FDA Clears Zeto New Wave Outpatient EEG System

Zeto, a company that aims to make brain health insights through EEG a foundational vital sign in healthcare, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Zeto New Wave, its newest EEG system for outpatient clinics and homes.

U.S. patients often wait weeks for an EEG appointment, which delays critical answers and care. Clinics also face shortages of EEG technologists and rely on traditional setups that can be slow and cumbersome.

Zeto New Wave was engineered to change that—it represents a complete outpatient routine EEG solution. It features a full head coverage with 21 soft-tip, no mess electrodes place according to the widely used 10-20 system. It’s paired with a compact recording device with built-in display and controls and captures synchronized audio and video—along with optional signals such as ECG, EOG, EMG, orientation sensors, external triggers for event related potentials (ERPs), and integrated photic stimulation detection.

Zeto New Wave was designed for short-term recordings of up to two and a half hours. It allows clinics to perform EEG efficiently and offer timely care, the company said.

“New Wave is our newest outpatient EEG system, built on lessons learned from our first-generation device, the Zeto WR19,” said Florian Strelzyk, Ph.D., CEO of Zeto. “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 New Wave marks the company’s third FDA-cleared device, along with Zeto WR19 and Zeto ONE. Zeto offers EEG solutions for critical and emergency care, academic research, clinical trials, and outpatient clinics, and also provides AI-powered seizure detection, seizure burden analysis, and other quantitative analytics.