Novel technology paves the way for use of the company's industry-leading point-of-care electroencephalography (EEG) system to address long unmet need in delirium monitoringSUNNYVALE, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell”), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its proprieta ...

Core Insights - Ceribell, Inc. has received FDA 510(k) clearance for its Clarity algorithm, making it the first and only AI-powered EEG technology for detecting electrographic seizures in patients from pre-term neonates to adults [1][3] Group 1: Product and Technology - The Ceribell System combines proprietary algorithms with specialized hardware to enable real-time detection of non-convulsive seizures in neonatal patients, facilitating rapid diagnosis and treatment [3] - The FDA clearance was supported by EEG data from over 700 patients, representing the largest validation dataset for a neonatal seizure detection system [3] Group 2: Market Need and Impact - Early detection of seizures is critical in neonatal care, with approximately 9% of NICU patients diagnosed with seizures, while up to 90% may go undetected without EEG monitoring [2] - High-risk newborns who experience prolonged seizures have an 8-fold increased risk of poor outcomes, including mortality and long-term disability [2] - Recent guidelines recommend continuous EEG monitoring for neonates at high risk for seizures, highlighting the need for timely intervention [2] Group 3: Company Vision and Leadership - The CEO of Ceribell emphasized the importance of timely and accessible seizure detection for newborns, aiming to reduce delays and improve outcomes [4] - The Medical Director of Neonatal ECMO at Stanford Children's Hospital noted the lack of 24/7 EEG access in many NICUs, underscoring the need for faster, more accessible tools for evaluating brain activity [4] Group 4: Company Overview - Ceribell is focused on transforming the diagnosis and management of serious neurological conditions, with its system currently utilized in intensive care units and emergency rooms across the U.S. [7] - The company is headquartered in Sunnyvale, California, and aims to address unmet needs in acute care settings through its innovative EEG platform [7]

Core Insights - CeriBell, Inc. is focused on transforming the diagnosis and management of serious neurological conditions [3] - The company will present at the Piper Sandler 37 Annual Healthcare Conference on December 3, 2025 [2] Company Overview - CeriBell has developed the Ceribell System, a point-of-care electroencephalography (EEG) platform designed for acute care settings [3] - The Ceribell System combines portable hardware with AI-powered algorithms for rapid diagnosis and continuous monitoring of neurological conditions [3] - The system is FDA-cleared for detecting suspected seizure activity and is currently used in intensive care units and emergency rooms across the U.S. [3] - CeriBell is headquartered in Sunnyvale, California [3]

Core Insights - CeriBell, Inc. reported a strong third quarter performance with total revenue of $22.6 million, marking a 31% increase from $17.2 million in the same quarter of 2024, driven by commercial traction and account expansion [4][11] - The company aims to establish point-of-care EEG as a new standard for seizure management, targeting a $2 billion addressable market opportunity [3][4] - CeriBell raised its full-year revenue guidance for 2025 to a range of $87 million to $89 million, indicating a growth of approximately 33% to 36% compared to the previous year [8] Financial Performance - Product revenue for Q3 2025 was $17.0 million, a 28% increase from $13.3 million in Q3 2024, while subscription revenue reached $5.6 million, up 44% from $3.9 million [4][11] - Gross profit for the quarter was $19.9 million, with a gross margin of 88%, slightly up from 87% in Q3 2024 [5][11] - Operating expenses increased by 39% to $34.6 million, primarily due to investments in the commercial organization and increased headcount [6][11] Net Loss and Cash Position - The net loss for Q3 2025 was $13.5 million, or $0.37 per share, compared to a net loss of $10.4 million, or $1.85 per share, in Q3 2024 [7][11] - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $168.5 million [7][11] Market Position and Strategy - CeriBell's focus is on generating robust clinical evidence to support the adoption of its technology in acute care settings [3][4] - The company ended the quarter with 615 total active accounts, reflecting its growing market presence [11]

Company Overview - CeriBell, Inc. is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions [3] - The company has developed the Ceribell System, a novel point-of-care electroencephalography (EEG) platform designed for acute care settings [3] - The Ceribell System combines portable hardware with AI-powered algorithms for rapid diagnosis and continuous monitoring of neurological conditions [3] - The system is FDA 510(k) cleared for indicating suspected seizure activity and is currently used in intensive care units and emergency rooms across the U.S. [3] Financial Results Announcement - CeriBell will release its financial results for the third quarter of 2025 after the close of trading on November 4, 2025 [1] - A conference call to discuss the financial results will begin at 1:30 p.m. PT / 4:30 p.m. ET on the same day [1] Investor Relations - Investors can listen to the conference call by dialing (800) 715-9871 for domestic callers or (646) 307-1963 for international callers, using access code 9394689 [2] - A live and archived webcast of the event will be available in the "Investor Relations" section of the Ceribell website [2]

Core Insights - CeriBell, Inc. has appointed Erica Rogers to its Board of Directors, bringing over 30 years of experience in leading high-growth medical device companies [1][2] - The company aims to expand patient access to timely brain monitoring in acute care settings, leveraging Rogers' expertise in scaling healthcare companies [1][3] Company Overview - CeriBell is a medical technology company focused on transforming the diagnosis and management of serious neurological conditions [5] - The Ceribell System is a point-of-care EEG platform designed for rapid diagnosis and continuous monitoring of patients, currently utilized in over 550 hospitals across the U.S. [5][3] - The system is FDA-cleared for detecting suspected seizure activity and combines portable hardware with AI-powered algorithms [5] Leadership Experience - Erica Rogers previously served as CEO of Silk Road Medical, leading the company from a 25-person startup to a publicly traded entity with over 500 employees and revenue exceeding $175 million [2] - Rogers has held board positions in various healthcare companies, emphasizing innovation and culture [2] Strategic Goals - The appointment of Rogers is seen as pivotal for CeriBell's growth phase, aiming to establish the Ceribell System as the standard of care in brain monitoring [3] - The company is focused on broadening access to its EEG technology to improve patient outcomes in critical care [3]

Core Insights - CeriBell reported Q2 2025 revenue of $21.2 million, a 38.5% increase from $15.3 million in Q2 2024, surpassing analyst expectations of $20.45 million [1][2] - The company experienced a net loss of $13.6 million, widening from $8.9 million in Q2 2024, despite improvements in gross margin to 88% [1][2][8] Financial Performance - Revenue (GAAP) for Q2 2025 was $21.2 million, up 38.5% year-over-year from $15.3 million in Q2 2024 [2] - Earnings per share (EPS, GAAP) were $(0.38), better than the expected $(0.40) and a significant improvement from $(1.61) in Q2 2024, reflecting a 76.4% year-over-year change [2] - Gross margin improved to 88%, up from 86% in Q2 2024, attributed to a higher proportion of subscription revenue [2][6] - Operating expenses increased by 55.6% year-over-year to $33.6 million, primarily driven by sales and marketing costs [2][7] - The net loss widened to $13.6 million, compared to $8.9 million in Q2 2024, although the loss per share showed improvement [2][8] Business Model and Strategy - CeriBell's business model relies on recurring revenue from disposable headbands and subscription fees for its Clarity platform, which provides AI-driven seizure analysis [4] - The company aims to expand its customer base across acute care hospitals and broaden clinical indications for its technology, supported by FDA regulatory clearance [4][12] - As of Q2 2025, CeriBell had 584 active accounts, an increase from 558 at the end of Q1 2025, although the pace of new signings has slowed [5] Product and Market Expansion - The Ceribell System combines rapid EEG hardware with AI algorithms for real-time seizure detection, allowing non-specialists to monitor patients [3][10] - Clarity, the AI platform, recently received FDA clearance for pediatric use, although significant revenue from this segment is not expected until 2025 [11] - CeriBell serves approximately 3% of the U.S. market for rapid EEG monitoring, indicating substantial growth potential [12] Outlook and Guidance - Management raised the revenue outlook for full year 2025 to $85 million to $88 million, reflecting confidence in sustained growth and account expansion [14] - Gross margin is expected to remain in the mid-80% range, with strategies in place to mitigate potential tariff impacts [14][15]

Core Insights - CeriBell, Inc. reported a strong financial performance for Q2 2025, with total revenue reaching $21.2 million, a 38% increase from $15.3 million in Q2 2024, driven by commercial traction and account expansion [3][10] - The company is optimistic about its growth trajectory and plans to enhance its market presence and product pipeline in the second half of 2025 [2] Financial Performance - Total revenue for Q2 2025 was $21.2 million, up 38% from $15.3 million in Q2 2024, with product revenue at $15.9 million (38% increase) and subscription revenue at $5.3 million (41% increase) [3][10] - Gross profit for Q2 2025 was $18.7 million, with a gross margin of 88%, compared to $13.2 million and 86% in Q2 2024 [4][10] - Operating expenses increased by 56% to $33.6 million in Q2 2025, primarily due to investments in the commercial organization and increased headcount [5] - The net loss for Q2 2025 was $13.6 million, or $0.38 per share, compared to a net loss of $8.9 million, or $1.61 per share, in Q2 2024 [6][10] Financial Outlook - CeriBell raised its revenue guidance for the full year 2025 to a range of $85 million to $88 million, indicating a growth of approximately 30% to 34% over the previous year [7] Company Overview - CeriBell is focused on transforming the diagnosis and management of serious neurological conditions through its innovative Ceribell System, which combines portable hardware with AI-powered algorithms for rapid diagnosis and monitoring [12]

Company Overview - Ceribell, Inc. is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions [3] - The company has developed the Ceribell System, a novel point-of-care electroencephalography (EEG) platform designed for acute care settings [3] - The Ceribell System combines portable hardware with AI-powered algorithms for rapid diagnosis and continuous monitoring of neurological conditions [3] - The system is FDA-cleared for detecting suspected seizure activity and is currently used in intensive care units and emergency rooms across the U.S. [3] Upcoming Event - Jane Chao, Ph.D., CEO and Co-founder of Ceribell, will present at the Canaccord Genuity 45 Annual Growth Conference [1] - The presentation is scheduled for Tuesday, August 12, 2025, at 11:00 a.m. Pacific Standard Time / 2:00 p.m. Eastern Standard Time [2] - A live and archived webcast of the presentation will be available on the Ceribell website [2]

Company Overview - CeriBell, Inc. is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions [3] - The company has developed the Ceribell System, a novel point-of-care electroencephalography (EEG) platform designed for acute care settings [3] - The Ceribell System combines portable hardware with AI-powered algorithms for rapid diagnosis and continuous monitoring of neurological conditions [3] - The system is FDA 510(k) cleared for indicating suspected seizure activity and is currently used in intensive care units and emergency rooms across the U.S. [3] Financial Results Announcement - CeriBell will release its financial results for the second quarter of 2025 after the close of trading on August 5, 2025 [1] - A conference call to discuss the financial results will begin at 1:30 p.m. PT / 4:30 p.m. ET on the same day [1] Investor Information - Investors can listen to the conference call by dialing (800) 715-9871 for domestic callers or (646) 307-1963 for international callers, using access code 7468193 [2] - A live and archived webcast of the event will be available in the "Investor Relations" section of the Ceribell website [2]