Zeto Receives FDA Clearance for New Wave EEG System to Address Outpatient Neurodiagnostic Delays
Key Insights
Zeto (search) has received FDA 510(k) clearance for its New Wave electroencephalogram system, marking the company's third FDA-cleared device designed for outpatient clinics and home-based care.
The system features 21 soft-tip electrodes with full head coverage and supports short-term EEG recordings up to 2.5 hours, addressing weeks-long patient wait times for EEG appointments.
New Wave aims to help clinics expand access to neurodiagnostics while addressing critical shortages of specialized EEG technologists through its user-friendly design and cloud connectivity.
Zeto (search) has received US Food and Drug Administration (FDA) 510(k) clearance for its New Wave electroencephalogram (EEG) system, addressing critical delays in neurodiagnostic testing that leave patients waiting weeks for appointments. The clearance marks the company's third FDA-approved device and represents a significant step toward expanding access to EEG testing in outpatient settings.
Addressing Critical Healthcare Gaps
Patients across the United States currently face weeks-long wait times for EEG appointments, delaying critical diagnostic answers and care. Healthcare facilities simultaneously navigate shortages of specialized EEG technologists while relying on traditional setups that can be slow and cumbersome, further extending testing delays and follow-up care timelines.
The New Wave system is specifically designed to tackle these challenges by providing an easy-to-use outpatient routine EEG solution that can be deployed in both clinical and home-based settings.
Technical Specifications and Features
The New Wave system features comprehensive neurodiagnostic capabilities with 21 soft-tip, no-mess electrodes placed according to the widely used 10-20 system for full head coverage. The device pairs with a compact recording unit equipped with a built-in display and controls, capturing synchronized video and audio alongside the EEG data.
Additional physiological monitoring capabilities include optional electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), integrated orientation sensors, external trigger inputs for event-related potentials, and photic stimulation detection. The system supports short-term EEG recordings of up to 2.5 hours, enabling clinics to perform efficient diagnostic testing.
Strategic Product Development
"New Wave is our newest outpatient EEG system, built on lessons learned from our first-generation device, the Zeto (search) 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."
The development follows Zeto (search)'s 2024 release of the ONE system, specifically designed for intensive care units, emergency departments, and patient transport. Both the New Wave and ONE systems operate on Zeto's Cloud platform, enabling remote access from any location and allowing healthcare providers to select the most appropriate system based on their specific needs and budget constraints.
Expanding Neurodiagnostic Portfolio
The New Wave clearance joins Zeto (search)'s existing FDA-cleared devices, including the Zeto WR19 and Zeto ONE, creating a comprehensive portfolio of EEG solutions for critical care, clinical trials, academic research, and outpatient applications. The company also provides artificial intelligence-powered seizure (search) detection, seizure burden analysis, and other quantitative analytics to support clinical decision-making.
Zeto (search)'s FDA-cleared EEG platforms are currently available commercially throughout the United States. In September 2024, the company expanded its market reach through a partnership with Firefly Neuroscience (search) to distribute its FDA-cleared EEG headsets.