Ceribell Receives Breakthrough Device Designation from the FDA for Delirium Indication


The Breakthrough Device designation recognizes Ceribell’s point-of-care EEG as a first-of-its-kind technology for the detection of delirium.

SUNNYVALE, Calif., September 8, 2022 /PRNewswire/ — Ceribell, Inc. today announced that it has received Breakthrough Device Designation for its delirium indication from the United States Food and Drug Administration (FDA). A first-of-its-kind technology, the Ceribell® System uses machine learning to analyze electroencephalography (EEG) signals to detect delirium. The Ceribell Point-of-Care EEG System first received 510(k) clearance from the FDA in 2017 to indicate suspected seizure activity and is currently used in intensive care units (ICUs) and wards. emergency across the United States.

Called “acute cerebral failure,” delirium is sometimes the only indicator of ongoing brain damage. Affecting more than seven million Americans hospitalized each year, undiagnosed delirium has been associated with a two-fold increase in six-month mortality1. The current standard of care for diagnosing delirium in the intensive care unit involves a bedside assessment typically performed by a nurse or physician every four to twelve hours. In studies evaluating current delirium recognition practices in intensive care settings, more than half of patients with delirium were not correctly diagnosed.2.

“In many real-world clinical settings, assessments of delirium are implemented inconsistently, resulting in low sensitivity,” said Dr. Tim GirardProfessor of Critical Care Medicine at University of Pittsburgh and study co-lead, “A highly reliable and automated approach to the diagnosis of delirium is badly needed for this vulnerable patient population.”

“The development of delirium has been associated with increased morbidity and mortality, increased cost of care, and poor functional and cognitive recovery,” said Dr. Jose Maldonadoprofessor of psychiatry at Stanford Universitythe other co-principal investigator of the Ceribell delirium trial, “Clinicians should do everything possible to prevent the onset of delirium or shorten its duration by recognizing its symptoms early.”

Ceribell’s system analyzes EEG waveform data for evidence of delirium, enabling potential earlier and better detection as well as ongoing monitoring to improve patient care and outcomes. The Breakthrough Device designation of the Ceribell System was based on early clinical studies which provided clear evidence that the system has the potential to improve the current standard of care. The Breakthrough Devices program aims to give patients and healthcare providers expedited access to new technologies that can treat or diagnose debilitating conditions by expediting FDA review of devices with this designation. Ceribell is the first and only device to receive breakthrough FDA designation for delirium screening and monitoring.

“Delirium occurs frequently in intensive care and often remains underdiagnosed and undertreated. We are excited to provide a tool that allows bedside nurses and physicians to manage this challenging disease state with more precision,” said Jane ChaoPhD, co-founder and CEO of Ceribell, “Modern critical care goes beyond not just saving a life, but also protecting the brain for a higher quality life.”

About Ceribell

Ceribell, Inc. (www.ceribell.com), is headquartered in Sunnyvale, California. Ceribell is deploying a portable, cloud-linked electroencephalogram (EEG) device to assess brain waves in minutes to identify seizure occurrence in emergency rooms and intensive care units. The Ceribell System can be quickly and easily applied to a patient by any healthcare provider and provides brain monitoring results in minutes. Ceribell is focused on making EEG widely available, more efficient and more cost-effective to improve the diagnosis and treatment of neurological conditions in patients at risk for seizures. The Ceribell EEG System first received 510(k) clearance from the FDA in 2017 and is commercially available in the United States.

[1] R. Kakuma et al., “Delirium in elderly emergency department patients discharged home: effect on survival.” J American Geriatric Society 2003; 51.

M. M. van Eijk et al., (2011). “Routine Use of the Confusion Assessment Method for the Intensive Care Unit.” Am J Respir Crit Care Med184.

SOURCECeribell, Inc.


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