FDA OKs Zeto’s Next-Gen ONE EEG Brain Monitor

Zeto has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-gen ONE electroencephalography (EEG) brain monitor.
 
ONE is comprised of a user-friendly headset with 21 soft-tip electrodes positioned according to the 10-20 EEG system. It also has LED feedback for easy adjustments.
 
The company said it only needs minimal training to operate effectively. The portable recording devices captures patient audio and video for display and recording controls. It also offers live, artificial intelligence (AI)-enabled notifications for seizure activity.
 
ONE streams its data to the Zeto Cloud so board-certified neurologists can interpret the data remotely. Adding to its role as a point-of-care system, it also serves as a comprehensive EEG platform. This enables workflow management, patient scheduling, and report generation.
 
“Zeto ONE is a breakthrough EEG system, revolutionizing many aspects of emergency EEG acquisition,” said Susan Herman, MD, Professor and Vice Chair of Clinical Affairs, Department of Neurology at Barrow Neurological Institute. “We know that up to 40% of brain injured emergency department and intensive care patients may experience seizures, which are often subclinical and require EEG for diagnosis. ONE fills a gap for hospitals that lack EEG resources—provides streamlined point-of care application of full 10-20 electrodes, video and audio recording, AI triage tools, and efficient connectivity to the interpreting neurologist. This enhanced workflow ensures that EEGs have high technical quality and accurate interpretations in our most critically ill patients.”
 
“Breakthrough changes arise from the cumulative effect of years of gradual improvements,” added Zeto founder and CEO Aswin Gunaseka. “ONE is a culmination of 8+ years of customer centric product development by our industrious team. 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.”