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Zeto obtains FDA 510(k) clearance for its groundbreaking next-generation EEG brain monitoring product, ONE.

Zeto ONE is approved for EEG Brain Monitoring across hospital, home, ambulance, and air transport environments.

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).

The intuitive LED feedback facilitates easy adjustments of the electrodes. The portable recording device captures video and audio of the patient while providing step-by-step guidance to the user.
The intuitive LED feedback facilitates easy adjustments of the electrodes. The portable recording device captures video and audio of the patient while providing step-by-step guidance to the user.
Electroencephalography (EEG) needs in health care remain significantly unmet due to permanent shortage of trained EEG technologists. New EEG products need to be easy to use for any staff, comfortable to the patient and provide excellent signal quality. However, hospitals also require comprehensive full-montage1,2 EEG for thorough coverage of clinically significant events, video capabilities to aid physicians in interpretation, and dependable diagnostic software for neurological emergencies. Without these elements, genuine progress in neurological care will remain unrealized.

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