Zeto has secured FDA 510(k) clearance for its New Wave electroencephalogram (EEG) system, a next-generation device designed to improve efficiency and access in outpatient and at-home brain monitoring.
The clearance marks the company’s third FDA-approved platform, expanding its growing portfolio of neurodiagnostic technologies that includes Zeto WR19 and Zeto ONE.
In addition to EEG solutions spanning critical and emergency care, academic research, clinical trials and outpatient clinics, the company also provides AI-powered seizure detection, seizure burden analysis and other quantitative analytics.
The Zeto New Wave system is built for short-term EEG recordings of up to 2.5 hours and is tailored for outpatient clinics and home use, addressing persistent bottlenecks in neurological care such as long wait times and shortages of trained EEG technologists.
By simplifying setup and workflow, the system aims to help clinicians deliver faster diagnoses and improve patient access to care.
At the core of the system is a full-head EEG headset equipped with 21 soft-tip, gel-free electrodes arranged according to the standard 10-20 system. This design eliminates the need for traditional, time-intensive electrode application, enabling more rapid deployment in clinical settings.
The device is paired with a compact recording unit featuring a built-in display and controls, allowing clinicians to conduct studies with minimal equipment and training.
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Beyond standard EEG acquisition, New Wave supports multimodal data capture, including synchronized video and audio, as well as optional physiological signals such as electrocardiogram (ECG), electrooculogram (EOG) and electromyogram (EMG). These capabilities provide a more comprehensive view of neurological activity, supporting diagnosis across a range of conditions.
The system also integrates with the company’s cloud-based platform, enabling remote data access and analysis. Zeto’s broader platform includes AI-powered tools for seizure detection and quantitative EEG analysis, further supporting clinical decision-making.
According to the company, New Wave was designed in response to clinician feedback, with a focus on improving patient experience while helping practices scale EEG services despite staffing constraints.
Beyond standard EEG acquisition, New Wave supports multimodal data capture, including synchronized video and audio, as well as optional physiological signals such as electrocardiogram (ECG), electrooculogram (EOG) and electromyogram (EMG). These capabilities provide a more comprehensive view of neurological activity, supporting diagnosis across a range of conditions.
The system also integrates with the company’s cloud-based platform, enabling remote data access and analysis. Zeto’s broader platform includes AI-powered tools for seizure detection and quantitative EEG analysis, further supporting clinical decision-making.
According to the company, New Wave was designed in response to clinician feedback, with a focus on improving patient experience while helping practices scale EEG services despite staffing constraints.
The device complements Zeto’s existing systems, including the WR19 for research and the ONE platform for intensive care and emergency settings.
“New Wave is our newest outpatient EEG system, built on lessons learned from our first-generation device, the Zeto WR19,” said Zeto CEO Florian Strelzyk, PhD. “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.”
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