CeriBell, Inc.

Ceribell Receives FDA 510(k) Clearance for Quantitative EEG Trending and Amplitude-Integrated EEG Analysis

Ceribell received FDA 510(k) clearance for new software adding quantitative EEG trending and amplitude-integrated EEG analysis to the Ceribell System. The update adds three capabilities — ADR/RA trending for brain distress detection, burst suppression monitoring for sedation management, and aEEG for neonatal assessment — with no age restriction, spanning NICU to adult ICU and emergency settings. Features will be delivered via an automatic software update in the first half of 2027, building on recent clearances for neonatal seizure detection and delirium monitoring.

•1mo ago

Ceribell Reports Second Quarter 2026 Financial Results

Ceribell reported Q2 revenue of $28.1 million, up 33% year-over-year, driven by a 33% increase in product revenue and 30% growth in subscription revenue. The company achieved a 92% gross margin and strengthened its balance sheet with a new $60 million credit facility, while securing FDA 510(k) clearances for new algorithms and hardware. Management raised full-year 2026 revenue guidance to $114 million to $117 million, reflecting accelerating adoption across new and existing accounts.

•2mo ago

Ceribell Receives FDA Clearance for Advanced Epileptiform Abnormality Detection and Artifact Reduction for Its Cloud-Based Portal, Delivering Greater Precision for Critical-Care EEG Review

CeriBell received FDA 510(k) clearance for two AI-driven enhancements—Epileptiform Abnormality Detection and Artifact Reduction—for its cloud-based Neurology Portal. These new algorithms are designed to filter background interference and highlight specific abnormalities, accelerating review times for neurologists in critical-care settings. The update builds on the company's existing point-of-care system and leverages a database of more than one million hours of EEG data to improve diagnostic confidence.

•2mo ago

Ceribell Secures CMS New Technology Add-On Payment (NTAP) for Breakthrough Point-of-Care Delirium Monitor System

Ceribell secured a New Technology Add-On Payment (NTAP) from CMS for up to $2,171 per eligible Medicare patient case utilizing its Delirium Monitor System. This reimbursement milestone, effective October 1, 2026, follows the device's FDA 510(k) clearance in December 2025 and is designed to ensure adequate payment for the new technology under the Medicare Hospital Inpatient Prospective Payment System. CEO Jane Chao stated the decision underscores the clinical necessity of the technology and facilitates widespread commercial access for critically ill patients.

•2mo ago

Ceribell Expands Board of Directors with Appointments of Thomas West and Sharon O’Keefe

Ceribell appointed Thomas West and Sharon O’Keefe to its Board of Directors, adding deep commercial and health-system leadership expertise as the company expands adoption of its point-of-care brain monitoring platform. West brings significant experience scaling medical technologies, having served as CEO of Nalu Medical and Intersect ENT prior to their acquisitions by Boston Scientific and Medtronic for $600 million and $1.1 billion, respectively. O’Keefe contributes extensive operational leadership from her tenure as President of the University of Chicago Medical Center, where she oversaw more than $2 billion in annual operating revenue. Ceribell’s platform is currently deployed in over 680 U.S. hospitals.

•3mo ago

Ceribell Announces New Critical Care Medicine Publication Reinforcing Link Between Seizure Burden Measured by Clarity AI Algorithm and Neurological Outcomes

Ceribell announced the publication of a new study in Critical Care Medicine validating its Clarity AI algorithm. The study of 359 patients found that higher seizure burden detected by Clarity correlates with severe disability or death, with a 3.4x increased risk for patients with high seizure burden. Each additional hour of seizure activity was associated with a nearly two-fold increase in risk, reinforcing the clinical utility of continuous monitoring.

•4mo ago