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

This outpatient EEG system is intended for outpatient clinics and home-based care providers.

The clearance enables faster and more convenient patient testing, supporting the need for timely neurodiagnostic insights.

Zeto New Wave is designed as a comprehensive, user-friendly routine EEG solution.

The system features 21 soft-tip electrodes that are placed according to the 10–20 system for full head coverage. It includes a compact recording device with built-in display and controls and provides synchronised video and audio capture.

Additional features include optional ECG, electrooculogram (EOG), electromyogram (EMG), integrated orientation sensors, external trigger inputs for event-related potentials, and photic stimulation detection.

The device supports short-term EEG recordings up to 2.5 hours and allows clinics to deliver timely care.

Zeto CEO Florian Strelzyk said: “New Wave is our newest outpatient EEG system, built on lessons learned from our first-generation device, the Zeto WR19. We listened to neurologists' needs and designed a system that helps clinics expand access to EEG, address staffing challenges, and improve patient experience.

“In 2024, we released the ONE specifically for ICUs, EDs and for patient transport, and now with New Wave we custom-tailored an ideal solution for physician practices. Both systems run on our Zeto Cloud platform and enable remote access from anywhere. Now, providers can choose which system is best for their needs and budget.”

Zeto offers EEG solutions for critical care, clinical trials, academic research, and outpatient use, with AI support for seizure detection and quantitative analytics. The company’s FDA-cleared EEG platforms are available commercially in the US.

In September 2024, Zeto teamed up with Firefly Neuroscience to distribute its US FDA-cleared EEG headsets.