MetaMedical™ Solutions Inc

Zeto wins FDA clearance for ONE EEG system  

US-based medical equipment manufacturer Zeto has received 510(k) clearance from the Food and Drug Administration (FDA) for its electroencephalogram (EEG) system Zeto ONE across hospital, home, ambulance and air transport environments. 

The Zeto ONE consists of a headset with 21 soft-tip electrodes positioned according to the 10-20 EEG system – an internationally recognised method that allows EEG electrode placement to be standardised.

According to the company, it requires minimal training and captures patient video and audio, offering live AI-enabled seizure notifications. Data is streamed to the Zeto Cloud allowing live remote interpretations by neurologists. 

The system also functions as a comprehensive EEG platform, supporting workflow management, patient scheduling, and report generation. EEG is a medical test used to measure the electrical activity of the brain. It can help to diagnose several conditions, including epilepsy, sleep disorders and brain tumours. 

Founded in 2014, the Santa Clara-based company raised $7.3m in Series A funding back in 2020. The funding round was led by Seraph Group with participation from Aphelion Capital, SV Tech Ventures, and Shangbay Capital. 

Its first wireless, dry-electrode EEG headset WR19 was approved by the FDA for clinical use in 2020. Zeto performed three clinical studies across 50 subjects that showed signal quality is on par with FDA-cleared traditional EEG systems. The studies involved simultaneous recordings of subjects with WR19 and Clinical EEG (cEEG) electrodes placed about 1cm-2cm from each other. 

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In the announcement accompanying the clearance, Zeto CEO Aswin Gunasekar said: “As our first-generation Wrap (WR19) headset sees increasing adoption for short-term EEGs, ONE strengthens our portfolio by democratising access to continuous EEG brain monitoring and diagnostics. We anticipate ONE to notably advance EEG monitoring in critical care, outpatient and home settings.”  

This isn’t the first digital health company focused on EEGs. In January 2024, US-based Gate Neurosciences partnered with Beacon Biosignals to use EEG biomarkers in developing its neuropsychiatry and cognition clinical pipeline. Last month, Soterix Medical announced the launch of the MxN-GO EEG system that integrates high-definition transcranial electrical stimulation (HD-tES) with EEG capabilities. 

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