Ceribell System
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Ceribell to Participate in Upcoming March Investor Conferences
Globenewswire· 2026-02-18 21:05
Core Insights - CeriBell, Inc. is participating in two upcoming investor conferences to enhance investor engagement and showcase its innovative medical technology solutions [1][2]. Group 1: Upcoming Events - CeriBell will present at the Raymond James 47 Annual Institutional Investors Conference on March 2, 2026, at 1:00 p.m. PST / 4:00 p.m. EST [2]. - The company will also participate in a fireside chat at the TD Cowen 46 Annual Health Care Conference on March 3, 2026, at 10:50 a.m. PST / 1:50 p.m. EST [2]. Group 2: Company Overview - CeriBell is focused on transforming the diagnosis and management of patients with serious neurological conditions through its innovative Ceribell System [3]. - The Ceribell System is a point-of-care electroencephalography (EEG) platform designed for acute-care settings, enabling rapid diagnosis and continuous monitoring of neurological conditions [3]. - The system is FDA-cleared for detecting seizures and delirium in intensive care units and emergency rooms across the U.S. [3].
Ceribell to Report Fourth Quarter and Full Year 2025 Financial Results on February 24, 2026
Globenewswire· 2026-02-10 21:05
Core Viewpoint - CeriBell, Inc. is set to release its financial results for Q4 and the full year of 2025 on February 24, 2026, with a conference call scheduled to discuss these results [1]. 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 seizures and delirium in intensive care units and emergency rooms across the U.S. [3]. - CeriBell is headquartered in Sunnyvale, California [3].
Ceribell Receives FDA Breakthrough Device Designation for LVO Stroke Detection and Monitoring Solution
Globenewswire· 2026-01-05 13:00
Core Insights - Ceribell, Inc. has received Breakthrough Device Designation from the FDA for its Large Vessel Occlusion (LVO) stroke detection monitor, which utilizes AI algorithms to interpret EEG signals for early detection of LVO strokes in hospital settings [1][2][3] Group 1: Product Development and Innovation - The LVO stroke detection monitor is a first-in-class device that builds on Ceribell's existing hardware and aims to improve the diagnosis and management of serious neurological conditions [1][7] - This designation follows recent FDA clearances for Ceribell's Clarity® algorithm for detecting electrographic seizures in neonates and a proprietary delirium screening solution [2] Group 2: Market Need and Impact - Approximately 800,000 strokes occur annually in the U.S., with LVO strokes contributing to about 62% of post-stroke dependence and 96% of post-stroke mortalities, highlighting the critical need for timely detection [3] - In-hospital strokes, which account for up to 17% of all strokes, often experience significant delays in detection and treatment, leading to worse outcomes compared to community-onset strokes [3][4] Group 3: Clinical Significance - Timely detection of LVO strokes can significantly improve patient outcomes, with every minute saved correlating to a week of disability-free life [3] - The Breakthrough Device Designation underscores the potential of Ceribell's technology to provide accurate and timely detection, which is crucial for vulnerable patient populations [3][2]
Ceribell to Participate in the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2025-12-30 21:05
Core Viewpoint - CeriBell, Inc. is set to present at the 44th Annual J.P. Morgan Healthcare Conference, highlighting its focus on transforming the diagnosis and management of serious neurological conditions [1][2]. Group 1: Company Overview - CeriBell, Inc. is a medical technology company dedicated to improving 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 seizures and delirium in intensive care units and emergency rooms across the U.S. [3]. Group 2: Upcoming Event - Jane Chao, Ph.D., CEO and Co-founder of CeriBell, will present at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, at 9:00 am PST / 12:00 pm EST [1][2]. - A live and archived webcast of the presentation will be available in the "Investor Relations" section of the Ceribell website [2].
Ceribell Receives FDA 510(k) Clearance for First-of-its-Kind Delirium Monitoring Solution
Globenewswire· 2025-12-09 13:00
Core Insights - CeriBell, Inc. has received FDA 510(k) clearance for its proprietary delirium monitoring solution, marking it as the first and only FDA-cleared device for delirium screening and monitoring [1][3] - The Ceribell System is an AI-powered brain monitoring platform that aims to improve the diagnosis and management of critically ill patients at risk for seizures and delirium [1][6] Company Overview - CeriBell is a medical technology company focused on transforming the diagnosis and management of serious neurological conditions, specifically through its point-of-care electroencephalography (EEG) platform [9] - The company has developed a system that combines portable hardware with AI algorithms for rapid diagnosis and continuous monitoring of neurological conditions [9] Industry Context - Delirium affects approximately 31% of ICU patients and up to 80% of mechanically ventilated patients, leading to increased mortality and longer hospital stays [4] - The risk of post-ICU dementia is 60% higher in patients who experienced delirium compared to those who did not, highlighting the need for effective monitoring solutions [4] Technological Validation - The delirium algorithm was validated through rigorous studies involving 225 adults in critical care settings, demonstrating its reliability for continuous monitoring [3] - The FDA clearance follows the Breakthrough Device Designation received in 2022, indicating the technology's potential impact on patient care [3] Clinical Implications - Current methods for detecting delirium are labor-intensive and subject to human variability, while CeriBell's solution offers continuous monitoring that can improve detection rates and management [2][4] - Studies indicate a significant relationship between seizures and delirium, with the Ceribell System designed to monitor both conditions simultaneously, aiding clinical decision-making [5]
Ceribell Receives FDA 510(k) Clearance for Use of ClarityⓇ Algorithm for Neonates
Globenewswire· 2025-11-24 13:00
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]
Ceribell to Participate in the Piper Sandler 37th Annual Healthcare Conference
Globenewswire· 2025-11-19 21:05
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]
Ceribell Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-11-04 21:05
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]
Ceribell to Report Third Quarter 2025 Financial Results on November 4, 2025
Globenewswire· 2025-10-21 20:05
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]
Medtech Leader Erica Rogers Joins Ceribell Board of Directors
Globenewswire· 2025-09-22 12:00
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]