Zeto Secures FDA Clearance for Next-Generation EEG Brain Monitoring Device

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The FDA has granted 510(k) clearance to the ZETO ONE, an innovative next-generation EEG Brain Monitoring product. Zeto’s Founder, Aswin Gunasekar, is a 2017 Rosenman Innovator.

From the press release:

SANTA CLARA, Calif., June 4, 2024 /PRNewswire/ — Zeto, Inc., a privately owned medical technology company, has announced that its innovative next-generation product, named the ONE, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

ONE consists of a user-friendly headset equipped with 21 soft-tip electrodes positioned according to the commonly followed 10-20 EEG3 system, accompanied by intuitive LED feedback for easy adjustments. It 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, AI-enabled notifications for seizure activity4, crucial in critical or emergency scenarios5,6. ONE seamlessly streams data to the Zeto Cloud, enabling live remote interpretations by board-certified neurologists. 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.

Zeto’s Founder and CEO, Aswin Gunasekar stated, “Breakthrough changes arise from the cumulative effect of years of gradual improvements. 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.”