The EEG system features a 21-electrode setup and cloud connectivity to help clinics address staffing shortages and expand access to neurodiagnostics.
Key takeaways:
- Zeto New Wave received FDA 510(k) clearance for short-term EEG recordings of up to 2.5 hours in outpatient clinics and homes.
- The system uses 21 soft-tip electrodes placed according to the 10-20 system and captures synchronized video, audio, and optional physiological signals.
- The device aims to reduce patient wait times and ease the burden on clinics facing shortages of specialized EEG technologists.
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Zeto Inc for Zeto New Wave, its newest electroencephalogram (EEG) system designed for outpatient clinics and homes.
Patients across the US often face weeks-long wait times for EEG appointments, delaying critical answers and care. Clinics simultaneously navigate shortages of specialized EEG technologists and rely on traditional setups that can be slow and cumbersome, further delaying testing and follow-up care. Zeto New Wave is designed to address these challenges by offering an easy-to-use outpatient routine EEG solution.
The system features full head coverage with 21 soft-tip, no-mess electrodes placed according to the widely used 10-20 system. It pairs with a recording device equipped with a built-in display and controls. The device captures synchronized video and audio alongside optional signals, such as electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), orientation sensors, external triggers for event-related potentials, and integrated photic stimulation detection.
Designed for short-term recordings of up to 2.5 hours, the system enables clinics to perform EEGs efficiently.
“New Wave is our newest outpatient EEG system, built on lessons learned from our first-generation device, the Zeto WR19,” says Florian Strelzyk, PhD, chief executive officer of Zeto, in a release. “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 clearance of Zeto New Wave marks the company’s third FDA-cleared device, joining the Zeto WR19 and Zeto ONE. Zeto also provides artificial intelligence-powered seizure detection, seizure burden analysis, and other quantitative analytics to support clinical decision-making.
