Medical technology company Zeto, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Zeto New Wave™ system. This new device is designed to expand access to electroencephalogram (EEG) testing in outpatient clinics and home settings. The clearance marks Zeto's third FDA-approved product, reinforcing its mission to make brain health insights a foundational part of healthcare.
Confronting Delays in Neurological Care
Across the United States, patients frequently endure long waits for EEG appointments, which can significantly postpone crucial diagnoses and care. This delay in testing creates uncertainty for patients and can impede the timely management of neurological conditions. The bottleneck in scheduling ultimately affects the entire care pathway, from initial assessment to treatment planning and follow-up.
At the same time, clinical practices are contending with a persistent shortage of specialized EEG technologists. They often rely on traditional EEG setups that are cumbersome and slow, further compounding scheduling challenges. These operational pressures make it difficult for clinics to meet patient demand and provide efficient neurological diagnostic services.
A Modern Solution for Outpatient Clinics
The Zeto New Wave™ system is engineered to directly address these outpatient challenges with a complete, easy-to-use solution. It features a headset with 21 soft-tip electrodes that eliminates the need for messy conductive gels. The electrodes are placed according to the widely used 10–20 system, ensuring full head coverage and high-quality data collection.
Paired with the headset is a compact recording device that includes a built-in display and intuitive controls for seamless operation. The system captures synchronized video and audio, providing essential context for clinical interpretation of brain activity. It is specifically designed for short-term recordings of up to 2.5 hours, ideal for the outpatient workflow.
To support more advanced diagnostics, the New Wave™ system offers a range of optional signals. These include electrocardiogram (ECG), electrooculography (EOG), and electromyography (EMG) to monitor related physiological activity. It also integrates orientation sensors and photic stimulation detection, expanding its utility for diverse clinical and research applications.
Expanding a Comprehensive Neurodiagnostic Portfolio
This latest clearance strategically expands Zeto's product line, which now serves distinct healthcare environments. In 2024, the company released its Zeto ONE™ system, the first wireless, dry-electrode EEG device cleared for hospital use in ICUs and emergency departments. With New Wave™, Zeto now offers a custom-tailored solution specifically for the needs of physician practices and outpatient clinics.
Florian Strelzyk, PhD, CEO of Zeto, stated that New Wave™ was built on lessons learned from the company's first-generation device. "We listened to neurologists' needs and designed a system that helps clinics expand access to EEG, address staffing challenges, and improve patient experience," he noted. Both the New Wave™ and ONE™ systems run on the Zeto Cloud platform, enabling remote access from anywhere.
The FDA clearance of Zeto New Wave™ significantly strengthens the company's position as a leader in next-generation neurotechnology. By delivering accessible and actionable neurodiagnostic insights, Zeto is empowering clinicians to improve routine EEG monitoring and patient outcomes. This innovation moves the company closer to its goal of making brain health assessment as ubiquitous as any other vital sign.