FDA Approves Advanced EEG Brain Monitoring System, Zeto ONE


Zeto has achieved a significant milestone with 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its advanced Electroencephalography (EEG) brain monitoring device, the Zeto ONE. This cutting-edge product features a user-friendly headset equipped with 21 soft-tip electrodes following the standard 10-20 EEG system, complemented by intuitive LED indicators for effortless adjustments. Designed for ease of use, the Zeto ONE requires minimal training for healthcare professionals, offering a portable recording device that captures video and audio, alongside live AI-enabled alerts for seizure activity, which is crucial for emergency scenarios. Data is seamlessly streamed to the Zeto Cloud, enabling real-time remote interpretation by certified neurologists and supporting comprehensive EEG functionalities such as workflow management, scheduling, and report generation.

Aswin Gunasekar, Founder and CEO of Zeto, emphasized the ONE’s development as a culmination of eight years of dedicated customer-focused innovation. He highlighted its role in democratizing continuous EEG monitoring and diagnostics, complementing their existing Wrap (WR19) headset used for short-term EEGs. Gunasekar anticipates significant advancements in EEG monitoring across critical care, outpatient, and home settings with the introduction of the ONE.

Dr. Susan Herman, from Barrow Neurological Institute, lauded the Zeto ONE as a groundbreaking system that revolutionizes emergency EEG procedures. She noted its pivotal role in addressing resource limitations in hospitals by offering a streamlined application of full 10-20 electrodes, coupled with video and audio recording capabilities, AI-based triage tools, and seamless connectivity for neurologist interpretation. This integration promises enhanced workflow efficiency, ensuring accurate EEG interpretations crucial for critically ill patients.


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