Ceribell Receives FDA Clearance for Advanced Epileptiform Abnormality Detection and Artifact Reduction for Its Cloud-Based Portal, Delivering Greater Precision for Critical-Care EEG Review
SUNNYVALE, Calif., Aug. 10, 2026 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell” or the “Company”), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for two new AI algorithm enhancements integrated directly into its existing cloud-based Neurology Portal: Epileptiform Abnormality Detection and Artifact Reduction.1 These new capabilities expand the clinical utility of the Ceribell Point-of-Care (POC) brain monitoring system, providing neurologists and bedside practitioners with an enhanced toolset for rapid, high-confidence electroencephalogram (EEG) assessment.
Ceribell’s new Neurology Portal enhancements introduce AI-driven algorithms designed to tackle two of the biggest hurdles in EEG evaluation: filtering complex background interference and streamlining the review of lengthy, ambiguous brain recordings.
Deploying EEGs in fast-paced, critical-care environments, such as emergency departments and intensive care units, is inherently difficult. Non-seizure signal disturbances, or artifacts, originating from nearby medical equipment, patient movement, and other physiological signals, are particularly common. Differentiating these sources of interference from the underlying brain signal can make EEG interpretation challenging and time-consuming, even for well-trained neurologists.
Ceribell’s new Artifact Reduction algorithm adds a layer of AI-driven sophistication to the existing approach. Beyond the simple filtering employed by most traditional technologies, the new algorithm recognizes and identifies various artifacts based on dedicated training on its own extensive real-world artifact dataset. This significantly simplifies EEG interpretation for neurologists and improves the point-of-care experience.
Another common challenge arises during the interpretation of lengthy brain recordings. Reviewing these continuous studies is an intensely time-consuming process because findings do not always fall into a binary “seizure” or “no seizure” distinction. Rather, many brain recordings in critical-care patients show abnormal epileptiform patterns that fall along the ictal-interictal continuum.
By analyzing a patient’s EEG recordings and flagging these specific epileptiform abnormalities, Ceribell’s new technology brings clear structure to this complex clinical gray zone, enabling more timely and precise patient care. Instead of wading through hours of raw data, the reviewing neurologist receives an organized, high-confidence starting point with potential pathology already prominently highlighted in the recording viewer, accelerating their read times and increasing efficiency.
“With these new Neurology Portal enhancements, Ceribell continues to push the boundaries of AI innovation in neuromonitoring,” said Jane Chao, Ph.D., co-founder and Chief Executive Officer of Ceribell. “This technology directly delivers on critical feedback from clinicians on the front lines. By automatically highlighting epileptiform patterns and isolating non-cerebral artifacts, we give valuable time back to neurologists. This empowers them to make fast, confident bedside decisions when every minute matters.”
Guided by real-world feedback from clinical users and backed by an expansive database of more than one million hours of EEG data, Ceribell continues to evolve its platform to maximize diagnostic confidence and ease hospital operational burdens. This portal update builds upon the Company’s industry-leading POC system, which reduces the time to initiate bedside monitoring from hours to as few as five minutes.2 The latest enhancements are engineered to seamlessly fit into existing clinical workflows with no software downtime or installation required.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding Ceribell’s industry leadership position, the benefits of Ceribell’s technology, and continued evolution of the Ceribell platform, are forward-looking statements. Forward-looking statements can be identified by the use of 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 of similar meaning. These statements are based on management’s current expectations and assumptions as of the date of this press release and involve risks and uncertainties that could cause actual results to differ materially from those described. Such risks and uncertainties, including but not limited to those related to regulatory approvals, clinical use and adoption, clinical outcomes, market acceptance, competition, and other factors, are described under the “Risk Factors” sections of the Company’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other reports filed with the U.S. Securities and Exchange Commission (“SEC”). These filings are available on the SEC’s website at https://www.sec.gov and on Ceribell’s website at https://investors.ceribell.com. Ceribell undertakes no obligation to update any forward-looking statements as a result of new information, future events, or otherwise, except as required by applicable law.
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 for use in detecting seizure and delirium in intensive care units and emergency rooms across the U.S. Ceribell is headquartered in Sunnyvale, California. For more information, please visit https://www.ceribell.com or follow the company on LinkedIn.
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1 FDA 510(k) Clearance Letter K260998
2 Vespa, P., et al. (2020) Crit Care Med. 48(9):1249-1257
