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Home » Zeto picks up FDA clearance for outpatient EEG tech

Zeto picks up FDA clearance for outpatient EEG tech

April 3, 2026 By Sean Whooley

Zeto New Wave outpatient EEG system
The New Wave outpatient EEG system. [Image courtesy of Zeto]
Zeto announced that it received FDA 510(k) clearance for the New Wave electroencephalogram (EEG) system.

New Wave marks the Raleigh, North Carolina-based company’s latest EEG system for outpatient clinics and homes. Zeto says it addresses the long waits for EEG appointments and shortages of EEG technologists in hospitals. These issues can delay both vital testing and related follow-up care.

According to Zeto, it designed New Wave to change these issues through a complete, easy-to-use outpatient routine solution. It features full-head coverage with 21 soft-tip, no-mess electrodes placed according to the widely used 10-20 system.

New Wave pairs with a compact recording device that features a built-in display and controls. With this, it captures synchronized video and audio, along with optional signals like ECG, EOG, EMG, orientation sensors, external triggers for event-related potentials (ERPs) and integrated photic stimulation detection.

Zeto designed New Wave for short-term recordings of up to 2.5 hours. It enables clinics to perform EEG efficiently and provide timely care to patients.

FDA clearance makes New Wave Zeto’s third FDA-cleared device, alongside WR19 and Zeto ONE. It comes just over a year after Zeto raised $31 million to support its commercial operations and drive growth.

Florian Strelzyk, CEO, 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.”

Filed Under: 510(k), Food & Drug Administration (FDA), Health Technology, Neurological, Patient Monitoring, Regulatory/Compliance Tagged With: FDA, Zeto

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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