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FDA Clearance vs. FDA Approval: What’s the Difference in Medical Devices?

People often assume that all FDA-reviewed devices go through the same process. In reality, the U.S. Food and Drug Administration (FDA) uses multiple regulatory pathways, and the terms like FDA cleared, FDA approved, and FDA granted have specific meanings.

Understanding this distinction is important for healthcare professionals and patients, particularly in fast-moving fields such as neurology, digital health, and AI-enabled innovation.

Overview: Key Regulatory Pathways

At a high level, FDA clearance applies to most low-to-moderate-risk medical devices, while FDA approval applies to high-risk medical devices. A third pathway is De Novo, where the FDA “grants” a new device type for certain novel low-to-moderate risk devices with no predicate. These pathways differ significantly in risk classification, evidence requirements, review timelines, and cost. As a quick takeaway:

FDA Cleared (510(k)): FDA determined the device is substantially equivalent to a legally marketed “predicate” device for its intended use.
FDA Granted (De Novo): FDA classified a novel low-to-moderate risk device type when there is no suitable predicate.
FDA Approved (PMA): FDA reviewed evidence intended to demonstrate a reasonable assurance of safety and effectiveness for many high-risk (Class III) devices.
Exempt: Most low-risk (Class I) and some Class II devices do not require premarket review and can go directly to market, though they are subject to other controls.

People often say “FDA approved” as shorthand, but for many medical devices the more precise terms are cleared (510(k)) or granted (De Novo).

What Is FDA Approval?

FDA approval refers to the Premarket Approval (PMA) process, which is the FDA’s scientific and regulatory review to evaluate whether there is a reasonable assurance of safety and effectiveness for most Class III (highest-risk) devices.

This process requires manufacturers to provide independent scientific evidence, usually from extensive clinical trials, demonstrating a reasonable assurance that the device is safe and effective for its intended use.

The FDA provides an official overview of the PMA process on its website:
https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma

Key Characteristics of FDA Approval

FDA approval:

Applies to life-sustaining or life-supporting devices
Requires extensive clinical trials
Involves a detailed review of safety and effectiveness
Has longer timelines and significantly higher costs
Often includes post-market study requirements

Examples of FDA-Approved Devices

Implantable deep brain stimulation (DBS) systems
Implantable neurostimulators used for epilepsy management and other neurological conditions
Implantable continuous brain monitoring devices, such as long-term intracranial EEG systems used to detect and track seizure activity

These devices are typically implantable, life-sustaining, or life-altering, which places them in the FDA’s Class III (high-risk) category, requiring full FDA approval rather than clearance.

Example: A new implantable deep brain stimulation device for Parkinson’s disease must complete multi-year clinical trials and receive FDA approval via the PMA pathway before being marketed.

What Is FDA Clearance?

FDA clearance means a medical device has been reviewed through the 510(k) premarket notification process and found by the FDA to be substantially equivalent to an already legally marketed device. Such comparator devices are called predicate devices.

The FDA does not independently determine safety and effectiveness from scratch. Instead, it evaluates whether the new device is at least as safe and effective as an existing device already on the market.

The FDA provides an official overview of the 510(k) process on its website: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k

Key Characteristics of FDA Clearance

FDA clearance:

Applies primarily to Class II (moderate-risk) devices
Requires comparison to a predicate device
Typically relies on bench testing, software validation, and performance data
Clinical trials are often not required
Is faster and less expensive than FDA approval

Examples of FDA-Cleared Devices

Common FDA-cleared devices in the EEG and brain-monitoring industry include:

Non-implantable EEG acquisition systems used in clinical, ambulatory, and point-of-care settings
EEG analysis and visualization software, including cloud-based and AI-assisted interpretation tools
EMG and evoked potential (EP) systems used for neurological diagnostics
Neurophysiological patient monitoring systems for seizure detection and brain-state monitoring
Wearable and portable brain-monitoring devices designed for remote, home, or outpatient use

These devices are typically classified as moderate-risk (Class II) and are cleared through the 510(k) pathway by demonstrating substantial equivalence to existing EEG and neurodiagnostic technologies already on the market.

Example:
A company develops a new EEG monitoring system that uses established signal-acquisition technology and has the same clinical indications as an existing EEG device. If it can demonstrate substantial equivalence to the existing device, it may receive FDA clearance through the 510(k) pathway.

What Is FDA “Granted” (De Novo)?

If there is no appropriate predicate device, a company may pursue the De Novo pathway for certain novel low-to-moderate risk devices. If granted, the FDA establishes a new device type, classifies it as Class I or Class II, and establishes any special controls required for Class II devices. Future devices of the same type can then use the 510(k) pathway.

Key Differences at a Glance

Aspect	FDA Clearance	FDA Granted	FDA Approval
Regulatory Pathway	510(k) Premarket Notification	De Novo	PMA
Risk Level	Moderate (Class II)	Low to Moderate (Class I & II)	High (Class III)
Predicate Device	Required	No	No
Clinical Trials	Often not required	Often Required	Required
Review Time	Months	Months	Years

Common Misconceptions

“FDA cleared” does not mean “FDA approved.” These terms are not interchangeable, but both indicate the medical device can be legally marketed in the United States. Whether FDA cleared or approved, these devices’ manufacturers remain subject to quality system regulations, labeling requirements, post-market surveillance, and adverse event reporting.

An “FDA approved” label doesn’t inherently mean a device is better than an “FDA cleared” one. Those terms reflect FDA-defined regulatory pathways that are determined by a device’s risk classification, how well it fits within existing device types, and whether there’s an appropriate predicate, not a manufacturer’s preference for one label over another.

For many moderate-risk devices, the 510(k) pathway is available when a manufacturer can demonstrate the new device is substantially equivalent to a legally marketed predicate. In this pathway, the demonstration of substantial equivalence serves as a proxy for a direct demonstration of reasonable assurance of safety and effectiveness.

For example, an EEG system that can leverage a well-established, “gold standard” predicate may reach the market via 510(k) by demonstrating substantial equivalence to that predicate’s performance and intended use.

For PMA devices, showing similarity to a predicate is not considered sufficient evidence because the PMA standard is affirmative: the manufacturer must provide valid scientific evidence demonstrating a reasonable assurance that the device is safe and effective for its own specific intended use.

In higher-risk contexts, the FDA generally does not rely on substantial equivalence as a proxy for safety and effectiveness. Small differences in design, materials, software, human factors, or clinical workflow can meaningfully change the risk profile and clinical performance, and the consequences of unexpected failure are higher. As a result, the FDA typically requires direct evidence (bench, animal when relevant, and often clinical data) that addresses the device’s specific risks and demonstrates that the benefits outweigh those risks for the intended population and use.

Bottom line: ‘cleared’ versus ‘approved’ is about which regulatory route applies given FDA definitions and risk-based requirements. It is important to note that the fundamental legal standard for all pathways is to provide a reasonable assurance of safety and effectiveness; the pathway simply defines the method used to demonstrate it. The meaningful comparisons between devices come from their indications for use, claims, and supporting evidence, not from the cleared/approved label alone.

Final Thoughts

FDA clearance and FDA approval serve different but equally important roles in ensuring medical device safety in the United States. Clearance focuses on equivalence and performance for moderate-risk devices, while approval requires direct proof of safety and effectiveness for high-risk technologies.

For many innovations in neurology and digital health-especially those based on EEG technology-FDA clearance through the 510(k) pathway is the appropriate and established regulatory process, not a shortcut.

Disclaimer: This article is for informational purposes only and does not constitute legal or regulatory advice. The information provided is a general overview of FDA regulatory pathways and should not be relied upon as a substitute for consulting with a qualified regulatory professional. The FDA’s regulations and guidance are subject to change.

Rapid Response RN Podcast Episode: How Point-of-Care EEG Is Transforming Rural ICU Care

How one ICU nurse leader brought rapid EEG to her community hospital – and why it’s keeping more patients near home.

This is a transcription from the Rapid Response RN podcast episode featuring Kristen Marin, RN, Director of Critical Care and Trauma Services at a community hospital in Northern California. The episode explores how rural ICUs can expand care capabilities and keep patients close to home.

Podcast Episode: Rapid Response RN – Caring Close to Home
🎧 Listen to the full episode: LINK

Watch video: https://youtube.com/shorts/dvghkhVADAo

For rural families, a hospital transfer isn’t just a change in care level – it can mean separation, long drives, financial hardship, and missed time with loved ones during critical moments. These are the challenges Kristen Marin has spent nearly 20 years addressing.

A Rural Nurse with a Mission

Kristen has spent her career at the same community hospital, working in Med-Surg, Emergency and Trauma, and now ICU leadership. Her focus has always been on rural healthcare.
“I’m a self-proclaimed rural nursing champion,” she says. “I’m drawn to caring for the people in my community.”
Her goal has been to expand services that reduce unnecessary transfers – one of the biggest challenges in rural care.

The Reality of Rural Critical Care

In rural settings, transfers are often dictated not just by patient needs but by limited local resources, distance, and weather. The nearest tertiary center may be hours away, EMS availability can be unpredictable, and receiving hospitals are often full.

Before introducing EEG services, the hospital routinely transferred patients with:

unexplained altered mental status
suspected or possible seizures
unclear neurological symptoms

Not because they necessarily required a higher level of care, but because clinicians had no way to confirm what was happening.

Expanding ICU Capabilities

When the team explored diagnostic tools to expand their ICU capabilities, point-of-care EEG emerged as a practical solution. Because rural hospitals rarely have neurodiagnostic technologists, Kristen’s team developed a new workflow:

Provider orders spot EEG
Trained RN or RT places the headset
Device captures a 30–60 minute recording
Data is sent to remote neurologists
Team receives rapid interpretation and care guidance

“It’s empowering,” Kristen says. “Our staff saw it as professional development. Who knew you could work in a rural hospital and be doing EEGs?”

This approach allowed the hospital to make informed decisions about which patients truly require transfer.

The Result: Fewer Transfers, Faster Answers, Stronger Community Care

“We are keeping these patients local,” Kristen emphasizes.

With rapid EEG, the team can quickly determine whether a patient is seizing, experiencing metabolic encephalopathy, or presenting with non-epileptic symptoms. Families stay involved, patients stay near home, and clinicians make decisions based on data rather than uncertainty.

“I see families at the bedside while we’re doing the EEG, and I can explain what we’re doing and why,” Kristen says. “It’s meaningful. I wish we’d done this sooner.”

Advice to Nurse Leaders: Be the Catalyst

Kristen encourages other rural nurse leaders to:

Align with your hospital’s mission to prioritize patient-centered care
Collaborate closely with physicians to ensure successful implementation
Select technology that supports and empowers staff
Advocate boldly to drive meaningful change

One Year Later: A More Capable Rural ICU

The hospital now receives requests from outpatient physicians for EEG services – an unexpected but welcome evolution.
“It’s been good for our patients, for our staff, for our hospital,” Kristen says. “I’m so happy we took the jump.”

Integrating Neurodiagnostics Into a Rural Hospital – American Heart Association’s Scientific Sessions

In this presentation from the American Heart Association’s Scientific Sessions, Joe Daniel Schorre, Director of Cardiopulmonary and Emergency Management at Huntsville Memorial Hospital in East Texas, shares how his team solved a major care gap: the complete absence of EEG services in their rural community.

With no neurologists on staff, no EEG techs, and no ability to perform EEG onsite, the hospital had been forced to transfer nearly half of its neuro-related patients – about 10 patients each month – solely because EEG was unavailable. Joe explains how implementing the Zeto rapid EEG system enabled faster diagnosis, reduced transfers, retained critical hospital revenue, and kept patients closer to home and family support.

For a deeper look at Huntsville Memorial Hospital’s journey, you can also read the full case study with Joe Schorre here: View detailed case study → LINK.

Below is the transcript of his talk.

Huntsville Memorial Hospital, a rural facility in East Texas about 60 miles north of major academic medical centers, was founded in 1927. It is a 123-bed acute care hospital serving a diverse population that includes families with limited incomes, a high local poverty rate, seven state prisons, and a large university community. The hospital’s mission is to care for the community with compassion, integrity, and excellence.

A 24-month review of emergency transfers revealed a clear problem: the hospital was sending out every patient who required EEG services. These transfers often meant more than an hour of travel, delayed diagnosis and treatment, lost hospital revenue, and significant financial and emotional burdens on families. The average out-of-pocket cost for a transfer was around $200, not including lost wages or the stress placed on patients and caregivers. For many in the community, this was simply unsustainable.

The team needed an EEG solution that fit into the existing workflow, required minimal capital investment, and didn’t rely on specialized EEG personnel. After evaluating available technologies, they selected the Zeto rapid EEG system, which integrates easily into the respiratory care workflow and allows remote epileptologists to review studies live when necessary and complete final interpretations afterward.

Within three months, the hospital moved from device selection to full implementation, going live on December 16, 2024. In the first six months, the program enabled the hospital to retain 44 admissions that otherwise would have been transferred. This kept patients close to home, preserved essential hospital revenue, and reduced the financial and emotional strain associated with transfers.

Keeping patients local improves continuity of care, supports faster diagnosis and treatment, and allows families to remain involved at the bedside. It also strengthens trust between Huntsville Memorial Hospital and the community it serves.

This program has been transformative for the facility and is something many rural hospitals may want to consider. It reduces unnecessary transfers, increases admissions that would otherwise be lost, and elevates the level of care delivered locally. Huntsville Memorial Hospital is proud to share the impact of this initiative and the role Zeto EEG has played in supporting rural healthcare.

Many small hospitals face similar challenges: no EEG services, no neurologists to interpret studies, and no EEG technicians. The hospital’s review showed that nearly half of its neuro-related transfers—about 10 patients per month—were due solely to the absence of EEG. Implementing rapid EEG directly addressed this gap and brought essential neurodiagnostic capabilities to the community.

Bring rapid EEG to your rural hospital

If your facility faces high transfer rates, limited access to neurologists, or challenges delivering neurodiagnostic services, Zeto can help you.

Learn more or schedule a demo → Contact Us

Expanding Global EEG Access: Zeto Research Program Supports Feasibility Study in Zambia

At Zeto, we’re committed to advancing EEG research and expanding access to brain monitoring technology worldwide. Through our annual Clinical Trial Sponsorship Program, we support researchers who are pushing the boundaries of neuroscience and patient care.

We’re proud to spotlight one of our 2025 winners: a groundbreaking feasibility study that could transform neurological care in sub-Saharan Africa.

Pilot Evaluation of Continuous EEG Implementation for Seizure and Status Epilepticus Management in Zambia (PRECISE-Z)

Led by Dr. Clio Rubinos and an international team of neurocritical care and epilepsy experts from the University of North Carolina (UNC) and University Teaching Hospital (UTH) in Lusaka, Zambia, this project seeks to evaluate the feasibility and acceptability of implementing continuous EEG (cEEG) using the Zeto One system in a low-resource healthcare setting.

Addressing a Critical Gap in Neurological Care

Over the past two decades, the use of continuous EEG (cEEG) monitoring has become an essential part of managing critically ill patients in high-income countries, particularly for detecting electrographic seizures (ESz) and electrographic status epilepticus (ESE). However, in low- and middle-income countries (LMICs), access to this life-saving technology remains extremely limited.

In Zambia, patients with altered mental status or coma rarely have access to cEEG, leading to undiagnosed seizures and potentially preventable neurological injury. The PRECISE-Z study aims to bridge this gap by introducing a rapid, full montage, wireless, and easy-to-use EEG solution that can be implemented without the infrastructure traditionally required for EEG monitoring.

Study Objectives

The trial has three key objectives:

Feasibility: Evaluate the use of the Zeto One system for continuous EEG (cEEG) monitoring to detect ESz and ESE in adult patients with altered mental status or coma in Zambia.
Acceptability: Assess perceptions of cEEG monitoring among patients, caregivers, nurses, and physicians in the Zambian clinical context.
Prediction Modeling: Develop a clinical prediction score to identify patients at highest risk for ESz and ESE, optimizing cEEG use where resources are limited.

Study Design and Methodology

The study will take place at University Teaching Hospital (UTH) in Lusaka — Zambia’s national referral center — where the neurology team has established EEG interpretation expertise.

The research team will recruit adult patients (≥18 years) with Glasgow Coma Scale ≤11 or FOUR score ≤12, who are being treated in either internal medicine wards or the ICU. Participants will undergo a 24-hour cEEG recording using the Zeto One device, with data interpreted by epileptologists in Zambia and the United States.

If seizures or status epilepticus are detected, the clinical care team will be notified for management per standard local protocols.

To assess feasibility, the team will document recording quality, artifact levels, and any operational challenges such as WiFi disruptions, power outages, or electrode displacement. Implementation feedback will also be gathered from the Zambian care teams and EEG technicians trained to use the system.

Acceptability will be evaluated through surveys and in-depth interviews with patients, caregivers, and healthcare providers, recognizing that epilepsy remains a highly stigmatized condition in Zambia and that patients are often cared for in open wards.

Building Local Capacity and Contextual Solutions

Beyond feasibility, the PRECISE-Z team will train neurology residents and EEG technicians on how to use the Zeto EEG system, fostering local expertise and long-term sustainability.

Importantly, the project aims to create a clinical prediction score tailored to Zambia’s patient population, helping clinicians identify those most likely to benefit from cEEG monitoring. This data-driven approach could guide future clinical decision-making in resource-limited settings.

Multidisciplinary Collaboration

The PRECISE-Z study is led by a collaborative team that brings together extensive experience in neurocritical care, EEG research, and global health:

Principal Investigator: Dr. Clio Rubinos, a neuro-intensivist and neurophysiologist from UNC with experience in ICU cEEG implementation in resource-limited environments.
Dr. Deanna Saylor, neurologist and clinical researcher at UTH and leader of Zambia’s neurology training program.
Dr. Melody Asukile, Zambia’s first epileptologist and a recipient of a Royal Society of Tropical Medicine and Hygiene grant.
Dr. Suzette LaRoche, epileptologist and advocate for improving neurodiagnostic access in underserved communities.

Ethical Oversight and Funding

The project will obtain ethical clearance from both the UNC Institutional Review Board and the University of Zambia Biomedical Research Ethics Committee. Informed consent will be obtained from participants or their legal representatives.

Funding for the cEEG recordings will be supported by the Zeto Research Program, with additional grant applications submitted to the Neurocritical Care Society Research Training Grant and INCLINE (Investing in CLINical Neurocritical CarE Research) Grant programs.

Anticipated Impact

The PRECISE-Z study is expected to demonstrate that rapid, wireless EEG can be feasibly and acceptably deployed in Zambia’s healthcare environment, despite infrastructure challenges such as limited ICU capacity, variable power supply, and the need for culturally sensitive implementation.

By developing local workflows, training healthcare professionals, and generating data to identify high-risk patients, the study represents a major step toward making continuous EEG accessible in resource-limited settings.

About the Zeto EEG Clinical Trial Sponsorship Program

Zeto EEG Clinical Trial Sponsorship program supports investigator-led projects that explore new frontiers in EEG access, usability, and clinical impact. Through partnerships with researchers and institutions around the world, Zeto aims to advance the understanding of brain health and make EEG monitoring more accessible to patients everywhere

More details: link

Zeto ONE Billing: Expanded CPT Codes for 24+ Hour EEG Monitoring

Full-Montage EEG with video capabilities

Understanding the appropriate CPT codes for EEG services is essential for accurate billing and reimbursement. With the introduction of Zeto ONE, our latest EEG headset for continuous monitoring, Zeto now has a product that can support both routine and longer-duration EEG studies. Following proper billing practices, Zeto now aligns with the expanded set of EEG CPT codes to support accurate documentation and billing.

In addition to our WR19 system for routine EEG collection, Zeto ONE enables extended monitoring up to 24+ hours with video, enabling clinicians to perform longer studies that may align with long-term EEG CPT codes.

Please note: The information provided in this article is for educational purposes only. This content is not intended as billing, coding, reimbursement or financial advice. Healthcare providers are advised to consult legal counsel and billing and coding specialists to determine appropriate CPT codes based on specific procedures, payer requirements, and patient needs.

Introducing Zeto ONE

Zeto ONE is our latest advancement in EEG monitoring, designed for long-term, continuous EEG monitoring in acute care settings. Zeto ONE is a user-friendly full-montage headset and a portable recording device that provides reliable bedside seizure detection*, accompanied by video, audio, and live remote monitoring and interpretation service.

* enabled by encevis

WR19 vs. Zeto ONE: Enhanced Capabilities

**Note:** The devices shown in this comparison image are for illustrative purposes only. In clinical practice, the Display Unit (DU) is mounted on bedside stands, not held by patients during monitoring.

	WR19	Zeto ONE
Monitoring Duration	Up to 6 hours	24+ hours
Primary Use Cases	Routine EEG	Triage, Routine, Stat, and Continuous EEG
Video Integration	Yes	Yes
Billing Codes Range	Routine EEG codes	Full spectrum including extended monitoring

Expanded CPT Code Coverage with Zeto ONE

For standard routine EEG billing codes (studies up to 2 hours), refer to our blog: Billing for Zeto: Zeto EEG Billing CPT Codes.

Long-Term Video EEG Monitoring (2-12 Hours)

Video	Monitoring	CPT Code Technical Component	CPT Code Professional Component
Without Video	Unmonitored	95705	95717
Without Video	Intermittent	95706	95717
Without Video	Continuous	95707	95717
With Video	Unmonitored	95711	95718
With Video	Intermittent	95712	95718
With Video	Continuous	95713	95718

Professional component codes include 95717 for studies without video and 95718 for studies with video. Zeto ONE’s advanced multi-stream video capability enables providers to utilize the video EEG codes when clinically appropriate.

Long-Term Video EEG Monitoring (12-26 Hours)

Video	Monitoring	CPT Code Technical Component	CPT Code Professional Component
Without Video	Unmonitored	95708	95719
Without Video	Intermittent	95709	95719
Without Video	Continuous	95710	95719
With Video	Unmonitored	95714	95720
With Video	Intermittent	95715	95720
With Video	Continuous	95716	95720

Technical Component for 24-Hour Monitoring

Technical component billing includes several options for extended monitoring:

95950 for seizure-focused monitoring for each 24-hour period, 95951 covers each additional 24-hour period.
95953 applies to computerized portable 16+ channel EEG monitoring for each 24-hour period
95956 covers portable EEG monitoring for each 24-hour period.

Video EEG: Enhanced Clinical Value and Reimbursement

Zeto ONE’s multi-stream video capability captures patient behavior, environmental factors, and seizure activity, enabling complete clinical assessment during long-duration EEG recordings. These integrated capabilities are designed to support robust documentation and assist clinicians in demonstrating medical necessity during the payer review process.

Key Documentation Requirements

Successful reimbursement for extended monitoring requires thorough documentation of medical necessity for monitoring durations exceeding routine timeframes. Clinical indications must clearly support the need for continuous versus intermittent monitoring EEG recordings. When billing video EEG codes, documentation should include specific rationale for video recording as well as the duration of the EEG based on clinical presentation and diagnostic requirements.

For 24+ hour studies, seizure detection protocols and safety monitoring procedures should be clearly documented to support medical necessity and appropriate code selection.

Conclusion

Healthcare providers can utilize Zeto ONE’s comprehensive monitoring range, from routine diagnostic studies to extended seizure monitoring with synchronized video capture.

For individualized guidance on EEG billing, several third-party consulting service providers are active in the market. For questions or an introduction to a consultant familiar with Zeto, complete the form below.

Disclaimer

Zeto, Inc. does not provide billing or coding services and does not offer advice, guidance, or recommendations regarding billing, coding, reimbursement, or claims submission. The information presented in this article is intended solely for general informational purposes and should not be construed as legal, compliance, coding, reimbursement, or financial advice.

It is the sole responsibility of each individual or organization to ensure the accurate selection and application of codes, modifiers, coverage, and documentation, as well as to establish medical necessity and submit claims in full compliance with all applicable federal, state, and local laws, regulations, and payor policies, including those of Medicare, Medicaid, and commercial insurers. To mitigate potential legal, financial, or regulatory risks, it is strongly recommended to consult with qualified legal counsel and experienced coding or reimbursement professionals. Requirements should also be independently verified with relevant payers and authoritative sources, prior to making any billing or coding decisions. This article is not a substitute for professional guidance or independent verification.

Zeto, Inc. makes no representations or warranties regarding the accuracy, completeness, or applicability of the information provided and expressly disclaims any liability for any losses, damages, or other consequences that may result from reliance on this content. Use of this information is at your own risk.

EEG in Supine Position: Making Bedside Monitoring Truly Bedside

Zeto ONE enables rapid, full-montage EEG while patients remain comfortably lying down – no gels, no electrode wires, no repositioning. ICU and ED teams now have a solution that matches the pace and complexity of real-world care.

Why Supine EEG Access Matters in Critical Care

In critical care and emergency environments, most patients are not sitting up. They’re post-surgical, unconscious, intubated, or in a medically complex state that makes repositioning impossible.

Being able to conduct high-quality EEG while lying down is more than a convenience. It’s a matter of life-saving speed.

Zeto ONE: Built for the Bedside

In most hospitals today, traditional EEG is still the standard of care – but that doesn’t mean it’s easy. These systems offer the full-montage data neurologists rely on, but they come with significant logistical hurdles. Setup takes 20–30 minutes, requires a trained EEG technologist, involves abrasive skin prep, messy gels, and a maze of wires. Especially for patients in critical conditions, with limited ability for re-positioning, preparing the scalp and gluing down traditional gel-based electrodes can take even longer than usual.

In response to these challenges, a new category of “rapid EEG” systems has emerged. But while these devices promise speed, they often sacrifice quality. Unlike some rapid EEG systems that are bulky or uncomfortable for patients lying down, the Zeto ONE is designed with a low-profile form that makes it easy for patients to rest comfortably on a pillow—no neck towel or special positioning required. The headset can be applied in under five minutes and removed just as quickly if a CT or MRI is needed. It’s gel-free and paste-free, so there’s no mess to clean up, and unlike many limited-channel systems, Zeto ONE delivers a full-montage 21-channel EEG, giving clinicians the diagnostic quality they need without compromising patient comfort.

Remote EEG Monitoring Without Compromise

Zeto ONE is more than just a rapid setup. It also supports real-time, cloud-based EEG streaming and integrates AI-powered seizure detection. Zeto comes closest to a traditional full montage EEG with all its benefits and seamless integration with the cloud.

Here’s what that means in the field:

Remote neurologists can begin interpreting EEG as soon as the recording starts.
The system provides automatic notifications for seizure activity and status epilepticus.

That means faster intervention. More accurate diagnosis. And fewer unnecessary patient transfers.

What Makes It Different From Traditional EEG?

Feature	Traditional EEG	Zeto ONE
Patient Comfort	Gel dries, wires interfere	Sleek design makes it comfortable.
Setup Time	15–25 minutes	~ 5 minutes
Specialized Technologist Required	Yes	No – any trained staff member
Gel / Paste Required	Yes	No
Patient Clean-up Required	Yes	No

Zeto ONE has been used to record over clinical 150,000 EEGs, many of them in high-stakes emergency and ICU environments. Providers using the system report faster workflows, better patient experiences, and a major reduction in unnecessary transports.

Ready to See It in Action?

Request a demo of Zeto ONE and learn how you can implement rapid, full-montage EEG at the bedside, in the ICU, or anywhere care happens.

EEG for Nurses: A Rapid Full EEG When Every Minute Counts

Zeto ONE makes it possible for nursing staff to initiate high-quality EEGs—no gel, no wires—when EEG technologists are unavailable.

In many hospitals, especially in emergency departments, intensive care units, and rural facilities, nurses are often the first clinicians to respond when a patient shows signs of a neurological emergency—such as nonconvulsive seizures, status epilepticus, or post–cardiac arrest encephalopathy. But traditional EEG systems are generally not deployed by nurses. They require EEG technicians – critical practitioners who unfortunately may not be always available in rural settings or off-hours.

Zeto ONE offer Rapid FULL Montage EEG for the ICU

It is the first FDA-cleared, full-montage EEG system that can be applied by trained nursing staff when EEG techs are unavailable—without requiring gels, glues, or specialized tools. The system is intuitive and wireless, enabling clinicians to initiate EEGs within minutes, even in critical care environments.

EEG technologists remain the gold standard in the administration of EEG studies. Zeto ONE offers EEG techs, and when they’re not available, other front-line staff such as nurses, an invaluable and easy to use tool when time to treatment is critical, and expert personnel are not immediately on-site.

Why Fast EEG Access Matters

EEG plays a vital role in diagnosing seizures—especially nonconvulsive seizures and nonconvulsive status epilepticus, which can be difficult to identify through clinical observation alone. In neurocritical care and emergency medical settings, delayed EEG access can delay treatment, particularly for patients in altered mental states following epileptic seizures or cardiac arrest.

Traditional EEG systems require:

Specialized EEG technologists for setup and monitoring
15–20 minutes or more for electrode placement
Gels, wires, and post-procedure cleanup

In the absence of an EEG tech, clinicians must either wait until they are available, which could be days, or transfer the patient— a time-intensive and resource-draining process.

With Zeto ONE, trained nurses can initiate EEGs in under five minutes, helping reduce diagnostic delays and supporting earlier intervention.

Zeto ONE: A Nurse-Friendly EEG System, Not a Replacement for Technologists

Zeto ONE is user-friendly enough to be deployed by neuro-ICU nurses, emergency teams, or critical care staff with minimal training. When EEG techs are unavailable, it enables immediate EEG acquisition that can be reviewed by physicians or EEG personnel remotely.

Key features include:

Full-montage high-quality EEG
Application in under 5 minutes—no gels, wires, or prep
Comfortable for supine patients in ICUs or emergency bays
Portable, compact headset fits seamlessly into crowded units
Quick to remove and reapply

Once applied, Zeto ONE begins recording immediately, sending data to a secure cloud-based platform that enables remote access for neurologists and EEG staff for interpretation.

Built-In Seizure Detection with NeuroPulse AI™

Zeto ONE includes NeuroPulse AI™, an AI-powered seizure detection tool trained on more than 21,000 hours of EEG recordings across over 800 patients. It continuously monitors for abnormal brain activity and automatically alerts care teams.

If seizure activity is detected:

Nurses receive a notification at the bedside
Physicians and EEG techs can be notified remotely

This capability empowers nursing staff to identify and respond to neurological deterioration, even in the absence of on-site specialists.

Streamlining Workflow for Nurses in Critical Care

Zeto ONE is designed to work within the constraints of busy, high-acuity units:

EEG studies are immediately available to remote neurologists
NeuroPulse AI™ generates real-time summaries and insights
No need to transport patients only to get EEG or coordinate external EEG services

It’s especially valuable during night shifts, weekends, or in smaller facilities without 24/7 neurology or EEG coverage.

Additionally, the system is:

Quick to remove and reapply for imaging procedures
Compact enough to store and charge within neurocritical care units
Non-disruptive to existing care protocols

Easy to Clean: A 5-Minute Protocol

Zeto ONE is also easy to maintain, with cleaning protocols that meet infection control standards without consuming staff time.

Our happy customer at Huntsville Memorial Hospital (HMH) in Texas, shared with us that their staff follow a 5-minute cleaning process that has passed routine inspections by their infection control nurse.

The process:

Step 1: Remove the headset—no gel, no residue, no skin irritation
Step 2: Wipe down the device using hospital-approved SaniWipes
Step 3: Use 70% isopropyl alcohol

“Cleaning takes about five minutes. We use hospital-approved wipes to reach all areas. Infection control inspected and approved the process.”
— Joe Schorre, Director of Cardiopulmonary and Emergency Management, HMH

Additional notes:

Cleaning is performed by respiratory techs or nurses immediately after use
Devices are stored in designated, upright positions for charging and longevity

The result is a workflow-friendly process that supports rapid turnover between patients.

Conclusion: A Critical Tool for Emergency Gaps

EEG techs are indispensable, and Zeto ONE is not a substitute for their expertise. But in moments when rapid neurological insight is needed—and a tech isn’t available—Zeto ONE gives nurses a fast, accessible solution.

By empowering nurses to apply EEGs in urgent moments, Zeto ONE helps prevent treatment delays, reduce unnecessary transfers, and improve outcomes in emergency and intensive care settings.

Want to see how Zeto ONE fits into your neurocritical care workflow?

Schedule a demo or explore our quick-start training resources.

EEG in Healthcare Transformed: Zeto Makes EEG Accessible Everywhere

While EEG in healthcare is the main use of the technology, EEG is no longer confined to hospital rooms. With Zeto’s cutting-edge technology, brain monitoring has become accessible in places you wouldn’t expect. From concert halls to ambulances, our portable, gel-free EEG systems empower researchers, clinicians, healthcare providers and caregivers to rethink where and how EEG can be used to improve lives.

At Zeto, we’re driving a new era of accessibility in EEG, transforming patient care and expanding its reach beyond traditional settings. In this blog, we explore real-world examples of how portable EEG is making an impact in diverse environments.

Join us in discovering how brain monitoring is becoming a seamless part of everyday life.

Bring EEG to ICUs and EDs

Our latest innovation, ONE, is making emergency EEG faster and easier, especially for hospitals that don’t have dedicated EEG resources. With full 10-20 electrode placement, video and audio recording, AI-powered triage tools, seizure activity monitoring, and remote reading services, ONE brings real-time brain monitoring right to the bedside.

Huntsville Memorial Hospital successfully implemented ONE for bedside brain monitoring, enabling nurses to apply the EEG headset in just about 5 minutes. The system provides real-time notifications for patients with suspected non-convulsive seizures, supporting faster and more informed clinical decisions around brain function.

Why It Matters:

In emergency settings, every second counts. Traditional EEG systems often require specialists and lengthy setups, delaying critical care. Zeto changes that.

Key Benefits

Eliminates the need for costly and time-consuming patient transfers to larger hospitals.
EEG setup can be performed by non-EEG technicians.
Rapid data collection decreases the period of time it takes to get faster diagnosis and intervention.

EEG is Everywhere: Even Rural Hospitals

EEG in healthcare can be found in services in rural hospitals across the U.S. are often limited due to a shortage of trained EEG technologists and neurologists.

Zeto addresses this challenge by enabling any healthcare provider or member of the medical staff to initiate EEG when needed, with seamless access to remote EEG reading services through our cloud platform.

Greenwood Leflore Hospital, a small community hospital in Greenwood, Mississippi, has been using Zeto EEG for routine EEGs. One of the key benefits they have noted is the significantly faster turnaround time for reading and interpreting EEG tests, with results now available the same day.

Why It Matters:

Patients in remote areas often face long commutes for advanced neurological care. Zeto’s portable EEG bridges the gap by bringing diagnostics directly to them.

Why are rural hospitals choosing Zeto EEG:

Expands access to advanced neurological care for rural patients in emergency (such as post brain injury) and non-emergency settings.
Reduces financial and logistical burdens associated with patient transfers.
Promotes healthcare equity by enabling local hospitals to provide specialized care.

“The biggest challenge of getting EEGs done in small community hospitals is the lack of EEG technologists. This lack of EEG technicians incentivizes ordering physicians to just send patients to a metropolitan hospital for EEG testing.” – Steven Robinson, director of cardiopulmonary care, Greenwood Leflore Hospital.

Bring EEG to Neurology Offices and Clinics

Zeto is commonly used in neurology offices due to its ease of use, with many customers noting shorter wait times for testing and improved patient experience. Dr. Randy Baculi from RHB Neuro shared his experience:

“In the short term, we quickly cleared a backlog of 100+ patients, including new ones, within just a few weeks. In the long term, the system’s ease of use means we’re no longer limited by the availability of specific staff members, ensuring essential diagnostics are completed on time..”

Full story: Case Study: Zeto’s Modern EEG at RHBNeuro | ZETO

Why It Matters:

Outpatient EEG procedures are often delayed due to complex setups and staffing shortages. Zeto simplifies the process, making it feasible to conduct more EEGs in less time and on an outpatient basis.

Key Benefits:

Gel-free headset for increased patient comfort.
Quick setup reduces appointment durations and increases throughput.
Can be operated by medical assistants, freeing neurologists for more critical tasks.

Watch how RHB uses Zeto at its clinic:

Bring EEG to Pediatric Neurology

Children often find traditional EEGs in healthcare settings uncomfortable due to gel applications and restrictive equipment. Zeto’s design prioritizes comfort, making EEG sessions more child-friendly. Pediatric neurologists who implemented Zeto report that the setup is fast and easy.

Key Benefits:

Gel-free electrodes eliminate the need for hair alterations.
Reliable data capture, even for active or restless children.
Faster setup reduces waiting times and anxiety.

Read our interview with Dr. Christina M. Patterson, Director of Epilepsy and EEG Services at UPMC Children’s Hospital of Pittsburgh, on how her team incorporates Zeto into pediatric EEG care.

Bring EEG to Ambulances

There is currently no effective way to assess brain injuries or perform brain monitoring in an ambulatory environment. However, early diagnosis during transport can significantly improve patient outcomes. Zeto’s latest EEG system, ONE, enables emergency responders to begin neurological assessments to the ambulance or helicopter, on the way to the hospital.

Key Benefits:

Portable EEG system can be used inside ambulances.
Provides high-quality data capture during transport.
Enables pre-hospital interventions that can save lives.

FDA Cleared: ONE is FDA-cleared for use in both air and ground transport, setting a new standard for mobile neurological care.

EEG in Concert Halls: The Music-in-Medicine Initiative at MD Anderson

Zeto EEG has been used to study the neurological effects of music therapy on patient recovery and well-being. We see this study with the pioneering work of Dr. Mei Rui, Director of Music-in-Medicine at MD Anderson Cancer Center, who used Zeto EEG to explore how classical music influences brain recovery. She believed that by capturing brain waves and their activity during performances, clinicians can unlock new therapeutic pathways for a range of neurological conditions.

Research has shown that music can significantly impact brain activity via neuroplasticity and emotional regulation. By bringing EEG into live music therapy sessions, researchers can better understand these neurological responses in real time.

Why MD Anderson Chose Zeto’s EEG:

Portable, gel-free design makes for ease of use and wearing for unconventional settings like music halls.
Non-invasive, quick setup that doesn’t interfere with the therapy session and can be easily set up by any healthcare provider.
Real-time data collection on brain activity for more impactful research outcomes.

Bring EEG to Research Labs – University of Rochester Medical Center

EEG systems are employed in research to study neurological activity and electrical patterns in experimental settings. Dr. Ram Haddas, a director of UR Medicine Motion Labs at the University of Rochester, shared how Zeto’s EEG enabled them to conduct more seamless studies on brainwave activity without subjecting participants to traditional EEG discomfort.

Why It Matters:

Research labs require reliable data without cumbersome setups. Zeto enables researchers to focus on their experiments rather than technical issues.

Key Benefits:

High-quality, reliable data collection to support robust research.
Portable and easy-to-use system with no need for gel or extensive preparation.
Compatible with all hair types, ensuring inclusivity in participant recruitment.

Click here to see Dr. Ram Haddas in action.

Bring EEG to Neurofeedback Clinics

Neurofeedback sessions often require multiple visits. A quick, comfortable EEG setup ensures patients can seamlessly fit sessions into their schedules.

Key Benefits:

Gel-free, quick setup minimizes patient discomfort.
Portable design enables for frequent, non-disruptive sessions.
Perfect for lunch-break appointments.

Bring EEG to Senior Living Communities

Early detection of cognitive decline can improve quality of life for seniors. However, EEG tests can be uncomfortable for older adults. Zeto’s gentle design addresses this challenge.

Key Benefits:

Soft-tipped electrodes are gentle on hair and scalp.
Quick setup without gel or skin abrasion reduces stress and discomfort for patients.
Enables routine cognitive assessments without disrupting daily routines.

Bring EEG to Contract Research Organizations (CROs)

Clinical trials require consistent, reliable data across various sites and patient populations. Zeto provides an efficient solution for brain monitoring in research.

Key Benefits:

Reliable, high-quality data collection.
Simplified workflows for research teams.
Compatible with diverse hair types and patient profiles.

Bring EEG to Sports Arenas – Monitoring Athletes’ Brain Health

Real-time brain monitoring can help protect athletes from long-term neurological damage by providing immediate insights during games.

Key Benefits:

Portable systems for on-site brain health assessments.
Real-time data collection supports safer sports practices.
Reduces the risk of undiagnosed concussions.

Breaking Boundaries in Brain Monitoring

Zeto is making EEG more accessible than ever – bridging the gap between advanced technology and everyday care settings. Our innovation and commitment to accessibility empower practitioners and researchers to break new ground in brain health.

Take the Next Step: Explore how Zeto can transform your approach to brain monitoring or collaborate with us to pioneer new applications.

Whether it’s in hospitals, research labs, or unexpected places like music halls, Zeto’s EEG technology is reshaping the future of brain health and neuroscience.

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Simplifying Routine EEGs: Zeto Improves Care for Neurology Practices

Routine EEGs are one of the cornerstones of neurological care^[1], yet traditional EEG systems often create unnecessary hurdles. It enables non-emergency diagnosis, extended follow-up of many types of neurological conditions, and the performance of non-emergent EEGs.

For practices with limited resources there can be significant scheduling constraints (and no possibility of scheduling many consecutive patients) to messy gels, sticky pastes, and time-consuming set-up processes, the old way of doing things isn’t just inefficient—it’s inconvenient for patients, eeg technicians and medical providers.

Enter Zeto WR19 EEG headset: a wireless, no-gel EEG solution that’s reshaping how neurologists approach routine testing.

Here’s how Zeto transforms the routine EEG experience and contributes to improving outcomes for doctors, patients, and practices:

1. EEG Solutions When Techs Aren’t Available

EEG Technicians are considered the gold standard for EEG performance, but they’re not always available. Zeto offers flexibility to EEG workflows, enabling medical assistants (MAs) to perform tests when needed. This can help practices reduce reliance on strict scheduling, making it easier to conduct EEGs without waiting for technician availability.

Benefits of Zeto for Routine EEG include:

Reduced scheduling complexity: Patients can have their EEG performed during regular office visits without the need to schedule several weeks out. Due to the ease of set-up and lack of cleanup needed, an office can schedule consecutive EEGs, maximizing their resources.
Enhanced flexibility: EEGs can be offered on-demand, streamlining workflow and reducing delays in diagnosis.
Improved patient compliance: By eliminating scheduling barriers and increasing patient comfort during the recording, patients are more likely to follow through with testing.

“I love it because our MAs (medical assistants), who were trained by the Zeto team, can set up and run the EEG studies. If they ever have issues, I step in to troubleshoot, but this is really rare. We have been able to work more efficiently with the limited resources we have, which is important because I am in a multispecialty private practice group.” – Dr. Komal Rastogi, Granger Medical Clinic.

2. Five-Minute Setup and Ease of Use

Zeto’s wireless, rapid EEG system is designed for efficiency in routine EEG use. The headset enables quick and easy setup in about 5 minutes, meaning less time preparing for the test and more time focusing on the patient. The no-gel electrodes eliminate the hassle of cleanup, and removal is just as simple, taking only one minute.

Why Ease of EEG Setup Matters:

Faster setup means less time preparing for the test and more time focusing on patient care.
The streamlined process enables practices to serve more patients in a day, improving patient care and speeding up clinical diagnosis.
Faster testing means patients spend less time in the office, which they appreciate.

“The setup for routine EEG has decreased to 5-10 minutes from previous durations of 30 minutes to 1 hour. Quality of both EEG and video is very impressive.” – Dr. Raj Gupta, San Jose Pacific Neurology Center PC.

3. No Gel, No Mess, More Patient Comfort

Gone are the days of sticky gels and lengthy cleanup times. Zeto’s no-gel system^[2] makes EEGs more comfortable for patients and easier for staff.

Patient benefits include:

Comfort: Without messy gels, patients don’t have to deal with the discomfort and inconvenience of washing their hair after the test.
Convenience: Patients can resume their day – whether going back to work, school, or home – immediately after the procedure.

This improved patient experience increases compliance with testing, making it easier for neurologists to provide timely care.

“Patients find the experience quicker and more streamlined, resulting in shorter visits compared to traditional setups. Overall, they respond positively to the technology. I have personally worn the Zeto headset for extended periods and can attest to its comfort.” – Dr. Christina M. Patterson, UPMC

4. Remote Access for Results, Anytime, Anywhere

Zeto’s cloud-based platform enables neurologists to access EEG results remotely^[3], providing flexibility. This makes it possible for tests to be performed in one location while neurologists review the results if needed in real time from another, facilitating faster diagnoses and streamlined workflows.

Benefits for neurologists:

Efficient workflows: No need to be physically present to review results and make a diagnosis.
Faster diagnoses: Immediate access to EEG studies speeds up the diagnostic process.

“I’ve been remotely reading EEGs done by the Zeto EEG headset for one of my local colleagues through Zeto’s EEG cloud platform since the beginning of 2022. How it works: EEGs are done in the clinic here in San Diego by trained staff. The EEG is streamed and saved in real-time to the Zeto cloud and I receive a notification when the recording is finished. At that point, I go online, read the EEG study, and prepare the report. Overall, the process is easy, fast, and straightforward.” – Dr. Boris Khamishon, Neurology San Diego

5. Transforming Neurology Workflows

By integrating Zeto into their practices, neurologists have found their workflows become more efficient, patient-friendly, and seamless. The ability to offer on-demand EEGs keeps things running smoothly and increases the speed of care.

Key impacts include:

Increased patient compliance: Patients are more likely to follow through with testing when it’s convenient and hassle-free.
Streamlined care: On-demand EEGs eliminate bottlenecks, enabling for faster diagnoses and improved outcomes.
Improved patient care: Timely EEG testing ensures patients receive the diagnostics they need without unnecessary delays, enhancing treatment planning and overall care quality.

“In the short term, we were able to quickly address a backlog of 100+ patients (and incoming new ones) within just a few weeks. In the long term, with how easy the system is to use, we are not bottlenecked to only certain staff members and their availability to utilize the device and ensure essential diagnostics were getting completed in a timely manner.” – Dr. Randi Baculi, RHBNeuro

6. Perfect for Solo Neurologists: Ease of Use That Saves Time and Costs

For solo neurologists, Zeto’s intuitive design makes performing EEG studies seamless. The headset is easy to apply with minimal artifacts^[4], enabling practitioners to focus on patient care without the need for additional staff or complicated scheduling.

Benefits include:

Increased efficiency: Solo practitioners can perform EEGs independently without needing to rely on additional staff, and use the time between studies for administrative tasks or patient care.
Flexibility: Ideal for part-time neurologists or those performing a limited number of studies per week.
Accessible support: Zeto offers easy access to technical assistance for troubleshooting when needed.

“I’m my own technician. I work part-time and perform 2 to 4 EEG studies a week, or about 12-15 studies a month. Technical assistance is easy when I have questions. It’s easy to use and maneuver. I usually read the results immediately after seeing patients and share the results in near real-time.” Dr. Virginia Thornley, Elite Neurology

7. Cloud-Based Software: Seamless and Up-to-Date Technology

Zeto’s cloud platform ensures that its software is always up-to-date, requiring minimal IT expertise or budget.

Benefits include:

User-friendly interface: The intuitive design makes reading EEGs straightforward and accessible.
Cross-device compatibility: Works effortlessly across laptops, phones, tablets, and desktop computers.
Streamlined accessibility: The cloud system provides reliable access, eliminating the need for complex setups or maintenance.

“The cloud interface is truly wonderful – user-friendly, easy to access, and visually appealing. I’ve used it on various devices, and it has consistently provided a seamless and headache-free experience.” Dr. Christina M. Patterson, UPMC

Zeto’s cloud-based platform meets stringent data security standards, such as HIPAA compliance, ensuring patient data is safe, accessible, and protected.

8. Report Writer: Designed with Neurologists in Mind

Zeto’s report writer features customizable templates that meet the specific needs of neurologists, enabling easy adjustments.

Benefits include:

Time-saving templates: Streamlined templates reduce the time spent on documentation.
Accessibility: Reports can be reviewed and adjusted from any device with internet access using the same login credentials.
Flexibility: Neurologists can adapt templates to align with individual practice preferences or patient needs.

“The biggest advantage is the Zeto report writer. The template features for the report are designed perfectly for a neurologist’s needs, and it’s very easy to make adjustments. The program is also easy to maneuver, and you can read the EEGs from any computer or device with a stable internet connection using the same login credentials.” – Dr. Boris Khamishon, Neurology San Diego

9. Accommodates All Hair Types

Zeto’s innovative electrode design eliminates barriers for patients with thick, curly, or styled hair, such as braids or dreadlocks.

Benefits include:

Patient comfort: No need for patients to alter or remove hairstyles, reducing stress and preserving dignity.
Cultural inclusivity: Accommodates protective hairstyles often tied to culture and identity.
Unique electrodes: Zeto’s patented electrodes can move past braids, cornrows, twists, or dreadlocks up to 1 inch thick and even work with thicker hair bundles.

We’ve written an entire blog on this topic: Textured Hair EEGs: Accessibility for All Hair Types

10. Signal Quality on Par with Traditional EEG Systems

Zeto is committed to delivering high-quality EEG brain monitoring results. With full-montage 10-20 electrode placement and advanced technologies such as Active Electrode Technology (AET) and Dynamic Noise Cancellation (DNC), Zeto provides data that is non-inferior to traditional EEG systems.

Benefits include:

Reliable results: Signal quality is the same as traditional EEG systems but the setup is easier and faster and no gel is included.
Evidence-backed performance: Clinical studies across 50 subjects demonstrated parity between Zeto EEG (zEEG) and clinical EEG (cEEG) systems.

“I like the idea of quick setup using soft gel electrodes like Zeto. It’s an easy & efficient way to do quality routine video EEGs”. Dr. Jaivir S. Rathore, Falcon Advanced Neurology Center.

For a deeper dive into Zeto’s signal quality, read our article, “Comparison of Dry Electrode EEG System with Conventional EEG System,” or review the abstract, “Technical Validation of the Zeto Wireless, Dry Electrode EEG System,” presented at the American Epilepsy Society.

Zeto’s signal quality meets the performance and technical standards outlined in EEG Guidelines provided by American Clinical Neurophysiology Society (ACNS).

The Future of Routine EEGs is Here

Zeto’s WR19 EEG system is more than a technological upgrade — it’s a practical solution that addresses the inefficiencies of traditional EEG workflows. By making EEGs faster, more comfortable, and more accessible, Zeto is helping neurologists provide better care for their patients.

Take advantage of Zeto’s end-of-year offer for neurology practices: upgrade your routine EEG workflow with our wireless, no-gel EEG system by the end of the year and enjoy the . Don’t miss this limited-time opportunity to revolutionize patient care and streamline your practice — offer ends December 20th, 2024!

References:

Worrell, G. A., Lagerlund, T. D., & Buchhalter, J. R. (2002). Role and Limitations of Routine and Ambulatory Scalp Electroencephalography in Diagnosing and Managing Seizures. Symposium on Seizures, 77(9), 991–998.
Sensors (Basel). (2014, July 18). Dry EEG Electrodes – PMC, 14(7), 12847–12870. doi: 10.3390/s140712847
Reider-Demer, M., & Shah, V. (2019, October). Telemedicine & Epilepsy: Your Smartphone Is Not Just for Communication – It Can Be Your Medical Care on the Go! Practical Neurology.
Lopez-Gordo, M. A., Sanchez-Morillo, D., & Pelayo Valle, F. (n.d.). Common Artifacts During EEG Recording. In Electroencephalography (EEG): An Introductory Text and Atlas of Normal and Abnormal Findings in Adults, Children, and Infants. NCBI Bookshelf.

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Textured Hair EEGs: Accessibility for All Hair Types

Getting an EEG shouldn’t be a hassle – no matter your hairstyle. For most patients, an EEG test typically requires no special preparation. However, for individuals with curly hair, textured hair or specific hairstyles, such as braids, dreadlocks, cornrows, twists, hair extensions or coily/kinky curly hair, the setup process can be more challenging than it needs to be. Thanks to innovative technology by Zeto, there’s a solution that makes textured hair EEG accessible and efficient for everyone.

Understanding Hair Types

Before addressing the challenges and solutions, it’s important to understand that hair types vary widely based on texture and curl patterns. The commonly recognized Andre Walker Hair Typing System classifies hair into four main types:

Type 3 and Type 4 hair, in particular, tend to be thicker, curlier, or kinkier, which can present unique challenges for textured hair EEG setups. Additionally, protective hairstyles such as braids, cornrows, and dreadlocks further complicate traditional EEG setups. For many patients, even getting a test can be difficult or uncomfortable, creating unnecessary barriers to essential healthcare.

EEG and Hair Diversity: The Urgent Need for Inclusive Solutions

For decades, EEG technology has not been inclusive of everyone. Traditional EEG electrodes are designed to sit flat on the scalp, which is especially challenging for people with thick, curly hair or dreadlocks. The process can become even more difficult, requiring technologists to ask patients to alter or remove their hairstyle to achieve quality EEG data.

Imagine being told that you need to take down intricate braids or cut your dreadlocks – hairstyles often deeply tied to culture, identity, and personal expression – just to undergo an EEG. What may seem like a minor inconvenience to some can become a major obstacle to others, delaying critical diagnostic tests and adding stress to an already daunting medical experience.

This issue has disproportionately impacted patients whose natural hair types and protective hairstyles are often incompatible with the rigid requirements of traditional EEG technology. As a result, many patients have encountered frustrating barriers to accessing the care they need.

Zeto Offers Textured Hair EEG: EEGs That Work for All Hair Types

The good news is that Zeto EEG technology is removing these barriers. Zeto’s wireless textured hair EEG headsets are designed to accommodate all hair types, from straight and wavy to curly and coily, including protective styles like dreadlocks, cornrows, and braids.

Unlike traditional EEG systems, Zeto headsets do not require the use of abrasive pastes or applications of messy electrolytes to obtain accurate readings. Instead, it sits comfortably on the head, regardless of hair volume, texture, or style. This ensures that patients with textured hair or complex hairstyles no longer need to worry about altering their hair for the test.

With Zeto, EEGs are no longer a stressful ordeal but a straightforward, accessible solution for all patients.

The photos illustrate the flexibility of dry electrodes used in the Zeto EEG system. Any of the three bristles touching the skin would provide sufficient skin-to-electrode contact for stable signal recording.

Zeto’s Unique Electrodes

Zeto’s textured hair EEG electrodes are designed to work with a wide variety of hair types and densities. Flat electrodes are ideal for areas without hair, such as the forehead. Taller electrodes with legs are designed to navigate through thicker hair, allowing for easy placement on the scalp, even with complex hairstyles.

Zeto’s patented electrode tips seamlessly move through hair and braids without leaving behind any sticky residue. The electrodes are capable of moving past braids, cornrows, twists, or dreadlocks up to 1 inch thick, and can even work with thicker hair bundles, depending on the style.

Zeto offers EEG solution for protective hairstyles

Convenient for EEG Technologists

Zeto makes life easier for EEG technicians by eliminating time-consuming skin preparation and messy gels. The setup is quick and efficient, even for patients with type 4 kinky/coily hair, taking just 5-10 minutes at most. Zeto’s headsets come with handy light-based signal quality indicators built into each electrode that lets users know when the electrodes have a good connection (green light) or if they need a little adjustment (Red, orange, or yellow ). The adjustment is made by rotating and repositioning the electrode, to make sure they’re properly touching the scalp.

Comfortable for Patients

Zeto provides a significantly better EEG experience for patients. The setup is faster and more comfortable, with no sticky gels or adhesives to wash out afterward. There’s no need for special preparation or skin abrasion, which minimizes the risk of irritation or discomfort. Additionally, Zeto’s electrodes are single-use, eliminating the risk of cross-contamination. Patients enjoy a hassle-free experience with precise and reliable results, all without being asked to change or remove their hairstyle.

Many patients have shared that after their Zeto EEG test, they could go about their day as planned, without the need to wash or restyle their hair.

Remaining Limitations

While Zeto’s EEG technology works with most hairstyles, blocking the electrode tips from contacting the scalp may still prevent accurate recordings. However, weaves or sew-ins that allow scalp contact are generally not an issue for Zeto’s electrodes.

EEGs should be accessible to everyone, regardless of hairstyle. Zeto is proud to offer a solution that makes brain monitoring more inclusive, comfortable, and efficient. By offering innovative EEG headsets with unique electrodes, Zeto ensures that no patient is left behind due to their hair type or style.

From WR19 to Zeto ONE: Inclusivity and Reliability Across 100,000 Studies

Zeto has two innovative EEG headsets: the WR19 for EEG studies up to 6 hours and the Zeto ONE for continuous monitoring for 24+ hours. Both headsets use the same electrode technology and work seamlessly with textured hairstyles, ensuring reliable and high-quality EEG recordings.

Zeto EEG headsets, WR19 and Zeto ONE, offer EEG solutions for all hair types.

Zeto’s commitment to accommodating various hair types and styles began with the clearance of our first-generation WR19 device in 2018. From the outset, the WR19 was capable of recording EEGs on patients with diverse hairstyles and hair types without requiring additional effort or compromising signal quality. This dedication to inclusivity and performance was carried forward into the design of our next-generation device, the Zeto ONE EEG system, launched in 2024.

Out of the 90,000 EEGs conducted using Zeto’s EEG system across over 200 healthcare facilities in the U.S., there has not been a single complaint or failure related to hair type.

Preserve the Style, Skip the Paste

To find out more about Zeto’s patient-friendly EEG technology and how it can work for you, explore our website or schedule a consultation with our team. Zeto is committed to making brain monitoring accessible for everyone, no matter your hair type or style.

We explored the compatibility of Zeto EEG with different hair types, including braids, cornrows, and kinky/coily hair, in a recent webinar. During the webinar, we also conducted live demos with various hairstyles to demonstrate how well Zeto EEG works. Be sure to check it out!

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