to benefit from this expansion. As more hospitals adopt the system for their NICUs, it will drive not only initial product sales but also a stable, growing stream of high-margin subscription income. This development solidifies Ceribell's mission to establish EEG as a new, universal vital sign, accessible in any acute care setting for any patient, at any time.