Zeto gains FDA nod for new outpatient EEG system promising faster brain health testing
By: IPP Bureau
Last updated : April 10, 2026 6:45 am
The FDA clearance of Zeto New Wave marks the company’s third cleared device, alongside Zeto WR19 and Zeto ONE
Zeto, a medical technology company focused on making brain health insights a standard vital sign, has announced it has received US FDA nod for Zeto New Wave, its latest EEG system designed for outpatient clinics and homes.
Across the US patients often wait weeks for an EEG appointment, delaying critical diagnoses and care. Clinics face mounting pressure from a shortage of specialized EEG technologists and traditional, cumbersome equipment—factors that can slow testing and follow-up care.
Zeto New Wave aims to change that. The system offers a complete, easy-to-use outpatient EEG solution with 21 soft-tip, no-mess electrodes covering the full head, placed according to the widely used 10–20 system.
Its compact recording device includes a built-in display and controls, capturing synchronized video and audio, along with optional ECG, EOG, EMG, orientation sensors, external event triggers, and integrated photic stimulation detection. Short-term recordings of up to 2.5 hours allow clinics to perform EEGs efficiently and provide timely patient care.
"New Wave™ is our newest outpatient EEG system, built on lessons learned from our first-generation device, the Zeto WR19," said Florian Strelzyk, 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 Zeto New Wave marks the company’s third cleared device, alongside Zeto WR19 and Zeto ONE. Zeto provides EEG solutions for critical and emergency care, academic research, clinical trials, and outpatient clinics, complemented by AI-powered seizure detection, seizure burden analysis, and other advanced analytics.