Ceribell Secures CMS NTAP Reimbursement for First FDA-Cleared Point-of-Care Delirium Monitor
核心洞察
CMS has granted a New Technology Add-On Payment of up to $2,171 per eligible Medicare case for the Ceribell Delirium Monitor System (搜索), effective October 1, 2026.
The Ceribell Delirium Monitor System (搜索) is the first and only FDA-cleared device for aiding in delirium (搜索) screening and monitoring, receiving 510(k) clearance in December 2025.
The system continuously analyzes automated EEG segments and uses AI to notify clinicians upon detecting patterns associated with delirium (搜索), enabling rapid and objective treatment decisions.
SUNNYVALE, Calif. — CeriBell (搜索), Inc. (Nasdaq: CBLL) announced on August 3, 2026, that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted a New Technology Add-On Payment (NTAP) for up to $2,171 per eligible Medicare patient case utilizing the Ceribell Delirium Monitor System (搜索). The add-on payment is set to take effect on October 1, 2026, under the Medicare Hospital Inpatient Prospective Payment System (IPPS).
This regulatory milestone follows the December 2025 U.S. Food and Drug Administration (FDA) 510(k) clearance of Ceribell (搜索)'s proprietary Delirium (搜索) Monitor System, which established it as the first and only FDA-cleared device used to aid in delirium screening and monitoring.
A Unified Platform for Neurological Monitoring
The Ceribell Delirium Monitor System (搜索) continuously analyzes automated electroencephalogram (EEG) segments, notifying clinicians upon detecting patterns associated with delirium (搜索) to support rapid and objective treatment decision-making. Built on Ceribell (搜索)'s existing FDA-cleared technology for detecting nonconvulsive seizures (搜索) and electrographic status epilepticus (搜索) (ESE), the unified platform seamlessly integrates both seizure and delirium monitoring into a single system. By tracking multiple neurological vital signs simultaneously at the bedside, Ceribell equips providers with comprehensive diagnostic insights to manage co-occurring brain risks without requiring separate devices.
"We believe that CMS' NTAP decision underscores the profound clinical necessity and transformative value of our point-of-care technology for critically ill patients," said Jane Chao, Ph.D., co-founder and CEO of Ceribell (搜索). "The add-on payment will help facilitate widespread commercial access to this vital innovation for a highly vulnerable patient population. This marks a pivotal milestone in our strategic mission to establish EEG as an essential new vital sign for better brain care."
Clinical Evidence Supporting AI-Powered EEG
The NTAP decision arrives on the heels of compelling clinical evidence reinforcing the value of Ceribell (搜索)'s AI-powered platform. A landmark study published in Critical Care Medicine (CCM), the official peer-reviewed journal of the Society of Critical Care Medicine (SCCM), demonstrated that Ceribell's Clarity AI algorithm measure of seizure burden is correlated with patient functional outcomes at discharge.
The study analyzed data from 359 adult patients across three academic sites — Yale School of Medicine, Massachusetts General Hospital, and The University of New Mexico School of Medicine. Key findings revealed that patients with a peak 5-minute seizure burden greater than or equal to 90% at any point during EEG monitoring were 3.4 times more likely to experience death or severe disability, as measured by a modified Rankin Scale (mRS) score equal to or higher than four, at discharge compared to patients with 0% seizure burden.
Furthermore, each additional hour of Clarity-assessed seizure in the EEG recording was associated with nearly a two-fold increase in risk of severe disability or death (adjusted odds ratio = 1.98).
"For the first time, physicians can directly and continuously monitor seizure burden — a key metric relevant to patient outcomes that was previously inaccessible in real time," said Dr. Chao. "This represents a fundamental shift from indirect or delayed and sporadic assessment toward continuous brain monitoring that leads to informed decision-making at the bedside."
Josef Parvizi, M.D., Ph.D., co-founder, board member and Chief Medical Adviser of Ceribell (搜索), and lead author of the paper, added: "This research confirms that Ceribell's Clarity AI algorithm is detecting biomarkers of a disease state that are clinically relevant, providing a window into the patient's prognosis. Intervening faster to reduce seizure burden, as measured by Clarity, may potentially alter the trajectory of a patient's recovery."
Expanding Access Through Reimbursement
CMS established the NTAP process to identify and ensure adequate payment for certain new medical services and technologies. With the addition of the NTAP for delirium (搜索) monitoring, the Ceribell (搜索) Point-of-Care EEG platform now offers expanded coverage for critically ill patients in intensive care units and emergency rooms across the United States. The Ceribell System combines proprietary, highly portable, and rapidly deployable hardware with sophisticated AI-powered algorithms to enable rapid diagnosis and continuous monitoring of patients with neurological conditions.