FDA OKs First Dry Electrode, Wireless EEG Headset for Clinical Use

Zeto Inc., a privately held medical technology company transforming the way electroencephalography (EEG) is done at hospitals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its dry electrode EEG headset, called zEEG, for use in the clinical setting. The zEEG is the first FDA approved dry electrode EEG headset backed by a cloud platform that offers 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,” said Robert S. Fisher, M.D., Ph.D., Director of the Stanford Epilepsy Center and former President of the American Epilepsy Society. “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.”
 
“With the approval of zEEG, healthcare 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,” said Aswin Gunasekar, MS, MBA, CEO and Founder of Zeto Inc. “Our goal was to find a technology that would not only democratize access to EEG with a seamless platform but also unlock the potential of AI, opening up significant opportunities for conditions such as epilepsy, stroke, concussion and sleep disorders. We are proud to have developed a solution that presents a paradigm shift for EEG.”
 
A clinical study demonstrated that the zEEG headset provided EEG signal quality that was comparable to an approved, traditional EEG system. 30 patients in two study cohorts (EEG patients and healthy volunteers) were studied for specific time periods (up to 2 hours), and the zEEG was found to perform at least as well as the reference device based on predefined acceptance criteria. Study results will be published in the coming months.
 
“This approval is particularly meaningful to the Epilepsy Foundation, since the zEEG system was selected as the winner of the 2016 Epilepsy Foundation Shark Tank and was also awarded a New Therapy Commercialization Investment in 2017,” said Jacqueline French M.D., chief scientific officer of the Epilepsy Foundation and Professor of Neurology, NYU Langone Health’s Comprehensive Epilepsy Center. “We saw a great potential for the electroencephalogram, an old diagnostic technique, to take a great leap into the modern age, making it more accessible for diagnosis of epilepsy.”
 
The FDA approved the Zeto EEG system in April 2018. Zeto plans to continue working with leading hospital beta customers in preparation for a commercial launch later in the year.