Zeto said it 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..
Zeto New Wave is designed to address the wait times U.S. patients often face. It offers a complete outpatient routine EEG solution, featuring a full head coverage with 21 soft-tip, no mess electrodes placed according to the widely used 10–20 system. Paired with a compact recording device with built-in display and controls, the system also captures synchronized video and audio, along with optional signals such as ECG, EOG, EMG, orientation sensors, external triggers for event related potentials (ERPs), and integrated photic stimulation detection.
Designed for short-term recordings of up to 2.5 hours, Zeto New Wave enables clinics to perform EEG efficiently and provide timely care to patients.
“New Wave is our newest outpatient EEG system, built on lessons learned from our first-generation device, the Zeto WR19,” said Florian Strelzyk, PhD, 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.”
The FDA clearance of the Zeto New Wave marks Zeto’s third FDA-cleared device, alongside 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.
