Ceribell Inc. Receives FDA Breakthrough Device Designation for Delirium Indication

Ceribell Inc. has received Breakthrough Device Designation for its delirium indication from the United States Food and Drug Administration (FDA).
 
The Ceribell system utilizes machine learning to analyze electroencephalography (EEG) signals to detect delirium. It first received FDA 510(k) clearance in 2017 for indicating suspected seizure activity and is currently utilized in intensive care units (ICUs) and Emergency Rooms across the United States. 
 
Referred to as “acute brain failure,” delirium is sometimes the only indicator of ongoing brain injury. Affecting more than seven million hospitalized Americans annually, failure to diagnose delirium has been associated with a two-fold increase in six-month mortality¹. The current standard of care for diagnosing delirium in the ICU involves a bedside assessment typically performed by a nurse or physician every four to twelve hours. In studies evaluating current practices for recognizing delirium in critical care settings, over half of patients with delirium were not correctly diagnosed².
 
“In many real-world clinical settings delirium assessments are inconsistently implemented resulting in low sensitivity,” stated Dr. Tim Girard, professor of Critical Care Medicine at University of Pittsburgh and co-lead of the study. “A highly reliable, automated approach to delirium diagnosis is greatly needed for this vulnerable patient population.” 
 
“The development of delirium has been associated with increased morbidity and mortality, increased cost of care as well as poor functional and cognitive recovery,” said Dr. Jose Maldonado, professor of Psychiatry at Stanford University, the other co-lead investigator for Ceribell’s delirium trial. “Clinicians must do everything possible to prevent delirium’s occurrence 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 continuous monitoring to improve patient care and outcomes. The Ceribell system’s Breakthrough Device Designation was grounded in early clinical studies that have provided clear evidence that the system is likely to improve the current standard of care. Ceribell is the first and only device to have received an FDA Breakthrough Designation for the screening and monitoring of delirium.
 
“Delirium happens frequently in the ICU and often remains under-diagnosed and under-treated. We are excited to provide a tool that empowers bedside nurses and physicians to manage this challenging disease state with more precision,” said Jane Chao, PhD, Ceribell’s co-founder and CEO. “Modern critical care is moving beyond not only saving a life but also protecting the brain for a higher quality life as well.”

References:
¹ R. Kakuma et al., “Delirium in Older Emergency Department Patients Discharged Home: Effect on Survival.” J American Geriatric Soc 2003; 51.  
² M.M. van Eijk et al., (2011). “Routine Use of the Confusion Assessment Method for the Intensive Care Unit.” Am J Respir Crit Care Med  184.