Zeto announced received FDA 510(k) clearance for its One product for electroencephalography (EEG) brain monitoring. Santa Clara, California-based Zeto designed One to feature a user-friendly headset equipped with 21 soft-tip electrodes positioned according to the commonly followed 10-20 EEG system. Intuitive LED feedback accompanies the headset for easy adjustments as well.
Related: FDA clears InnoVoyce’s VYLO Laser System for medical use
One requires minimal training for healthcare professionals to operate effectively. The portable recording device captures patient video and audio and offers display and recording controls. It also features live, AI-enabled notifications for seizure activity which can prove crucial in critical emergency scenarios.
Zeto says One seamlessly streams data to its Zeto Cloud, enabling live remote interpretations by board-certified neurologists. On top of point-of-care capabilities, One serves as a comprehensive EEG platform, Zeto noted. It enables various tasks, including workflow management, patient scheduling and report generation.
“Breakthrough changes arise from the cumulative effect of years of gradual improvements,” said Zeto founder and CEO, Aswin Gunasekar. “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.”
