FDA Greenlights Zeto's Dry Electrode, Wireless EEG Headset for Clinical Use

Zeto, Inc. has announced that the US Food and Drug Administration (FDA) approved its dry electrode EEG headset, zEEG, for use in clinical setting.

This is the first FDA approved dry electrode EEG headset backed by a cloud platform offering instant upload, tools for analysis and remote interpretation by neurologists.

“EEG is a critically important test for evaluation of patients with seizures or unexplained confusion that might be due to subtle seizures. Unfortunately, EEG technology has not evolved much since its inception almost 100 years ago, leaving EEG underutilized for neurological conditions,” Robert Fisher, MD, PhD, director, Stanford Epilepsy Center, former President of the American Epilepsy Society, said in a statement. “The zEEG technology will allow diagnosis and testing in hospitals and clinics that could not previously perform EEGs. This will be a very significant advance.”

The approval is backed by a clinical study that showed the headset to provide EEG signal quality that was comparable to an approved, traditional EEG system. The study was conducted on 30 patients in 2 study cohorts—EEG patients and healthy volunteers— for up to 2 hours. Researchers concluded that the device performed at least as well as the reference device based on predefined acceptance criteria.

Study results will be published in the coming months.

EEG is instantly uploaded to the cloud where physicians can use a laptop, tablet or smartphone to analyze live or recorded EEG.

The FDA approved the Zeto EEG system in April and will continue to work with hospital beta customers in preparation for a commercial launch later this year.

“With the approval of zEEG, health care professionals and patients now have access to an EEG system that provides a simple, easy and convenient experience with the benefit of quick and smart analysis of data through our cloud platform,” Aswin Gunasekar, MS, MBA, chief executive officer, founder, Zeto, said in a statement.