Ceribell’s System Receives Breakthrough Device Designation for Delirium

Ceribell has received from the FDA Breakthrough Device designation for its delirium-indicated system. Delirium is also known as acute brain failure and is a sign of ongoing brain injury.

The Ceribell system is said to use machine learning to analyze electroencephalography signals to detect delirium.

The system also analyzes electroencephalography waveform data for evidence of delirium, enabling potential earlier and better detection as well as continuous monitoring to improve patient care and outcomes, the company said.

The designation is supported by early clinical studies that show the system’s likelihood to improving the current standard of care.