FDA Grants Ceribell has received 510(k) clearance from the U.S. Food and Drug Administration for its updated Clarity algorithm, which enables the detection of electrographic seizures in both preterm infants and adult patients.
According to the company, this authorization marks the first FDA-cleared artificial intelligence–supported electroencephalography system capable of identifying electrographic seizures across the entire age spectrum. The announcement was made in a press release dated Nov. 24.
The company previously secured clearance for a newborn-specific version of its head cap designed to support electroencephalography (EEG) monitoring in neonatal settings. The newly cleared algorithm represents an expansion of the system’s capabilities, addressing what the company describes as a significant clinical need in neonatal care.
Research cited by Ceribell indicates that approximately 9% of newborns in neonatal intensive care units (NICUs) may receive a seizure diagnosis, yet up to 90% of episodes may go unnoticed without EEG monitoring due to the lack of observable symptoms.
Jane Chao, Ph.D., co-founder and CEO of Ceribell, said, “Seizures are the most common neurological emergency in newborns, and protecting these fragile brains is essential to their long-term development and well-being.” She added that timely and accessible seizure detection is critical for this population.
While often associated with epilepsy, seizures may also arise from conditions such as traumatic brain injuries, stroke, tumors, cardiac arrest, sepsis, and postoperative recovery, sometimes without outward convulsions. Ceribell has stated that seizure activity may affect as many as one-third of patients in neurological critical care, potentially increasing the likelihood of persistent brain injury and long-term functional impairment.
Ceribell’s point-of-care EEG technology originally received FDA clearance in 2017 for identifying suspected seizure activity. The company noted that its most recent authorization makes the Ceribell System the only AI-enabled EEG platform cleared for seizure detection from preterm newborns through adults.
The decision was supported by EEG data from over 700 patients, which Ceribell described as the largest validation dataset used for a neonatal seizure detection system. The company also holds clearance for a headcap designed specifically for neonates, pairing hardware with the Clarity algorithm to support real-time detection of non-convulsive seizures.
The company reported that early seizure identification is a persistent gap in NICU care. Many facilities may lack the equipment or staff to provide continuous EEG monitoring, leading to treatment delays or transfers. Citing research, Ceribell stated that high-risk newborns experiencing more than 13 minutes of seizures per hour face increased chances of mortality or long-term disability. Recent guidelines from the American Clinical Neurophysiology Society recommend continuous EEG monitoring for newborns with conditions such as prematurity, congenital heart disease, or hypoxic-ischemic encephalopathy.
Commenting on the clinical challenges associated with neonatal seizure monitoring, Dr. Janene Fuerch of Stanford Children’s Hospital said that many NICUs do not have round-the-clock EEG access and that faster bedside tools may help address this gap.
FDA Grants Clearance for Ceribell’s Advanced Clarity Algorithm
The FDA Grants clearance for Ceribell’s upgraded Clarity algorithm, allowing it to detect electrographic seizures across all age groups, including infants, children, and adults. This clearance broadens clinical access to faster, AI-assisted neurological assessment.As the FDA Grants expanded clearance for broader use, the Clarity algorithm is expected to strengthen hospital workflows and improve patient outcomes for conditions that require immediate EEG assessment. The company emphasized that the technology’s accuracy and fast response time can be especially valuable where trained neurologists are not readily available.
The FDA Grants approval also reinforces the growing acceptance of AI-powered diagnostic support tools in modern healthcare. With Ceribell’s innovation now cleared for all ages, medical teams can rely on a more comprehensive solution that ensures continuous and reliable seizure monitoring.
Overall, the move underscores why the FDA Grants strategic clearances to technologies that elevate patient safety and streamline critical diagnostic processes.
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