Zeto EEG System (New Wave / ONE)

by Zeto Inc.  · Based in United States → — Rapid, Full-Montage EEG Headsets with Seizure Detection* Gel-free POC EEG systems with real-time remote monitoring.
Critical Care Neurology
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Regulatory Status Disclosed

Overview

Zeto Inc. offers innovative, FDA-approved, portable EEG headsets designed to streamline neurological diagnostics. Their system includes the Zeto ONE for critical care and the Zeto New Wave™ for outpatient EEGs, both featuring gel-free application and rapid setup. [1, 11, 14, 19, 20] The accompanying cloud platform provides live viewing, advanced analysis tools, and AI-enabled notifications, including NeuroPulseTM for seizure burden and status epilepticus detection. [19, 20] This comprehensive solution aims to improve patient access to timely EEG testing and enhance diagnostic efficiency for providers across various healthcare settings. [4, 19]

Zeto’s technology is trusted by over 200 top US healthcare facilities and has received numerous awards for innovation and quality. [website content] The system is designed for ease of use, allowing medical assistants and other staff to apply the headsets quickly and efficiently, improving patient care, especially for those who travel long distances. [14, 19] The cloud platform is HIPAA-compliant and cybersecurity-cleared, offering seamless data storage, remote access, and integration with third-party platforms. [1, 10, 11, 19, 25, 27]

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • FDA-cleared portable EEG headsets (Zeto ONE, New Waveu2122)
  • Gel-free, dry electrodes with no skin prep or cleanup
  • Rapid, full 10-20 montage EEG setup (under 5 minutes)
  • Cloud platform with live viewing and real-time remote monitoring
  • AI-powered seizure burden and status epilepticus detection (NeuroPulseTM)
  • Advanced analysis tools and comprehensive report generator
  • High-resolution video and audio recording capabilities
  • Data export in EDF+, .txt, .xlsx, .docx, PDF, .csv, .zmrk formats
  • API options for real-time data streaming (LSL) and cloud-based data access
  • Active Electrode Technology (AET) and Dynamic Noise Cancellation (DNC) for signal quality

Use Cases

  • Critical care monitoring (ICU, emergency departments, EMS vehicles)
  • Outpatient EEG diagnostics in clinics and private practices
  • Neurological research and clinical trials
  • Seizure and status epilepticus management
  • Optimizing emergency stroke transport strategies
  • Remote EEG monitoring and interpretation services

What Physicians Need to Know

Stroke Detection Speed
Zeto is actively involved in clinical trials evaluating EEG as a biomarker for detecting neurological deterioration in acute ischemic stroke patients and for pre-hospital detection of large vessel occlusion (LVO) strokes. Research indicates that dry electrode EEG has the potential to detect LVO-a stroke in the prehospital setting with high diagnostic accuracy (AUC 0.91 for Brain Symmetry Index in delta frequency band).
EEG Interpretation AI
The system features AI-powered seizure burden and status epilepticus detection through NeuroPulseu2122 and NeuroNotisu2122 AI report. NeuroNotisu2122 combines AI seizure detection with human technical review, providing results approximately 15 minutes after the first hour of recording. The AI algorithms are designed for early and highly sensitive detection of seizure burden and electrographic status epilepticus.
Seizure Detection
Zeto provides rapid, full-montage EEG headsets with AI-powered seizure detection. NeuroPulseu2122 is highlighted as the first FDA-cleared AI-powered status epilepticus software for full montage EEG. AI-enabled notifications offer near real-time alerts for abnormal brain activity indicative of a seizure, with reported sensitivity of 89% and specificity of 70% for spikes and sharp waves.
Neurodegenerative Disease Screening
Zeto is exploring the use of EEG to detect early markers for Alzheimer's disease and dementias, with ongoing research into EEG biomarkers for diagnosis and triage of different types of dementia.
Large Vessel Occlusion Detection
The Zeto system is being utilized in clinical trials focused on the pre-hospital detection of Large Vessel Occlusion (LVO) strokes using EEG-based biomarkers and machine learning. Studies suggest dry electrode EEG holds potential for detecting LVO-a stroke in prehospital settings.
Triage Prioritization Speed
Zeto's systems, including Zeto ONE and New Wave, are designed for rapid setup (under 5 minutes) and incorporate AI triage tools for critical and emergency care. This streamlines the process, aiming to reduce diagnostic delays and improve patient throughput. The NeuroNotisu2122 AI report, with human review, provides results approximately 15 minutes after the first hour of recording.
Mobile Notification System
The Zeto system provides AI-enabled, near real-time notifications for seizure activity, crucial for critical conditions or emergency events. The Zeto Cloud platform facilitates remote access and monitoring, enabling healthcare providers to stay informed from various locations.
Physician Tip

The Zeto EEG system offers rapid setup and AI-powered seizure detection, which is highly beneficial in emergency and critical care for timely intervention. Physicians can leverage the NeuroNotisu2122 AI Report for quick insights, combining AI analysis with human technical review. The cloud-based platform's remote monitoring and interpretation capabilities provide workflow flexibility and access to expert neurologists, particularly valuable in areas with limited specialists. Consider Zeto for expanding EEG access across various care settings, including ICU, ED, outpatient clinics, and pre-hospital environments, due to its portability and ease of use. The system's ability to integrate with other physiological signals (ECG, EOG, EMG) and external triggers can enhance comprehensive patient assessment and research applications.

Zeto integrates seamlessly with numerous third-party partners, supporting the import of EEG data using standard EDF+ file formats. It allows for real-time EEG data streaming at low latencies into non-Zeto applications for continuous processing or recording. For research, the platform offers multiple API options and ERP/TTL triggering, enabling interaction with EEG and synchronized video data using scripting languages like Pythonu00ae and MATLABu00ae. The Zeto Cloud platform is designed as an open infrastructure to facilitate the development of specialized applications for conditions such as stroke rehabilitation, autism, and Alzheimer's detection, and to integrate other EEG service provider applications. The system also captures synchronized video and audio, and can integrate optional physiological signals like ECG, EOG, EMG, orientation sensors, and external triggers.

Details

Category Neurology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact sales for details — Price range is based on features, service level agreement, and purchase terms. [14, 22]
DeploymentPortable headsets, cloud platform, web-based access (HTML5 browser)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Zeto EEG devices, including Zeto ONE (K233403) and New Wave™ (K260455), are FDA-cleared for clinical-grade data quality and diagnostic use, restricted by Federal (US) law to sale by or on the order of a physician. [1, 4, 16, 20, 22, 26]
Integrations
EHR Not specified
Specialties Critical Care, Neurology

What the Web Says

The Zeto EEG System, including its New Wave and ONE models, is generally well-received by physicians and healthcare professionals for its ease of use, efficiency, and ability to expand access to EEG testing. It's particularly praised for its quick setup, patient comfort, and cloud-based platform for remote interpretation. The system aims to address challenges like staffing shortages and long wait times for traditional EEG appointments.

Overall: Positive

Strengths

  • User-friendly and easy to apply, even for non-EEG technologists.
  • Significantly reduces setup and cleanup time compared to traditional EEG systems.
  • Patients find it more comfortable due to no-mess, soft-tip electrodes and lack of glue.
  • Expands access to EEG testing in underserved areas, smaller hospitals, and for home use.
  • Cloud-based platform allows for remote access and interpretation by neurologists.
  • Provides high-quality EEG data with full head coverage and integrated video/audio.

Limitations

  • Concerns about artifact recovery, with even minor movements causing prolonged artifact across all channels.
  • Some users express concern about the need to readjust electrodes to check impedance, especially for ambulatory EEGs.
  • AI aspects are not always seen as a replacement for direct interpretation by a neurologist.
  • Limited montage in some point-of-care EEG systems may not replace a full montage EEG for all indications.

Based on reviews from: Zeto EEG (Testimonials, Case Studies), NeurologyLive, Sleep Review, BioSpace, Reddit, PR Newswire, Medical Device Network, Fierce Biotech, PubMed

Last updated: 2026-08-09

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Support & Docs
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Press & Coverage

Medical Economics
Zeto receives FDA Clearance for outpatient EEG system
Zeto Inc. announced it received U.S. FDA 510(k) clearance for Zeto New Wave, its latest EEG system for outpatient clinics and home use, featuring 21 soft-tip electrodes and a compact recording device. This marks Zeto's third FDA-cleared device, complementing Zeto WR19 and the ICU/ED-focused Zeto ONE, all running on the Zeto Cloud platform for remote access.
2026-04
PR Newswire
Zeto Announces FDA 510(k) Clearance of Zeto New Waveu2122, Advancing Efficiency in Outpatient EEG
Zeto, Inc. received U.S. FDA 510(k) clearance for Zeto New Waveu2122, its newest EEG system designed to improve efficiency and access to EEG in outpatient clinics and homes. This system offers full head coverage with 21 soft-tip, no-mess electrodes and a compact recording device, addressing challenges like appointment delays and technologist shortages.
2026-04
Zeto Inc. News
Zeto Introduces NeuroNotisu2122: An AI-Enabled Report with Human Review
Zeto, Inc. launched NeuroNotisu2122, a new offering for hospital customers that combines AI-enabled seizure detection with review by Registered EEG Technologists to provide more confident clinical decisions. This service integrates seamlessly into existing workflows and is included in Zeto's service agreements, making it cost-neutral for hospitals.
2026-04
Zeto Inc. News
Zeto Announces 2026 Clinical Trial Sponsorship Winners Advancing EEG in Stroke, Delirium, and Epilepsy
Zeto, Inc. announced the recipients of its 2026 Clinical Trial Sponsorship Program, supporting innovative research that integrates EEG into real-world clinical environments for stroke, delirium, and epilepsy. This program aims to advance brain health insights and make EEG a foundational vital sign in healthcare.
2026-03
PR Newswire
Zeto, Inc., Secures $31 Million In Series B Funding To Redefine The Future Of EEG Brain Monitoring
Zeto, Inc. successfully closed a $31 million Series B funding round, led by MindWorks Global, to further its mission of revolutionizing EEG diagnostics with its cutting-edge devices and AI-driven cloud platform. The funding will support the company's efforts to redefine the future of EEG brain monitoring.
2025-01
Zeto Inc. News
Zeto obtains FDA 510(k) clearance for its groundbreaking next-generation EEG brain monitoring product, ONE.
Zeto, Inc. announced that its innovative next-generation product, Zeto ONE, received 510(k) clearance from the U.S. FDA for EEG brain monitoring in various environments, including hospitals, homes, ambulances, and air transport. This clearance addresses the unmet needs in healthcare due to the shortage of trained EEG technologists.
2024-06
Zeto Inc. News
Huntsville Memorial Hospital Reduces Patient Transfers and Enhances Local Care with Onsite EEG Program Powered by Zeto
Huntsville Memorial Hospital successfully implemented a new onsite EEG program powered by Zeto, Inc., which has significantly reduced emergency room patient transfers and improved access to neurological care locally. This initiative highlights the effectiveness of Zeto's rapid-setup, gel-free EEG solution in real-world clinical applications.
2025-06

Videos

Product demos, reviews, and walkthroughs for Zeto EEG System (New Wave / ONE).

View all on YouTube

Frequently Asked Questions

The Zeto EEG System's AI provides automated seizure detection, seizure burden analysis, and other quantitative analytics, designed to offer preliminary analysis and highlight areas requiring expert review. This can streamline the review process and potentially accelerate diagnosis and treatment decisions by providing real-time notifications of seizure activity.
Yes, Zeto's EEG systems, including their AI-powered seizure detection features, are FDA cleared for clinical use. The Zeto Cloud platform is designed to be HIPAA-compliant, utilizing secure data encryption and access controls to protect patient information, and also meets FDA 21CFR820 cybersecurity requirements.
While the Zeto AI can detect patterns and flag events like seizures, it is intended to augment, not replace, the physician's diagnostic capabilities. The system does not provide definitive diagnostic conclusions or alarms about a patient's condition, requiring a trained neurologist for final interpretation and clinical decision-making.
The Zeto system utilizes dry electrodes, eliminating the need for gel and extensive skin preparation, which significantly reduces setup time to minutes and enhances patient comfort compared to traditional wet-electrode systems. It offers full 10-20 montage coverage and has demonstrated signal quality non-inferior to conventional EEG systems in validation studies.
The pricing model generally includes an upfront cost for the hardware, followed by a subscription fee for software access, cloud storage, and ongoing AI feature updates. Specific pricing details are customized based on features and service level agreements, and Zeto ONE's EEG System receives the same reimbursements as a traditional EEG.
The Zeto EEG System is designed for ease of use with a cloud-based platform for data management and reporting. While it doesn't currently offer a direct HL7 interface, finished reports can be imported into EHRs as PDF or .docx documents or via clipboard pasting, and it can tie into EHRs for patient scheduling.
Zeto has conducted and published validation studies demonstrating the accuracy and reliability of its AI algorithms for event detection, such as seizure activity and seizure burden analysis. These studies indicate that the signal quality is non-inferior to conventional clinical EEG systems and that the AI provides high sensitivity for seizure detection.

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Suggest an Edit → | Last Verified: 2026-05-06 | First Added: 2026-05-06

Investors who backed Zeto EEG System (New Wave / ONE)

Funded through the company that built this tool.

Tsingyuan Ventures
VC T3
Los Altos, United States
$250k-$1M
Tsingyuan Ventures, accessible via foothill.ventures/tsingyuan, is the Tsinghua alumni-aligned arm of the Foothill Ventures platform, historically focused on early-stage US-China bridge investments…
AI/ML in Healthcare Biotech
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