Ceribell Receives Authority to Operate from the U.S. Department of Veterans Affairs
Ceribell (NASDAQ: CBLL) has received Authority to Operate (ATO) from the Department of Veterans Affairs, enabling full deployment of its point-of-care EEG technology across VA hospitals. This authorization allows Ceribell to leverage VA Wi-Fi networks for remote access to EEG reports and data sharing between locations. The system, which has been used in certain VA facilities since 2018, aims to reduce costly ICU admissions and intra-facility patient transfers while supporting timely interventions for veterans, who face elevated risks of seizure disorders. The Ceribell System combines portable hardware with AI-powered algorithms for rapid diagnosis and continuous monitoring, and has been adopted by over 500 hospitals, serving more than 100,000 patients.
Ceribell (NASDAQ: CBLL) ha ricevuto l'Autorizzazione all'Operatività (ATO) dal Dipartimento dei Veterani, consentendo il pieno dispiegamento della sua tecnologia EEG point-of-care negli ospedali VA. Questa autorizzazione permette a Ceribell di utilizzare le reti Wi-Fi degli ospedali VA per l'accesso remoto ai report EEG e la condivisione dei dati tra le varie sedi. Il sistema, utilizzato in alcune strutture VA dal 2018, punta a ridurre le costose ammissioni in terapia intensiva e i trasferimenti di pazienti all'interno delle strutture, supportando interventi tempestivi per i veterani che affrontano un rischio elevato di disturbi convulsivi. Il Sistema Ceribell combina hardware portatile con algoritmi basati su intelligenza artificiale per diagnosi rapida e monitoraggio continuo, ed è stato adottato da oltre 500 ospedali, servendo più di 100.000 pazienti.
Ceribell (NASDAQ: CBLL) ha recibido la Autorización para Operar (ATO) del Departamento de Asuntos de Veteranos, lo que permite el despliegue completo de su tecnología EEG point-of-care en los hospitales VA. Esta autorización permite a Ceribell aprovechar las redes Wi-Fi de los hospitales VA para acceder de forma remota a los informes EEG y compartir datos entre ubicaciones. El sistema, que se ha utilizado en ciertas instalaciones VA desde 2018, tiene como objetivo reducir las costosas admisiones en UCI y las transferencias de pacientes entre instalaciones, al tiempo que apoya intervenciones rápidas para los veteranos, que enfrentan un mayor riesgo de trastornos convulsivos. El Sistema Ceribell combina hardware portátil con algoritmos impulsados por inteligencia artificial para un diagnóstico rápido y monitoreo continuo, y ha sido adoptado por más de 500 hospitales, atendiendo a más de 100,000 pacientes.
세리벨(Ceribell) (NASDAQ: CBLL)은 재향 군인부(Department of Veterans Affairs)로부터 운영 승인(ATO)을 받아 VA 병원 전역에서 포인트 오브 케어(점검 포인트) EEG 기술을 완전히 배포할 수 있게 되었습니다. 이 승인으로 세리벨은 VA의 Wi-Fi 네트워크를 활용하여 EEG 보고서에 원격으로 접근하고 여러 장소 간 데이터 공유를 할 수 있게 되었습니다. 2018년부터 일부 VA 시설에서 사용된 이 시스템은 비용이 많이 드는 중환자실(ICU) 입원 및 시설 내 환자 전환을 줄이고, 발작 장애의 높은 위험에 직면하는 재향 군인을 위해 신속한 개입을 지원하는 것을 목표로 하고 있습니다. 세리벨 시스템은 휴대용 하드웨어와 AI 기반 알고리즘을 결합하여 신속한 진단 및 지속적인 모니터링을 수행하며, 500개 이상의 병원에서 채택되어 100,000명 이상의 환자를 치료하고 있습니다.
Ceribell (NASDAQ: CBLL) a reçu l'Autorisation d'Exploitation (ATO) du Département des Anciens Combattants, permettant le déploiement complet de sa technologie EEG point-of-care dans les hôpitaux VA. Cette autorisation permet à Ceribell de tirer parti des réseaux Wi-Fi des hôpitaux VA pour un accès à distance aux rapports EEG et le partage de données entre les différents sites. Le système, qui est utilisé dans certaines installations VA depuis 2018, vise à réduire les admissions coûteuses en soins intensifs et les transferts de patients entre les établissements, tout en soutenant les interventions rapides pour les vétérans, qui sont confrontés à des risques accrus de troubles convulsifs. Le système Ceribell combine du matériel portable avec des algorithmes alimentés par l'IA pour un diagnostic rapide et un suivi continu, et a été adopté par plus de 500 hôpitaux, desservant plus de 100 000 patients.
Ceribell (NASDAQ: CBLL) hat die Genehmigung zur Betriebsaufnahme (ATO) vom US-Verteidigungsministerium erhalten, die den vollständigen Einsatz seiner Point-of-Care-EEG-Technologie in VA-Krankenhäusern ermöglicht. Diese Genehmigung erlaubt es Ceribell, die Wi-Fi-Netzwerke der VA zu nutzen, um remote auf EEG-Berichte zuzugreifen und Daten zwischen verschiedenen Standorten auszutauschen. Das System, das seit 2018 in bestimmten VA-Einrichtungen verwendet wird, zielt darauf ab, kostspielige ICU-Aufnahmen und die Überweisung von Patienten innerhalb der Einrichtungen zu reduzieren und dabei zeitnahe Interventionen für Veteranen zu unterstützen, die einem erhöhten Risiko für Anfallsstörungen ausgesetzt sind. Das Ceribell-System kombiniert tragbare Hardware mit KI-gestützten Algorithmen für eine schnelle Diagnose und kontinuierliche Überwachung und wurde von über 500 Krankenhäusern übernommen, die mehr als 100.000 Patienten bedienen.
- Received Authority to Operate (ATO) from VA, expanding market access
- System deployed in over 500 hospitals, serving 100,000+ patients
- Holds FDA 510(k) clearance and two FDA Breakthrough Device Designations
- Received New Technology Add-on Payment (NTAP) from CMS
- First device to receive 510(k) clearance for diagnosing electrographic status epilepticus
- None.
Insights
The VA's Authority to Operate (ATO) approval represents a significant commercial milestone for Ceribell, opening access to one of America's largest healthcare networks. With over
The technology addresses a critical need in the VA system, where veterans have higher rates of seizure disorders. The Ceribell System's rapid deployment capability and AI-powered algorithms provide immediate clinical value by reducing costly ICU admissions and inter-facility transfers. The recent CMS New Technology Add-on Payment (NTAP) designation further strengthens the reimbursement pathway.
With an existing footprint in over 500 hospitals and 100,000 patient uses, the VA authorization could drive significant growth in both system deployments and recurring revenue from disposable EEG headbands.
The ATO certification validates Ceribell's cybersecurity and interoperability capabilities, which are important for enterprise-wide healthcare deployments. This approval removes a major barrier to widespread VA adoption and creates a compelling reference case for other large healthcare networks.
The VA implementation will be streamlined through the National Tele-EEG program, enabling rapid scaling across facilities. The system's proven ability to reduce ICU stays and patient transfers aligns perfectly with healthcare cost containment initiatives. Early detection and management of non-convulsive seizures represent substantial cost savings opportunities for the VA system.
The combination of FDA Breakthrough Device designations, unique 510(k) clearance for status epilepticus diagnosis and now VA authorization positions Ceribell as the clear leader in rapid EEG technology.
—Ceribell System stands to reduce costly ICU admissions and intra-facility patient transfers—
—Military veterans face elevated risks of developing seizure disorders—
SUNNYVALE, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions (“Ceribell”), today announced the receipt of an Authority to Operate (ATO) from the Department of Veterans Affairs (VA). The ATO is a significant milestone in achieving authorization within the framework of federal government cloud computing security requirements and it allows Veterans Administration (VA) hospitals to fully deploy Ceribell’s point-of-care EEG technology.
While Ceribell has been used in certain VA facilities since 2018, this ATO allows Ceribell to leverage VA Wi-Fi networks, enabling remote access to EEG reports and sharing of EEG data between VA locations. Broader use of Ceribell’s features will enable VA hospitals to more efficiently manage neurological emergencies by supporting timely interventions and improved patient outcomes.1-3 The Ceribell System has the potential to provide continuity of care and reduce costs by helping to avoid the transfer of patients to other facilities.4
Veterans are at elevated risk of being diagnosed with a seizure disorder, due to conditions such as traumatic brain injury and post-traumatic stress disorder.5,6 Ceribell equips frontline healthcare providers with a rapid EEG tool and continuous brain monitoring for critically-ill patients. The Ceribell solution enables VA hospitals to quickly identify and manage non-convulsive seizures, which are difficult to detect and can only be diagnosed with an EEG.
The VA’s National Tele-EEG program played a pivotal role in helping Ceribell achieve its ATO. The Tele-EEG program, which works to expand neurological care for veterans across the U.S., will manage the implementation of Ceribell across VA hospitals.
"As a veteran, it’s incredibly rewarding to see Ceribell's rapid EEG technology bringing timely insights to VA medical centers across the country,” said Matthew Osucha, FACHE, federal sales leader for Ceribell and a U.S. Army veteran. “This technology empowers clinicians to make faster, potentially life-saving decisions for those who have served our country."
“Our veterans deserve access to the best care and the most cutting-edge technology possible," said Jane Chao, Ph.D., co-founder and chief executive officer of Ceribell. "In addition to bringing Ceribell’s game-changing rapid detection and continuous monitoring capabilities to one of the largest healthcare systems in the U.S., this Authority to Operate can help VA clinicians improve care by optimizing when anti-seizure medication is used and by reducing costly ICU stays and intra-facility patient transfers."
For more information about Ceribell AI-powered point-of-care EEG, visit https://ceribell.com/product/point-of-care-eeg/.
About the Ceribell System
The Ceribell system is a novel, point-of-care EEG platform designed to address the unmet needs of patients in the acute care setting. By combining proprietary, highly portable, and rapidly deployable hardware with a sophisticated AI-powered algorithm, the Ceribell system enables rapid diagnosis and continuous monitoring of patients with neurological conditions. The Ceribell system is FDA 510(k) cleared for indicating suspected seizure activity and currently utilized in intensive care units and emergency rooms across the U.S. The Ceribell system received two FDA Breakthrough Device Designations in 2022, and in 2023, the latest generation of Ceribell’s AI algorithm (Clarity™) made it the first and only device to receive 510(k) clearance for diagnosing electrographic status epilepticus. Subsequently, the Clarity algorithm received a New Technology Add-on Payment (NTAP) from the Centers for Medicare and Medicaid Services (CMS). The Ceribell System has been adopted by more than 500 hospitals and has been used to diagnose and monitor over 100,000 patients.
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 510(k) cleared 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.
MEDIA CONTACT
Corrie Rose
press@ceribell.com
INVESTOR CONTACTS
Brian Johnston
Laine Morgan
investors@ceribell.com
References
- Hobbs, K., et al. (2018) Neurocrit Care. 29(2):302-312
- Yazbeck, M., et al. (2019) J Neurosci Nurs. 51(6):308-312
- Desai, M., et al. (2024). Neurocrit Care
- Ward, J., et al. (2023) Front. Digit. Health. 5(1)
- Rehman, R., et al. (2015) J Rehabil Res Dev. 52(7):751-762
- (2014) Office of Research & Development. research.va.gov/currents/winter2013-14/winter2013-14-19.cfm
FAQ
What is the significance of Ceribell's (CBLL) VA Authority to Operate approval in 2024?
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