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December 18, 2025
2 min read
Key takeaways:
- The device is the first to gain FDA clearance to monitor delirium.
- The device’s algorithm was validated with data from prospective clinical trials of adults treated in critical care environments.
The FDA has granted 510(k) clearance to a Bay Area medical technology firm for its proprietary delirium monitoring solution, the first and only such device to receive FDA clearance, according to the manufacturer.
Ceribell Inc. said the approval positioned its AI-powered device as the first and only FDA-cleared screening and monitoring method tailored to individuals requiring hospitalization for neurological conditions, the company said in a press release.
Action by the FDA paves the way for clinicians to have a reliable method of screening for and tracking the condition in those requiring hospitalization for neurologic conditions.
This clearance followed prior receipt of breakthrough device designation for delirium monitoring in 2022. In late 2023, Ceribell announced commercialization of a similar AI-based platform for continuously monitoring brain activity of those with electrographic status epilepticus.
Subsequent to the current FDA clearance, Ceribell also submitted a New Technology Add-on Payment application to CMS for the new indication.
“Delirium is an underserved and frequently under-recognized condition affecting a meaningful portion of critically ill patients in the ICU,” Jane Chao, PhD, cofounder and CEO of Ceribell, told Healio. “When delirium is not accurately identified and addressed early, it results in worse outcomes and longer hospital stays.”
Further, the newly approved technology continuously analyzes EEG segments and notifies clinicians when patterns associated with delirium are detected. This, Chao added, enables more timely, reliable and consistent evaluation and management of delirium.
Jane Chao
Ceribell’s delirium algorithm was validated using EEG data and clinical assessments collected through prospective studies that included 225 adults aged 22 years and older who required medical assistance in critical care environments.
According to statistics cited from prior research in the release, delirium impacts approximately 31% of all ICU patients and up to 80% of those who require mechanical ventilation.
Further, per the release, delirium is associated with a 10% higher 6-month mortality risk for every day it is experienced, as well as a 60% higher risk of post-ICU dementia.
Additional statistics cited in the release from previous research revealed that approximately 48% of all individuals who experience seizures in the ICU also experience delirium around the time of the seizure, with another study citing epileptiform discharges in 42% of older ICU patients with delirium.
“The new FDA clearance further establishes the Ceribell system as an AI-powered brain monitoring platform technology, extending beyond detection of seizures and electrographic status epilepticus to now include delirium,” Chao told Healio.
For more information:
Jane Chao, PhD, can be reached at psychiatry@healio.com.
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