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

Rhea-AI Summary

Ceribell has achieved FedRAMP High authorization for its AI-powered point-of-care EEG system, becoming one of only 51 companies in the U.S. to receive this elite cybersecurity designation. The company (Nasdaq: CBLL) can now expand its presence across federal healthcare facilities, including VA hospitals.

The authorization enables broader implementation of Ceribell's secure, cloud-based solution throughout federal healthcare agencies, facilitating faster diagnosis of non-convulsive seizures in veterans and high-risk patients. As of April 2025, fewer than 15% of FedRAMP Authorized systems meet the High security standard, and Ceribell is currently the only medical device company on the list.

The system, which received Authority to Operate (ATO) in 2024, is already in use at VA hospitals. This new authorization validates Ceribell's commitment to data security while enhancing patient care, positioning it among leading cloud and technology organizations meeting stringent federal cybersecurity standards.

Positive

• Achieved FedRAMP High authorization - highest federal security clearance, joining only 51 companies in US
• First medical device company to receive this elite cybersecurity authorization
• Enables broader implementation across VA system and federal healthcare agencies
• Already operational in VA hospitals after receiving ATO in 2024
• Positions company for expanded market access in federal healthcare sector

Negative

• Limited operating history and history of net losses mentioned in risk factors
• Heavy manufacturing dependence on China for components
• Reliance on limited number of suppliers
• Product defects and liability risks highlighted in forward-looking statements
• Reimbursement level uncertainties for products

Insights

Healthcare Technology Analyst

Ceribell's FedRAMP High authorization creates significant competitive advantage for federal healthcare market access, particularly with VA hospitals serving millions of veterans.

Ceribell's achievement of FedRAMP High authorization represents a substantial market expansion opportunity in the federal healthcare sector. As one of only 51 companies nationwide to obtain this elite cybersecurity certification—and reportedly the only medical device company on this list—Ceribell has established a formidable competitive moat for government contracts.

The authorization builds upon Ceribell's existing foothold in VA hospitals (established via ATO in 2024) and now enables broader deployment throughout the entire federal healthcare ecosystem. This removes a significant barrier to adoption across the VA system, which serves millions of veterans across numerous medical facilities.

What makes this particularly valuable is the high barrier to entry FedRAMP High authorization represents—fewer than 15% of FedRAMP Authorized systems meet this stringent security standard. For a medical technology company handling sensitive patient data, this designation validates Ceribell's robust information security infrastructure.

The company's AI-powered point-of-care EEG system addresses a critical clinical need for rapid diagnosis of non-convulsive seizures, a condition requiring prompt treatment. By enabling faster diagnosis in federal healthcare settings, Ceribell positions itself as both a technology innovator and a trusted security partner—a rare combination in healthcare technology.

While the immediate revenue impact isn't quantified, the expanded market access represents significant long-term potential as federal procurement processes advance. This authorization effectively creates a competitive advantage in the federal healthcare market that competitors cannot easily replicate.

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 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/9cb8fdc3-2084-4bdc-bc7b-82205d35dcac

FAQ

What is the significance of Ceribell (CBLL) receiving FedRAMP High authorization in 2025?

Ceribell's FedRAMP High authorization makes it one of only 51 companies in the U.S. to achieve this elite cybersecurity status, allowing its AI-powered EEG system to be deployed across federal healthcare facilities, including VA hospitals. This enables secure, broader implementation and data sharing between facilities.

How will FedRAMP High status impact Ceribell's (CBLL) market reach in federal healthcare?

The FedRAMP High authorization enables Ceribell to expand its EEG system deployment across the entire VA system and federal healthcare agencies, increasing access to rapid seizure diagnosis for veterans and high-risk patients while ensuring the highest level of data security.

What percentage of companies have achieved FedRAMP High authorization like Ceribell (CBLL)?

As of April 2025, fewer than 15% of FedRAMP Authorized systems meet the High security standard, and Ceribell is the only medical device company among the 51 U.S. companies that have achieved this highest level of authorization.

What medical capabilities does Ceribell's (CBLL) FedRAMP-authorized EEG system offer?

Ceribell's point-of-care EEG system provides rapid setup and continuous brain monitoring, enabling faster diagnosis and treatment for patients at risk of non-convulsive seizures, with secure cloud-based data sharing between facilities.

When did Ceribell (CBLL) first receive VA Authority to Operate (ATO)?

Ceribell received Authority to Operate (ATO) from the Department of Veterans Affairs in 2024, before achieving the full FedRAMP High authorization in April 2025.