The headset is cleared for electroencephalography brain monitoring across hospital, home, ambulance, and air transport environments.


Summary: The US Food and Drug Administration has granted 510(k) clearance to Zeto Inc’s next-generation electroencephalography (EEG) brain monitoring device, ONE, for use in various settings including hospitals, homes, ambulances, and air transport. The device, which features 21 soft-tip electrodes, AI-enabled notifications, and remote data streaming to the Zeto Cloud, aims to enhance accessibility and efficiency in EEG monitoring and diagnostics.

Key Takeaways:

  • Zeto Inc’s EEG monitoring device, ONE, has received 510(k) clearance from the FDA for use across multiple environments, including hospitals, homes, ambulances, and air transport.
  • ONE is equipped with 21 soft-tip electrodes, LED feedback for adjustments, AI-enabled seizure notifications, and capabilities for live remote interpretations via the Zeto Cloud, designed to be intuitive and require minimal training for healthcare professionals.
  • By democratizing access to continuous EEG monitoring, ONE aims to improve critical care, outpatient, and home EEG diagnostics, making EEGs more accessible and efficient for medical personnel and more comfortable for patients.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Zeto Inc’s next-generation product, ONE, for electroencephalography (EEG) brain monitoring across hospital, home, ambulance, and air transport environments.

ONE consists of a headset equipped with 21 soft-tip electrodes positioned according to the commonly followed 10-20 EEG system, accompanied by LED feedback for easy adjustments. According to a release from Zeto, the device is intuitive and requires minimal training for any healthcare professional to operate effectively. 

The portable recording device captures patient video and audio, offering display and recording controls, as well as live, artificial intelligence (AI)-enabled notifications for seizure activity. ONE streams data to the Zeto Cloud, enabling live remote interpretations. In addition to its role as a point-of-care system, it serves as a comprehensive EEG platform, enabling various tasks such as workflow management, patient scheduling, and report generation.

Enhancing Accessibility and Efficiency

Zeto ONE Photo credit: Zeto Inc

“Breakthrough changes arise from the cumulative effect of years of gradual improvements. ONE is a culmination of eight-plus years of customer-centric product development by our industrious team,” says Zeto’s Founder and CEO Aswin Gunasekar in a release. “As our first-generation Wrap (WR19) headset sees increasing adoption for short-term EEGs, ONE strengthens our portfolio by democratizing access to continuous EEG brain monitoring and diagnostics. We anticipate ONE to notably advance EEG monitoring in critical care, outpatient and home settings.”

Robert S. Fisher, MD, PhD, director of the Stanford Epilepsy Center and former president of the American Epilepsy Society, adds in a release, “Many hospitals in the world have no ability to obtain EEGs. 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.”

Zeto ONE is now available for sale.

Photo caption: Zeto ONE

Photo credit: Zeto