• Ceribell Receives Authority to Operate from the U.S. Department of Veterans Affairs

    ソース: Nasdaq GlobeNewswire / 11 11 2024 08:00:00   America/New_York

    —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

    1. Hobbs, K., et al. (2018) Neurocrit Care. 29(2):302-312​
    2. Yazbeck, M., et al. (2019) J Neurosci Nurs. 51(6):308-312
    3. Desai, M., et al. (2024). Neurocrit Care
    4. Ward, J., et al. (2023) Front. Digit. Health. 5(1)
    5. Rehman, R., et al. (2015) J Rehabil Res Dev. 52(7):751-762
    6. (2014) Office of Research & Development. research.va.gov/currents/winter2013-14/winter2013-14-19.cfm

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