FDA Clears Ceribell’s Clarity™ Algorithm for Pediatric Patients, Making Ceribell the First and Only FDA-Cleared AI Technology for Detection of Electrographic Seizures in Patients Ages 1 Year and Older
Ceribell (Nasdaq: CBLL) has received FDA 510(k) clearance for its Clarity™ algorithm, becoming the first and only AI-powered point-of-care EEG system cleared to detect electrographic seizures in patients aged 1 year and older. The clearance was supported by EEG data from over 1,700 patients, marking the largest validation dataset ever used for FDA clearance of a seizure detection system.
The Clarity algorithm works with Ceribell's existing EEG headbands and enables rapid, bedside detection, diagnosis, and treatment of non-convulsive seizures in children experiencing neurological emergencies. Clinical guidelines recommend initiating EEG within 15-60 minutes of suspected continuous non-convulsive seizures, but children often face hours or days of waiting for assessment. This technology aims to address this critical gap by providing immediate bedside neurological assessment.
Ceribell (Nasdaq: CBLL) ha ottenuto l'autorizzazione FDA 510(k) per il suo algoritmo Clarity™, diventando il primo e unico sistema EEG point-of-care alimentato da intelligenza artificiale approvato per rilevare crisi epilettiche elettroencefalografiche in pazienti di età pari o superiore a 1 anno. L'autorizzazione è stata supportata da dati EEG provenienti da oltre 1.700 pazienti, rappresentando il più ampio dataset di validazione mai utilizzato per l'approvazione FDA di un sistema di rilevamento delle crisi.
L'algoritmo Clarity funziona con le fasce EEG già esistenti di Ceribell e consente una rapida rilevazione, diagnosi e trattamento a letto del paziente delle crisi non convulsive nei bambini con emergenze neurologiche. Le linee guida cliniche raccomandano di iniziare l'EEG entro 15-60 minuti dal sospetto di crisi non convulsive continue, ma i bambini spesso devono aspettare ore o giorni per la valutazione. Questa tecnologia mira a colmare questa importante lacuna offrendo una valutazione neurologica immediata a letto del paziente.
Ceribell (Nasdaq: CBLL) ha recibido la aprobación FDA 510(k) para su algoritmo Clarity™, convirtiéndose en el primer y único sistema EEG de punto de atención impulsado por IA aprobado para detectar convulsiones electrográficas en pacientes de 1 año en adelante. La aprobación se basó en datos EEG de más de 1,700 pacientes, marcando el conjunto de datos de validación más grande utilizado para la aprobación FDA de un sistema de detección de convulsiones.
El algoritmo Clarity funciona con las bandas EEG existentes de Ceribell y permite la detección rápida, el diagnóstico y el tratamiento junto a la cama de convulsiones no convulsivas en niños que enfrentan emergencias neurológicas. Las guías clínicas recomiendan iniciar el EEG dentro de los 15-60 minutos posteriores a la sospecha de convulsiones no convulsivas continuas, pero los niños a menudo enfrentan horas o días de espera para la evaluación. Esta tecnología busca cubrir esta brecha crítica proporcionando una evaluación neurológica inmediata junto a la cama.
Ceribell (나스닥: CBLL)은(는) Clarity™ 알고리즘에 대해 FDA 510(k) 승인을 받아 1세 이상 환자의 전기생리적 발작을 감지할 수 있는 최초이자 유일한 AI 기반 현장 EEG 시스템이 되었습니다. 이 승인은 1,700명 이상의 환자 EEG 데이터를 바탕으로 이루어졌으며, 발작 감지 시스템 FDA 승인에 사용된 최대 규모의 검증 데이터셋입니다.
Clarity 알고리즘은 Ceribell의 기존 EEG 헤드밴드와 함께 작동하며, 신경학적 응급 상황에 처한 어린이의 비경련성 발작을 신속하게 병상에서 감지, 진단 및 치료할 수 있게 합니다. 임상 지침은 의심되는 지속적인 비경련성 발작 발생 시 15-60분 이내에 EEG를 시작할 것을 권고하지만, 어린이들은 종종 평가를 위해 몇 시간 또는 며칠을 기다려야 합니다. 이 기술은 즉각적인 병상 신경 평가를 제공하여 이 중요한 공백을 해소하는 것을 목표로 합니다.
Ceribell (Nasdaq : CBLL) a obtenu l'autorisation FDA 510(k) pour son algorithme Clarity™, devenant ainsi le premier et unique système EEG point de soin alimenté par IA autorisé à détecter les crises électrographiques chez les patients âgés d'un an et plus. Cette autorisation a été soutenue par des données EEG provenant de plus de 1 700 patients, constituant le plus grand ensemble de données de validation jamais utilisé pour une autorisation FDA d'un système de détection des crises.
L'algorithme Clarity fonctionne avec les bandeaux EEG existants de Ceribell et permet une détection, un diagnostic et un traitement rapides au chevet des crises non convulsives chez les enfants en situation d'urgence neurologique. Les recommandations cliniques préconisent de débuter l'EEG dans les 15 à 60 minutes suivant la suspicion de crises non convulsives continues, mais les enfants doivent souvent attendre des heures voire des jours avant une évaluation. Cette technologie vise à combler cette lacune cruciale en offrant une évaluation neurologique immédiate au chevet.
Ceribell (Nasdaq: CBLL) hat die FDA 510(k)-Zulassung für seinen Clarity™-Algorithmus erhalten und ist damit das erste und einzige KI-gestützte Point-of-Care-EEG-System, das zur Erkennung elektrographischer Anfälle bei Patienten ab 1 Jahr zugelassen ist. Die Zulassung basierte auf EEG-Daten von über 1.700 Patienten und stellt den größten Validierungsdatensatz dar, der jemals für eine FDA-Zulassung eines Anfallserkennungssystems verwendet wurde.
Der Clarity-Algorithmus arbeitet mit den bestehenden EEG-Kopfbändern von Ceribell zusammen und ermöglicht eine schnelle, bettseitige Erkennung, Diagnose und Behandlung nicht-konvulsiver Anfälle bei Kindern mit neurologischen Notfällen. Klinische Leitlinien empfehlen, EEG innerhalb von 15-60 Minuten nach dem Verdacht auf anhaltende nicht-konvulsive Anfälle zu beginnen, doch Kinder müssen oft Stunden oder Tage auf eine Beurteilung warten. Diese Technologie soll diese kritische Lücke schließen, indem sie eine sofortige neurologische Beurteilung am Krankenbett ermöglicht.
- First-mover advantage in AI-powered pediatric seizure detection
- FDA clearance expands addressable market to include patients aged 1+
- Largest validation dataset (1,700+ patients) for FDA clearance in seizure detection
- Compatible with existing EEG headbands, no new hardware required
- operating history and history of net losses
- Heavy reliance on Chinese manufacturing for components
- Potential product liability risks from defects or complaints
- Dependent on number of suppliers
Insights
Ceribell's FDA 510(k) clearance for its Clarity™ algorithm represents a significant clinical and competitive advancement in pediatric neurology. As the first and only AI-powered point-of-care EEG system cleared for seizure detection in patients as young as 1 year old, Ceribell establishes a meaningful first-mover advantage in the pediatric neurological emergency market.
The clinical value proposition is compelling. Non-convulsive seizures require EEG detection and prompt treatment to prevent brain injury, yet children typically experience substantial delays in receiving EEG assessment—often waiting hours or days despite guidelines recommending EEG within 15-60 minutes. Ceribell's system directly addresses this critical care gap.
From a competitive standpoint, this clearance creates significant differentiation. The validation dataset of over 1,700 patients establishes a high barrier to entry for competitors seeking similar clearances. Additionally, Ceribell's platform now offers hospitals a unified solution across both pediatric and adult populations, creating operational efficiencies through standardization of equipment and training.
The company's strategy of leveraging their existing EEG headband hardware while expanding algorithmic capabilities demonstrates smart resource allocation. This approach allows Ceribell to expand their addressable market without significant additional manufacturing complexity or inventory diversification requirements.
For hospitals managing pediatric neurological emergencies, this technology potentially enables faster intervention in seizure cases, addressing a leading cause of neurology-related pediatric emergency department visits with a solution that can be implemented at the bedside.
This FDA clearance for Ceribell's Clarity™ algorithm substantially strengthens the company's market position by expanding its addressable audience to include pediatric patients ages 1 and older. The distinction of being first and only with this specific clearance creates a competitive moat that should translate to accelerated market penetration.
The clearance's strategic value stems from three key factors. First, it enables Ceribell to offer hospitals a complete solution across all age groups, potentially streamlining purchasing decisions and implementation. Second, the pediatric neurological emergency market represents an underserved segment with compelling clinical needs. Third, the validation using over 1,700 patients creates regulatory precedent that may delay competitive entries.
From an operational perspective, the ability to use existing EEG headband hardware with the new algorithm presents an efficient scaling opportunity. This approach maximizes return on existing manufacturing investments while opening new revenue channels. It also simplifies inventory management for both Ceribell and hospital customers.
The unmet clinical need this addresses is substantial. The detection of non-convulsive seizures—visible only through EEG—represents a critical diagnostic challenge where time directly impacts patient outcomes. By enabling point-of-care detection in pediatric populations, Ceribell addresses a genuine pain point in emergency and intensive care settings.
While the press release doesn't specify commercialization timeline beyond "soon" or discuss pricing strategy, this clearance positions Ceribell to potentially capture significant market share in pediatric neurodiagnostics ahead of competitors.
Powered by Clarity, the Ceribell System will enable rapid, bedside detection, diagnosis and treatment of non-convulsive seizures in children experiencing neurological emergencies
SUNNYVALE, Calif., April 15, 2025 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell”), 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 granted 510(k) clearance for its next generation Ceribell Clarity™ algorithm for the detection of electrographic seizures in patients ages 1 and older. This makes Ceribell the first and only AI-powered point-of-care EEG system cleared to detect electrographic seizures in children as young as 1 year old and to fully cover the age range from 1 year old to adult.1 Using Ceribell’s comprehensive solution, clinicians will be empowered to detect non-convulsive seizures in pediatric patients in real time, supporting rapid diagnosis and treatment to help prevent serious brain injury in one of the most common neurological emergencies that children face.2
Based on Ceribell’s assessment, its Clarity algorithm now provides coverage across the largest age range ever addressed by a seizure detection technology. This offers hospitals, particularly emergency departments and ICUs, a complete solution for detecting electrographic seizures in both pediatric and adult patients. The pediatric clearance was supported by electroencephalography (EEG) data collected from over 1,700 patients, which FDA data indicates is the largest validation dataset ever used for FDA clearance of a seizure detection system, reflecting the scale of Ceribell’s extensive EEG database and the rigor of its validation process and algorithm. The Clarity algorithm is designed to be used with the same Ceribell EEG headbands currently marketed for adults, which are cleared for use in patients of all ages.
FDA clearance of Ceribell’s Clarity™ algorithm will enable rapid, bedside detection, diagnosis, and treatment of non-convulsive seizures in children experiencing neurological emergencies.
"We believe this clearance will have a profound impact on the lives of critically ill children, who are particularly vulnerable to preventable brain injury," said Jane Chao, Ph.D., co-founder and CEO of Ceribell. "It is well understood that seizures can lead to poor clinical outcomes when not treated in a timely manner. Yet, until now, clinicians have never had access to point-of-care EEG with a seizure detection algorithm tailored specifically for pediatric patients as young as 1 year old. This breakthrough, which we expect to be commercially available soon, marks another important step toward our mission of making rapid EEG the standard of care for everyone."
Seizures are a leading cause of neurology-related pediatric emergency department visits.2 Non-convulsive seizure activity, which can only be detected with EEG, must be quickly identified and treated to prevent brain injury.3 Clinical guidelines recommend initiating EEG within 15–60 minutes of suspected continuous non-convulsive seizures in both children and adults.4 In practice, however, children often wait hours or even days for EEG assessment.5 Ceribell’s easy-to-use, AI-powered point-of-care EEG helps fill this critical gap by enabling prompt bedside neurological assessment and providing real-time insights into a patient’s condition.
References
- FDA 510k Clearance Letter K241589
- Pallin, D., et al (2008) Int J of Emer Med, 1(2), 97-105
- Payne, E.T., et al. (2014) Brain 137(5):1429-1438
- Brophy, G., et al. (2012) Neurocrit Care. 17(1):3-23
- Sánchez Fernández, I., et al. (2017) Epilepsia 58(3): 420–428
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our business plans, strategies, goals, prospects, assessments, beliefs and expectations for our products, and other statements that are not statements of historical fact. Given their forward-looking nature, these statements involve substantial risks, uncertainties, and potentially inaccurate assumptions, and we cannot ensure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope,” and other words and terms of similar meaning. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: risks related to the macroeconomic and geopolitical environment and the potential imposition of new or higher tariffs; risks related to our limited operating history and history of net losses; our ability to successfully achieve substantial market acceptance and adoption of our products; competitive pressures; our ability to adapt our manufacturing and production capacities to evolving patterns of demand, governmental actions and customer trends; the manufacturing of a substantial number of our product components and their assembly in China; product defects or complaints and related liability; the complexity, timing, expense, and outcomes of clinical studies; our ability to obtain and maintain adequate coverage and reimbursement levels for our products; our ability to comply with changing laws and regulatory requirements and resulting costs; our dependence on a limited number of suppliers; and other risks and uncertainties, including those described under the heading “Risk Factors” in our Annual Report on Form 10-K and other reports filed with the U.S. Securities and Exchange Commission (“SEC”). These filings, when made, are available on the Investor Relations section of our website at https://investors.ceribell.com and on the SEC’s website at https://sec.gov. We assume no obligation to update any forward-looking statements contained in this press release as a result of new information or future events or developments.
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. The Ceribell System is FDA-cleared (510(k)) for indicating suspected seizure activity and currently utilized in intensive care units and emergency rooms across the U.S. Ceribell is headquartered in Sunnyvale, California. For more information, please visit www.ceribell.com or follow the company on LinkedIn.
Investor Contact
Brian Johnston or Laine Morgan
Gilmartin Group
Investors@ceribell.com
Media Contact
Corrie Rose
Press@ceribell.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a5d2bbd3-b571-45d2-8d7f-7ed4a6e1c71e
FAQ
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