Ceribell Receives FedRAMP® High Authorization, Expanding Approval for Its AI-Powered Point-of-Care EEG Across Federal Healthcare Systems

Ceribell is one of only 51 companies in the U.S. to achieve FedRAMP High authorization Ceribell's breakthrough technology can now be deployed in federal healthcare facilities, including U.S. Department of Veterans Affairs hospitals, helping clinicians deliver faster diagnosis and treatment for patients at risk of non-convulsive seizures SUNNYVALE, Calif., April 30, 2025 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell”), a medical technology company transforming the diagnosis and management of patients with serious neurological conditions, announced today that its point-of-care electroencephalogram (EEG) system has received full FedRAMP® (Federal Risk and Authorization Management Program) High authorization from the U.S. government. This elite cybersecurity authorization is awarded to organizations that meet the government’s highest security requirements. Ceribell’s secure, cloud-based solution can now be adopted across federal healthcare systems, expanding access to rapid diagnosis of non-convulsive seizures for U.S. veterans and other high-risk patients. As of April 28, 2025, only 51 companies in the U.S. have achieved High authorization, and there are no other medical device companies on that list. Designed for rapid setup and continuous brain monitoring, the Ceribell system is already in use at hospitals within the Department of Veterans Affairs (VA) after receiving Authority to Operate (ATO) in 2024. Now, FedRAMP High authorization paves the way for broader implementation throughout federal healthcare agencies, including the entire VA system, enabling more efficient deployment and secure data sharing between facilities. Achievement of this designation further establishes Ceribell as a trusted partner to health systems and validates its commitment to securing patient data while enhancing patient care. With FedRAMP® High authorization, Ceribell’s secure, cloud-based solution can be adopted across federal healthcare systems, expanding access to rapid diagnosis of non-convulsive seizures for U.S. veterans and other high-risk patients. "The FedRAMP High authorization underscores Ceribell’s leadership in both medical innovation and information security," said Jane Chao, Ph.D., co-founder and CEO of Ceribell. "It places us in the company of leading cloud and technology organizations that have met the most stringent federal cybersecurity standards. More importantly, this designation enables broader deployment of our rapid EEG system, to equip clinicians throughout federal healthcare networks with the tools they need to deliver faster diagnoses and more informed treatment decisions." FedRAMP is the federal government’s standardized approach to assessing the security of cloud-based systems. The FedRAMP High authorization status represents the highest level of security within this framework, with rigorous requirements for protecting sensitive data, including patient health information. As of April 2025, fewer than 15% of FedRAMP Authorized systems meet the High security standard. "Securing FedRAMP High authorization was the result of a focused and highly collaborative effort,” said Therese Charles, CISA, CDPSE, Executive Director of Information Security and IT at Ceribell. “Every layer of our cloud environment was thoroughly evaluated, from encryption and access controls to monitoring and incident response. This milestone reflects Ceribell's dedication to meeting the government’s most exacting cybersecurity standards and confirms the Ceribell EEG Portal is ready to support secure, scalable deployments in mission-critical federal healthcare environments." To view Ceribell’s listing on the FedRAMP Marketplace, visit: https://marketplace.fedramp.gov/products/FR2317262742 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 (Nasdaq: CBLL) 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 ContactBrian Johnston or Laine MorganGilmartin GroupInvestors@ceribell.com Media ContactCorrie RosePress@ceribell.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9cb8fdc3-2084-4bdc-bc7b-82205d35dcac

Ceribell Receives FedRAMP® High Authorization, Expanding Approval for Its AI-Powered Point-of-Care EEG Across Federal Healthcare Systems

FAQ

Why Bullish?

How important is it?

Why Long Term?

Related Companies

Related News