Zeto Secures FDA Clearance for New Wave EEG System

Zeto has received 510(k) clearance from the US Food and Drug Administration for its New Wave electroencephalogram (EEG) system, marking its third FDA-cleared device.

Designed for outpatient clinics and home care settings, the New Wave system enables faster, more accessible neurological testing. It features 21 soft-tip electrodes arranged using the standard 10–20 system, along with a compact recording unit that includes built-in controls and synchronized video and audio capture.

The device also supports additional monitoring options such as ECG, EOG, and EMG, along with advanced features like orientation sensors and photic stimulation detection. It allows EEG recordings of up to 2.5 hours, helping clinicians deliver timely diagnostics.

The system is designed to expand access, improve efficiency, and enhance patient experience across care settings.

06-04-2026