Zeto has announced that it received FDA 510(k) clearance for its One product, an advanced EEG brain monitoring device. The Santa Clara-based company has designed One to include a user-friendly headset with 21 soft-tip electrodes arranged according to the 10-20 EEG system, along with intuitive LED feedback for easy adjustments. This device is designed to be operated with minimal training, capturing patient video and audio and offering display and recording controls. It also features live AI-enabled notifications for seizure activity, which are crucial in emergency situations.
The One device seamlessly streams data to Zeto Cloud, enabling live remote interpretations by board-certified neurologists. Beyond its point-of-care capabilities, One serves as a comprehensive EEG platform that supports various functions, including workflow management, patient scheduling, and report generation. This functionality ensures that healthcare providers can manage EEG data efficiently and effectively.
According to Zeto founder and CEO Aswin Gunasekar, One is the culmination of over eight years of customer-focused product development. The device builds on the success of their first-generation Wrap (WR19) headset and aims to democratize access to continuous EEG brain monitoring and diagnostics. Gunasekar anticipates that One will significantly advance EEG monitoring in critical care, outpatient, and home settings, providing a more accessible and reliable solution for brain monitoring.
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