CeriBell Receives FDA 510(k) Clearance for Delirium Monitoring Solution
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 09 2025
0mins
Should l Buy CBLL?
CeriBell announced that the U.S. Food and Drug Administration, FDA, has granted 510(k) clearance for its proprietary delirium monitoring solution,1 the first and only FDA cleared delirium screening and monitoring device. This clearance further establishes the Ceribell System as an AI-powered brain monitoring platform technology, extending the benefits to a larger population of critically ill patients and providing additional information to assist in diagnosing patients at risk for both seizures and delirium.
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Analyst Views on CBLL
Wall Street analysts forecast CBLL stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for CBLL is 25.17 USD with a low forecast of 17.00 USD and a high forecast of 30.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
7 Analyst Rating
7 Buy
0 Hold
0 Sell
Strong Buy
Current: 20.480
Low
17.00
Averages
25.17
High
30.00
Current: 20.480
Low
17.00
Averages
25.17
High
30.00
About CBLL
CeriBell, Inc. is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Company has developed the Ceribell System, a point-of-care electroencephalography (EEG) platform specifically designed to address the unmet needs of patients in the acute care setting. By combining highly portable and rapidly deployable hardware with artificial intelligence-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 utilized in intensive care units and emergency rooms across the United States. Clarity, its machine learning algorithm, continuously interprets a patient’s EEG waveforms and displays actionable insights regarding seizure activity on the recorder. Its EEG portal is a cloud-based portal that enables real-time remote access to a patient’s EEG data.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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CeriBell's Stock Performance: CeriBell, Inc. (CBLL) shares increased by 5.39%, rising $1.09 to $21.31 following the FDA's 510(k) clearance for its EEG-based diagnostic tool for delirium.
Regulatory Milestone: The FDA clearance marks a significant regulatory achievement, paving the way for the commercialization of CeriBell's device in hospitals and acute-care settings.
Impact on Patient Care: The new diagnostic tool aims to enhance early detection of delirium, potentially improving patient outcomes and reducing healthcare costs.
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See More
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- Market Growth Potential: The AI medical imaging market is projected to grow at an annual rate of 25.8% through 2034, driving a shift in healthcare from traditional hardware to agile, software-defined intelligence, creating significant opportunities for companies like VentriPoint.
- Successful Funding: VentriPoint doubled its private placement from $500,000 to $1 million, with proceeds earmarked for critical commercialization activities and manufacturing scale-up, ensuring the company maintains a competitive edge in the rapidly evolving market.
- Strategic Partnership: VentriPoint is collaborating with Summit Sciences to develop advanced ROI models aimed at demonstrating the economic value of its technology to healthcare providers, thereby enhancing market competitiveness and driving customer adoption.
- Executive Appointment: VentriPoint appointed David Swetlow as CFO, bringing over 15 years of management experience in the medical technology sector, which is viewed as a key step in executing strategies to drive market adoption and revenue growth.
See More
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- Breakthrough Device Certification: CeriBell's stroke monitoring device has received FDA Breakthrough Device Designation, utilizing existing EEG technology and an AI-driven algorithm to significantly enhance the detection speed of Large Vessel Occlusion strokes in hospitals, which is expected to improve patient outcomes.
- Technological Innovation: This device is the first of its kind to combine EEG technology with an AI-driven algorithm, enabling rapid stroke identification that helps hospitals reduce diagnostic time, thereby increasing patient survival rates and recovery quality.
- Market Prospects: CeriBell has also recently received FDA approvals for its technologies aimed at detecting seizures and monitoring delirium, indicating the company's ongoing innovation capabilities in the neuro-monitoring field, which may lay the groundwork for future market expansion.
- Stock Price Reaction: CBLL shares rose 3.12% to $21.97 in Nasdaq trading, reflecting positive market sentiment towards this breakthrough technology, which could enhance investor confidence and drive future company growth.
See More
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- Conference Announcement: CeriBell CEO and Co-founder Dr. Jane Chao will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on January 12, 2026, showcasing the company's innovations in the diagnosis and management of neurological diseases.
- Technology Highlight: The Ceribell System, developed by CeriBell, is a novel point-of-care EEG platform that combines portable hardware with AI algorithms to address unmet needs of patients in acute care settings, enhancing diagnostic efficiency.
- Market Positioning: The Ceribell System is FDA-cleared for rapid detection of seizures and delirium in intensive care units and emergency rooms across the U.S., marking the strategic significance of the company in the medical technology sector.
- Investor Relations: The conference will feature live and archived webcasts, further enhancing investor understanding of CeriBell's innovative capabilities and market potential, fostering interaction between the company and its investors.
See More
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- Innovative Collaboration: Ventripoint's partnership with Nisg̱a'a Valley Health Authority establishes a model that transforms standard 2D ultrasound images into MRI-level 3D models using the VMS+ system, significantly enhancing cardiac assessment capabilities in remote and Indigenous communities while reducing costs and eliminating the need for MRI scans.
- Technology Accessibility Plan: The collaboration employs a hub-and-spoke model where a central hub provides advanced cardiac capabilities to support remote healthcare, ensuring high-quality cardiac diagnostics are accessible even in isolated areas, thereby improving healthcare service availability.
- Future Expansion Vision: Ventripoint plans to extend this model to other First Nations communities across Canada and remote regions globally, including areas in the Amazon, Africa, and India, aiming to eliminate geographical barriers and ensure everyone has access to advanced diagnostic services.
- Management Change: Ventripoint appointed David Swetlow as CFO in October, bringing over 15 years of management experience from medical technology firms, which is expected to drive market adoption and revenue growth across international markets.
See More
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- Innovative Collaboration: Ventripoint's partnership with Nisg̱a'a Valley Health Authority establishes a model for advanced cardiac imaging using the VMS+ system, transforming standard 2D ultrasound into MRI-level 3D models, significantly enhancing cardiac assessment capabilities in remote communities while reducing costs and eliminating delays associated with MRI scans.
- Strategic Technology Deployment: The collaboration employs a hub-and-spoke model where a central hub supports healthcare providers in remote areas, enabling local providers to quickly transmit ultrasound scans for rapid interpretation, which enhances diagnostic speed and treatment decisions, ultimately improving patient care quality.
- Market Expansion Potential: Future phases aim to extend this model to additional First Nations communities across Canada and globally to remote areas, including the Amazon, Africa, and India, addressing the need for advanced cardiac imaging services where MRI access is limited, thereby meeting the global demand for high-quality healthcare.
- Management Change: Ventripoint appointed David Swetlow as CFO in October, bringing over 15 years of experience in high-growth medical technology firms, which is expected to drive market adoption and revenue growth across international markets, thereby strengthening the execution of the company's commercial strategy.
See More
CeriBell Stock Jumps 5.4% Following FDA Approval of Innovative Delirium EEG Device
CeriBell's Stock Performance: CeriBell, Inc. (CBLL) shares increased by 5.39%, rising $1.09 to $21.31 following the FDA's 510(k) clearance for its EEG-based diagnostic tool for delirium.
Regulatory Milestone: The FDA clearance marks a significant regulatory achievement, paving the way for the commercialization of CeriBell's device in hospitals and acute-care settings.
Impact on Patient Care: The new diagnostic tool aims to enhance early detection of delirium, potentially improving patient outcomes and reducing healthcare costs.
Investor Reaction: The announcement led to above-average trading volume for CBLL, reflecting heightened investor interest, with the stock's 52-week range noted between $12.40 and $24.80.
See More
