Headset for EEG-Assessment of Seizure Activity Cleared by FDA

The Food and Drug Administration (FDA) has granted 510(k) clearance to ONE (Zeto, Santa Clara, CA), a headset that records electroencephalography (EEG) signals and other patient data using artificial-intelligence (AI)–based triage tools to monitor seizure activity in critical or emergency care settings. ONE is intended to be used at point-of-care, assisting hospitals that lack EEG resources and enhancing treatment and diagnosis for people with brain injury.

According to a statement provided by Zeto, ≤40% of people with a brain injury who are in the emergency department or intensive care setting experience seizure, which may be subclinical and undiagnosable without EEG. ONE is intended to fill a gap for hospitals that lack EEG equipment and to enhance the efficiency of EEG-data collection for hospitals that do have this equipment.

ONE consists of a headset with 21 soft-tipped electrodes, which is designed for easy application and adjustment with elastic straps and an LED feedback system. The system also records audio and video of the patient, transmitting data to the Zeto Cloud for live remote assessment by board-certified neurologists. ONE provides AI-enabled notifications for seizure activity and encompasses a platform for managing workflows, scheduling patients, and generating reports. According to Zeto, medical professionals require minimal training to be able to use ONE effectively.  

“Many hospitals in the world have no ability to obtain EEGs,” said Robert S. Fisher, MD, PhD, Director of the Stanford Epilepsy Center and former President of the American Epilepsy Society (AES). “Zeto ONE will make it possible for them to do so. For hospitals and offices with EEG capabilities, ONE will make obtaining the EEG more efficient for the medical personnel and more comfortable for the patients.”