US-based medical equipment manufacturer Zeto has received the US Food and Drug Administration (FDA) 510(k) approval for its new-generation electroencephalography (EEG) brain monitoring solution.
The new product, dubbed ONE, is a portable EEG device that enables bedside seizure detection, along with video, audio, and live remote monitoring and interpretation.
It includes a user-friendly headset equipped with 21 soft-tip electrodes, which are positioned as per the commonly followed 10-20 EEG system.
The system also features an intuitive LED feedback mechanism for easy adjustments and requires minimal training for any healthcare professional to operate effectively.
Zeto founder and CEO Aswin Gunasekar said: “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.”
According to the medical technology company, EEG needs in the healthcare sector are mostly unmet due to a constant shortage of trained EEG technologists.
The new EEG products needed to be designed in a way that they are easy to handle by any staff, comfortable for the patient and deliver superior signal quality.
Hospitals also need a full-montage EEG for full coverage of clinically significant events, video capabilities to help physicians in interpretation, and diagnostic software for emergencies.
Zeto ONE comes with a portable recording device that captures patient video and audio to provide display and recording controls, along with AI-enabled notifications for seizure activity.
The EEG device easily streams data to the Zeto Cloud, enabling live remote interpretations by board-certified neurologists.
In addition, it serves as a comprehensive EEG platform, enabling multiple tasks such as workflow management, patient scheduling, and report generation, said the medical device firm.
Barrow Neurological Institute department of neurology professor and clinical affairs vice chair Susan Herman said: “Zeto ONE is a breakthrough EEG system, revolutionizing many aspects of emergency EEG acquisition.
“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.”
