Zeto's wireless EEG machine


Zeto to Showcase Technology to Make EEG Brain Monitoring More Accessible for New Providers and in Rural and Underserved Communities at 2022 AAN Annual Meeting

Today, Zeto, Inc. announced its participation in the 2022 American Academy of Neurology Annual Meeting, an event for neurologists and neuroscientists, taking place April 2-7, 2022.

The AAN Annual Meeting strives to promote the highest quality patient-centered neurologic care, assert the value of neurology to policymakers and other major stakeholders, and expand the neurology workforce to meet future needs for patient care.

“We are excited to be back in person for the 2022 AAN Annual Meeting. The past two years put a tremendous burden on many private practices and hospitals. In large parts of the U.S., hiring technologists required to record EEGs has been an everyday challenge due to the pandemic. That makes new providers or providers in rural and traditionally underserved communities struggle to offer crucial EEG tests at their own locations.

“For that very reason, Zeto will showcase our FDA-cleared EEG monitoring technology that enables providers to offer brain monitoring even without traditionally trained EEG technologists. Zeto EEG technology helps save valuable time and resources, while not compromising clinical standards. Neurologists can perform an EEG rapidly, even without an EEG technologist on site. At no upfront costs, and for as low as $65 per patient, providers can record full-montage EEG in under five minutes at the same quality as conventional gel EEG. Included in that per-patient fee are an EEG amplifier, consumables, cloud software with storage, video integration, warranty, training, and a powerful report writing tool. Optional EEG reading services further support clinical decision-making. In the past two years, we saw countless examples of how Zeto technology helped support providers to make EEG more available even under the most challenging circumstances,” said Florian Strelzyk, Chief Sales Officer at Zeto.

According to statistics, one in three patients recovering from Covid-19 may experience neurological or psychological effects from their infections, reflecting a growing consensus that the disease can have lasting effects on the brain.

The AAN Annual Meeting is the largest meeting and exhibition in the world to share common scientific and clinical interests in neurology.

About Zeto

Zeto, Inc. is an award-winning privately held medical technology company located in Santa Clara, CA, focused on transforming the way electroencephalography (EEG) is performed at hospitals and clinics. Zeto’s revolutionary FDA-cleared EEG headset and cloud platform bring the traditional EEG procedure to the 21st century. The company plans to leverage its hardware and software technology to improve noninvasive monitoring of the brain’s electrical activity and achieve better outcomes for neurological conditions such as epilepsy, sleep disorders, autism, stroke and concussion.

To learn more about our products, please visit: www.zetoinc.com or email us at info@zetoinc.com


Source: https://www.newswire.com/news/zeto-to-showcase-technology-to-make-eeg-brain-monitoring-more-21675785

Faster & Better EEG Tests with Zeto Health Technology Podcast with Aswin Gunasekar, CEO & Founder, Zeto

For the August installment of the Healthtech Leader of the Month series, we interviewed Aswin Gunasekar, founder and CEO of Zeto. Zeto is a device-driven platform for acquiring, accessing, and interpreting electroencephalograms (EEGs). An EEG is a test used to evaluate electrical activity in the brain.

Zeto Offers a Seamless EEG Experience

Zeto is the first true dry electrode EEG system cleared by the FDA for clinical use. Founder and CEO Aswin Gunasekar breaks down the inefficiencies of traditional EEG.  “If you look at it, the value chain from acquiring the EEG, accessing the data, interpreting the info, and then diagnosing; all these steps were broken,” he says. “The elaborate set up process makes EEG inaccessible. If you need a trained operator, who needs to go through a 10-month certification program just to do this procedure, that’s an instant bottleneck.”
Clinical EEG is arduous: a trained EEG technologist must measure for exact electrode locations, abrade the skin, apply conductive paste, and glue each electrode to the scalp before recording the electrical activity. EEGs are used to diagnose conditions such as brain tumors, inflammation of the brain, seizure disorders including epilepsy, and more.
Zeto’s first product is a wireless, adjustable headset that allows for EEG acquisition with no skin prep or cleanup. Physicians receive live remote viewing of video EEG through the cloud. Zeto’s integrated platform also offers data management and analysis tools for a seamless experience of acquiring EEG, enabling physicians to deliver better neurological care to patients.

Three Lessons Learned

When Aswin Gunasekar worked as an electrical engineer at AMD, designing semiconductor chips, he learned to ask himself: how does the piece that you’re working on fit into the bigger puzzle? “I did a lot of statistical analysis on yield of chips,” he says. “You can get lost in the weeds, or you can put the pieces together and say ‘you can design for this.’”
In the capstone class for his MBA at UT Austin, Aswin formed a team that was eager to solve a pressing issue in healthcare. “My cousin’s story came up. My cousin grew up with epilepsy in the 90s. It took a big toll on his mental and social development, because he was being overdosed on anti-epileptic drugs,” Aswin says. “The drugs are very coarse in nature; they’re not that fine-tuned. His development could have been much better had better tools and care existed back then. We started digging deeper and discovered that EEG is the gold standard for diagnosing conditions like seizures and epilepsy. We instantly knew that it shouldn’t be done the way it’s being done right now, by gluing wires onto the scalp.”
Aswin and the team began developing a headset with soft tip electrodes. “For us, conceptually, I knew there was nothing in science that limited us from doing this. But I knew it would be a journey of constant iterative learning,” he says. Here are a few things Aswin has learned on the way.

Lesson #1: Protect your psychology as a leader.

“Your psychology as a leader is 75% of the ball game. It’s about managing your state, not just about positive thinking. If you are locked in on something that you absolutely need to get done, from a destination standpoint, from a vision standpoint, you will find a way. Never go easy on that,” Aswin says. He recalls how difficult it was as a first-time entrepreneur to find Zeto’s first supporters.
In 2016, Aswin pitched at a Shark Tank competition organized by the Epilepsy Foundation of America, demonstrating Zeto’s prototype on the judges. They won both the People’s Choice and Judge’s Choice awards, raising their first check and confirming that they were on the right path. Aswin cites how important that first inflection point was in boosting their confidence. “Without clarity of thought and managing your psychology as a leader, you’re not going to be able to inspire people to join forces with you,” he says.

Lesson #2: Think big but execute small.

“Think big but execute in small steps. It’s also self-motivating; you can celebrate those wins and it motivates the people in your team and it’ll motivate more people to come in and join you,” Aswin says. One of his big-picture goals for Zeto is to bring more companies onto their platform and to give valuable information about the brain to clinical providers and neuroscientists. He plans to get there with the same strategy he’s used from the start: take it step by step.
“Plan and execute. Take out the biggest risk first. Always keep chopping away at that,” he says. “It doesn’t matter whether it’s a technical issue, a commercial traction issue, it’s the same thing: take that problem, break it down into pieces, understand the biggest risk within that bucket, and knock that down first. And then move to the next one.”

Lesson #3: Hire for grit.

“The ground floor, especially the first hundred people in a company, are so important to how the company lives, breathes, and develops into an organism of its own,” Aswin says. “I’m personally involved with every little hire; it doesn’t matter whether it’s a consultant, or part-time, or full-time; I’ll be involved with the first three hundred people.” Aswin looks for people who not only have the skillset and experience, but for those who demonstrate the “startup spirit;” the ability to persevere, to get knocked down and get back up. “It’s not just resume. It’s not just their experience and their accomplishments, you also need to hire for grit and tenacity,” he says. “You don’t see that just on the resume. We actively try to unearth that.”

Beyond the Business Books: Final Thoughts

One of the ways that Aswin wants to grow as a CEO is by growing overall as a person. “I’ve always learned the most from unconnected sources. I think I’m past the stage where I just go read business books. Those are good too, but I think the world is a little bit more complex than that,” Aswin says. “If we are taking a product and selling it to a customer, we are selling it to a human being who has their own life going on. How are we presenting our product as they go through their lives? That kind of learning will come from a better understanding of the nuances of the world.”

Zeto’s next goal is to expand its product portfolio and make their cloud infrastructure more capable. “Right now, Zeto is extremely useful for short-term EEG, but brain monitoring is a lot bigger,” Aswin says. “We need to make products that will allow people to be monitored for hours or days on end. There is a real need here, and we’re talking about brain monitoring! Once you give people a better platform, they’re going to do wonderful things with it.”

Listen to Aswin’s episode on the Health Technology Podcast.

Source: https://rosenmaninstitute.org/healthtech-leaders/healthtech-leader-of-the-month-aswin-gunasekar-ceo-zeto/

Wireless EEG for Fast Prep and Easy Use: Q&A with Aswin Gunasekar, CEO of Zeto

Electroencephalography (EEG) devices are incredibly helpful in diagnosing and monitoring certain brain disorders, such as epilepsy and strokes. However, they are not particularly user-friendly or convenient, with specialized technicians performing time consuming procedures, such as skin preparation, to get patients ready to undergo the procedure. A combination of messy gels and wires also makes for an uncomfortable and inconvenient experience for patients.

Woman wearing Zeto's wireless EEG machine

In response, Zeto Inc., a medtech startup based in California, has developed a new EEG device that sits on the head like a bicycle helmet. The headset does not require gels or pastes to function, and can transmit data wirelessly. The company claims that the new system can reduce setup times from the current 20-30 minutes required with conventional systems to just five minutes, potentially making the Zeto device very useful in emergency situations. Best of all, the headset does not require a specialized technician for setup and use, and so could be quickly applied by nursing staff or other clinicians.    

The device is currently being trialed at Methodist Le Bonheur Healthcare in Memphis, Tennessee, to see how it compares with traditional EEG equipment in a clinical setting.

Here’s a video intro from Zeto Inc. about the company’s technology:

Medgadget had the opportunity to talk to Aswin Gunasekar, Founder and CEO of Zeto Inc., about the technology:

Conn Hastings, MedgadgetPlease give us an overview of conventional EEG devices, and their limitations.

Aswin Gunasekar, Zeto: Conventional EEG devices require a trained EEG technologist to measure the head, mark electrode locations, abrade the skin, and apply paste and electrodes to the scalp, eventually tethering the patient to a box with wires. This procedure consumes time, requires technologists who need to be perpetually on-call, and puts the patients through a needlessly poor experience. The scarcity of EEG technologists makes the problem worse, and even unfeasible in many hospitals, emergency rooms and other outpatient settings. Essential features such as easy data access and remote interpretation remain unavailable for conventional EEG devices.

Zeto's wireless EEG machine

MedgadgetHow does the new device developed by Zeto compare with conventional EEG in terms of speed and ease of use?

Aswin Gunasekar: Zeto’s Instant EEG Platform (zEEG) provides the first FDA cleared zero-prep, wireless, dry electrode headset that can be used to perform a routine or urgent EEG anywhere without the need for a trained expert. The device is quickly and easily placed on the patient’s head much like a bicycle helmet. Data are streamed via a HIPAA compliant cloud platform that provides live viewing, tools for analysis and optional remote interpretation by neurologists. Time to interpretable EEG is typically 5 minutes with built-in positioning as per the international 10-20 EEG system. Total overhead time for set up and patient clean up with the Zeto headset is typically under 10 mins compared to over 45 minutes with conventional EEG.

MedgadgetGiven the current pandemic, how does the Zeto EEG device help with reducing the potential for viral transmission?

Aswin Gunasekar: Due to the convenience and simplicity of Zeto’s EEG technology, PPE and exposure time for healthcare workers is reduced significantly. The headset utilizes single-use, disposable electrodes and an optional liner which reduces contact between the patient and the reusable headset, reducing the risk of contamination. Zeto has not yet performed studies on reducing viral transmission. However, the faster setup, zero patient clean up and the ability to monitor the recording with live video from outside the room helps reduce exposure of staff. 

MedgadgetWhat types of mobile devices are compatible with the Zeto EEG device? Is the mobile interface easy to use?

Aswin Gunasekar: Most laptops, desktops and mobile devices capable of running the latest version of Google Chrome web-browser are compatible with the Zeto EEG device. Users of zEEG devices are provided with web-based access, an EEG study manager, video review, annotation features, time-frequency analysis, report generator, analytics and automated software upgrades. The mobile interface – as well as that of laptops and desktops – is simple, intuitive and easy-to-navigate.

MedgadgetHow are data transmitted and how do you deal with data security?

Aswin Gunasekar: The security of our customer and patient data is of foremost importance to us. Zeto employs Design, Technical, Physical and Compliance controls to ensure the integrity and availability of the data on our platform. Data are transmitted with industry-standard AES encryption on the move and at rest. Data access is controlled through strict authentication and authorization protocols. The Zeto Cloud Platform is compliant to HIPAA rules, FDA 21CFR820 cybersecurity requirements and NIST SP800-53 Cybersecurity controls, and all Zeto personnel are HIPAA trained. 

MedgadgetPlease give us an overview of the current trial of the device at Methodist Le Bonheur Healthcare in Memphis, Tennessee.

Aswin Gunasekar: Methodist Le Bonheur Healthcare is the very first hospital system globally to participate in the ongoing trial that compares the capabilities and benefits of Zeto’s EEG technology against traditional EEGs. The trial conducts 3 phases, namely 1) Inpatient (ICU) EEG for detecting subclinical seizures and status epilepticus, 2) Outpatient EEG with trained EEG technologists and 3) Outpatient EEG with staff who are not certified technologists. The current trial could result in a clinical breakthrough that transforms how we approach EEGs in the future. 

Source – https://www.medgadget.com/2020/09/wireless-eeg-for-reduced-prep-time-and-non-specialist-use-interview-with-aswin-gunasekar-ceo-of-zeto.html

HealthTech Arkansas names five early-stage companies for latest cohort

HealthTech Arkansas announced the five early-stage companies selected for the 2020 HealthTech Arkansas healthcare accelerator.

The accelerator is supported by 11 Arkansas healthcare organizations, including Arkansas Children’s Hospital, Arkansas Heart Hospital, Arkansas Urology, Baptist Health, CHI St. Vincent, Conway Regional Health System, Mercy, OrthoArkansas, St. Bernards Healthcare, University of Arkansas for Medical Sciences, and Washington Regional Medical Center.

Representatives from each of the 11 healthcare providers interviewed applicants and selected companies with technologies that have the potential to advance innovation at their respective organizations. The five companies were selected from hundreds of applicants across 14 different countries and are headquartered across the country in California, Utah, and Pennsylvania.

The five companies are:

Astarte Medical, Yardly, Pa.
Astarte Medical is a precision nutrition company using software and predictive analytics to improve outcomes during the first 1,000 days of life. With an initial focus on preterm infants, Astarte Medical supports feeding protocols, practice, and decision-making in the neonatal ICU with a suite of digital tools and diagnostics designed to standardize feeding, optimize nutrition and quantify gut health.

nView Medical, Salt Lake City, Utah
The nView_s1 is an imaging system that provides instant 3D images in the OR with minimal radiation. Like a C-arm, the nView_s1 images from a stationary single position. Unlike a C-arm, novel AI reconstruction techniques allow it to provide 3D images.

Raydiant Oximetry, San Ramon, Calif.
Raydiant Oximetry has developed a non-invasive fetal pulse oximeter to directly monitor a fetus’s blood oxygen saturation during labor and delivery and provide the key missing vital sign that clinicians need to more accurately assess the baby’s health during childbirth.

Vena Vitals, Irvine, Calif.
Vena Vitals, Inc. is re-innovating the way blood pressure is monitored by using soft stretchable sensors that can conform to the body and accurately measure arterial pulse. Their technology provides the benefits of continuous, beat-to-beat blood pressure measurements, but in a non-invasive way.

Zeto, Santa Clara, Calif.
Zeto has taken a significant step towards simplifying EEG. The Zeto product is the first and only dry electrode EEG headset and cloud platform cleared by the FDA for clinical use.

“Our provider partners around the state are excited to introduce the new cohort companies to their teams and launch pilot programs that can make a difference in patient care,” said Jeff Stinson, director of HealthTech Arkansas. “We’ve expanded the applicant pool and the number of providers in our coalition in each of the three years at HealthTech Arkansas. The guaranteed pilot projects and clinical studies from our providers around the state are what differentiates us from any other program in the country.”

The cohort will participate in a program that provides them the opportunity to pilot solutions specifically identified by the 11 participating Arkansas healthcare groups as areas of opportunity within their organizations.

HealthTech Arkansas is a third-year accelerator program focused exclusively on provider engagement with early-stage companies and works with both Arkansas-based and out-of-state companies. The Arkansas Economic Development Commission awarded a grant to HealthTech Arkansas through a program designed to increase acceleration activities in targeted industries in the state.

Source – https://talkbusiness.net/2020/09/healthtech-arkansas-names-five-early-stage-companies-for-latest-cohort/

New study tests “first-of-its-kind” EEG device

A press release states that EEG (electroencephalogram) tests are conducted to detect problems in the brain that may be associated with certain brain disorders such as seizures, tumors or strokes. A typical EEG test consists of multiple electrodes attached to a patient’s scalp with adhesive. Those electrodes have several wires connected to an amplifier which further connects to a computer that measures and records the results.

The setup and removal of a typical EEG test takes between 20–30 minutes. This new US Food and Drug Administration (FDA)-approved product, called zEEG from Zeto, (headquartered in Santa Clara, USA), can be set up in less than five minutes; which offers a more efficient and comfortable experience for the patient.

The patient wears equipment that looks like a high-tech bicycle helmet. The electrodes do not need to be glued to the patient’s scalp, do not leave any residue on the patient and there are no wires connected to an amplifier or computer.

An EEG technician at Methodist University can now be more productive and perform more EEGs in a day. The EEG and video recording are uploaded to the cloud where a specialist can read them at their own convenience.

The ZETO Instant EEG has been beneficial in the midst of the unprecedented COVID-19 pandemic. Due to the convenience of this EEG technology, personal protective equipment (PPE) and exposure time for healthcare workers is reduced significantly. Fast setup and clean up decrease the exposure times for nurses and other care providers. The ZETO Instant EEG uses single-use electrodes which also reduces the risk of contamination.

Source – https://neuronewsinternational.com/new-eeg-device/

Methodist University Hospital Is First In The World To Participate In Groundbreaking EEG Study For Inpatients That Improves Brain Monitoring During the COVID-19 Crisis

MEMPHIS, Tenn., Aug. 4, 2020 /PRNewswire/ — Methodist Le Bonheur Healthcare (MLH) is the first hospital system globally to participate in a landmark study using a first-of-its-kind EEG device.

EEG stands for electroencephalogram. EEG tests are conducted to detect problems in the brain that may be associated with certain brain disorders such as seizures, tumors or strokes. A typical EEG test consists of multiple electrodes attached to a patient’s scalp with adhesive. Those electrodes have several wires connected to an amplifier which further connects to a computer that measures and records the results.

The setup and removal of a typical EEG test takes between 20-30 minutes. This new FDA-approved product, called zEEG from Zeto, Inc., headquartered in Santa Clara, CA, can be set up in less than five minutes; which offers a more efficient and comfortable experience for the patient.

The patient wears equipment that looks like a high-tech bicycle helmet. The electrodes do not need to be glued to the patient’s scalp, do not leave any residue on the patient and there are no wires connected to an amplifier or computer.

An EEG technician at Methodist University can now be more productive and perform more EEGs in a day. The EEG and video recording are uploaded to the cloud where a specialist can read them at their own convenience.

The ZETO Instant EEG has been beneficial in the midst of the unprecedented COVID-19 pandemic. Due to the convenience of this EEG technology, PPE and exposure time for healthcare workers is reduced significantly. Fast setup and clean up decrease the exposure times for nurses and other care providers. The ZETO Instant EEG uses single-use electrodes which also reduces the risk of contamination.

About Methodist Le Bonheur Healthcare

Based in Memphis, Tennessee, Methodist Le Bonheur Healthcare (MLH) has been caring for patients and families regardless of ability to pay for more than 100 years. Guided by roots in the United Methodist Church and founded in 1918 to help meet the growing need for quality healthcare in the greater Memphis area, MLH has grown from one hospital into a comprehensive healthcare system with 13,000 Associates supporting six hospitals, ambulatory surgery centers, outpatient facilities, hospice residence and physician practices serving communities across the Mid-South. From transplants and advanced heart procedures to expert neurology services and compassionate cancer care, MLH offers clinical expertise with a focus on improving every life we touch.

Source – https://www.prnewswire.com/news-releases/methodist-university-hospital-is-first-in-the-world-to-participate-in-groundbreaking-eeg-study-for-inpatients-that-improves-brain-monitoring-during-the-covid-19-crisis-301104852.html

Zeto Raises Series A Funding to Accelerate Commercialization Efforts of its Easy Use Electroencephalography (EEG) Headset and Software Platform

SANTA CLARA, Calif., March 10, 2020 /PRNewswire/ — Zeto, Inc., a privately held medical technology company that is transforming the Electroencephalography (EEG) experience for healthcare, today announced that it has raised $7.3 million in Series A financing led by Seraph Group and joined by Aphelion Capital, SV Tech Ventures and Shangbay Capital. Zeto raised $4 million previously in dilutive and non-dilutive funding. The new capital will be used to accelerate commercialization of its lead product, the zEEG headset and software platform, and develop new products to expand its portfolio. zEEG is the first true dry electrode EEG headset to be approved by the U.S. Food and Drug Administration (FDA) for clinical use.

“Since our commercial launch a few months ago, we added several customers who love the product and are utilizing it at high rates. We are glad to validate the strong product-market fit for zEEG. Inspired by the demand, we are excited to expand our commercial team and production capacity to serve our growing customer base,” said Aswin Gunasekar, MS, MBA, Chief Executive Officer and Founder of Zeto. “Our goal is to provide the most seamless and intelligent EEG experience for any clinical need. Current products are far behind what users need and Zeto is building a suite of convenient and intuitive products to eliminate the most time consuming and labor-intensive activities involved in traditional EEG. As a subsequent step, we plan to utilize artificial intelligence to not only supplement the reading physician with analytics and insight but also expand the diagnostic utility of EEG worldwide in areas of medicine where it has been underutilized.”

Zeto’s customer, Wave Neuroscience, Inc., said, “Our extensive intellectual property portfolio and business operations are built on award winning science and medical innovation. For us to achieve the high level of results we are committed to, we rely on partners that never rest in their quest to achieve the highest standards. Accessing an FDA compliant EEG device that performs at an uncompromising standard, allows for increased throughput and provides a user experience that rivals the latest technology assets, was very attractive to us. Zeto transformed the way we think about EEG capture by advancing technology further in the past two years than the industry had in the prior three or four decades. Zeto provides us the confidence, convenience and data quality that we rely on, day in and day out.”

“We believe a new era is around the corner when researchers can accelerate our understanding of the brain with this breakthrough device and software platform. It not only makes commercial sense, but also can serve as the infrastructure and library for neurological knowledge that leads to better diagnosis and treatment of brain disorders,” said Tuff Yen, CEO of Seraph Group, the lead investor.

“We are passionate about brainwaves, consider it a privilege to serve our customers and are committed to bringing great advancements for neurological care,” adds Aswin Gunasekar.

Source – https://www.prnewswire.com/news-releases/zeto-raises-series-a-funding-to-accelerate-commercialization-efforts-of-its-easy-use-electroencephalography-eeg-headset-and-software-platform-301020172.html

ZETO: Sensing Improvement in Neurological Data Processing

EEG is the gold standard for observing and characterizing neural activity, but patients are subject to lengthy and uncomfortable preparation for scans, and interpretation is subjective to the physician who reads it. Zeto has introduced a device designed for patient comfort and simple setup, which uses “active” dry electrodes capable of picking up cerebral activity with high digital resolution and less noise.

In Greek, the word zeto means “to live.” By that token, neural monitoring start-up Zeto Inc. was brought to life from the seed of a business school idea, with hopes of improving countless lives. Zeto’s CEO Aswin Gunasekar was in business school at the University of Texas, Austin, when he took an interest in epilepsy diagnosis after watching a family member battle the condition. Quickly realizing that the electroencephalogram (EEG), the gold standard for monitoring neural activity, has had few updates since its invention early in the 20th century, innovation was an immediate priority for Gunasekar.

Current EEG systems are uncomfortable for patients, inefficient due to their lengthy setup, and variably interpretable in their output. Leveraging years of experience as an electrical engineer developing microprocessors, Gunasekar conceived of a business plan for an easy-to-use EEG testing alternative, which helped his MBA team win the venture creation class’ competition in 2013.

Gunasekar continued to develop it as he moved to Silicon Valley to work for PwC. During this period, his idea shifted from a patient-use home monitoring device to a professional, clinical, medical device. As it is today, the Zeto solution incorporates feedback from several hundred patients, neurologists, and EEG technologists to ensure its practicality in addressing the biggest pain points of those who use it most frequently.

Traditional EEG is used to observe seizures and diagnose epilepsy, sleep disorders, autism, stroke, concussion, and more. Testing involves the placement of 20 electrodes on the scalp, abrading the surface of the skin to lower impedance and using viscous gel to improve conductivity in order to boost the signal detected. The process requires a specially trained technologist and can take up to two hours to yield just 30 minutes’ worth of test results, the rest of the time lost to preparation, adjustment and clean up. The signal, once recorded, is highly intricate with many discrete elements that are challenging to translate into useful information.

Current EEG systems are inherently expensive to operate and maintain with such cost drivers as the time consumed, labor, equipment, consumables, maintaining the digital infrastructure to allow remote access for physicians as well as storage and archiving of patient recordings. Consequently, additional expenditure is incurred for IT personnel, third-party software, and data retrieval. According to Gunasekar, the broken EEG value chain has led to underutilization of EEGs in most US hospitals and unavailability in many rural, emergency, and international settings.

Finally, there is also a high degree of subjectivity between readers of EEG output. Signals are often manually annotated in various formats, with the data largely unstructured and not machine learnable.

“Today, the burden of obtaining a good signal is completely on the EEG technologist,” Gunasekar says. The placement of the sensors, as well as the mitigation of peripheral electrical activity that clouds the brain signal

with noise, requires training and experience to perfect. Precision placement is also a priority, as the goal is to capture neuronal activity at precise regions of the brain.

With Zeto’s device, a headset that resembles a bicycle helmet, much of the finessing required with traditional

EEG systems is eliminated. The sensors, designed for patient comfort, are mounted on a semi-rigid but adjustable frame, positionableto precise locations and calibrated to work dry (sans coupling gel), with no skin preparation, through all types of hair. In addition to EEG, Zeto’s patent pending hardware contains an added ECG sensor as well as video and auxiliary inputs for comprehensive monitoringcapability. Three clinical evaluations across 50 patients and the FDA clearance have so far validated that the device is at least

as effective as standard EEG systems with a more patient-friendly design and proprietary techniques for signal enhancement. The latter includes

Active Electrode Technology, which preamplifies and conditions the neural signal at the source, and Dynamic

Noise Cancellation, which detects and removes noise in real time, as audio headphones with a similar purpose do. Zeto’s revolutionary hardware connects to its intuitive cloud software that enables a secure, evolving AI engine with machine learning capability (currently in development), which will allow it to improve continuously through use as it gains experience. First, the data are standardized into a functional, searchable format, then are processed by the software to generate autonomous reports and assistance to give new insights to the attending doctor. By bringing to market arguably the most significant advancement to EEG technology since its inception, Gunasekar is aiming to not only disrupt the market, but lead it.

“We want to aid physicians tremendously with the EEG diagnostic for the future,” says Gunasekar. In line with this pursuit, Zeto is offering EEG interpretation services by board-certified neurologists to bridge any gap in knowledge when examining a particular scan. The combination of human expertise and tireless machine assistance will maximize the potential for meaningful analysis, overcoming the complexity and subtlety of neural signals. This new approach, for example, can guide attention to an area of the brain with particularly relevant activity, and search for similar patterns and connectedness to other regions across extended periods. That may lead to a more thorough understanding of neurological interaction and afflictions.

Zeto is introducing the first EEG headset backed by a cloud system to be cleared by the FDA for clinical use,

according to Gunasekar, who notes that the company is currently preparing for a CE mark. Zeto’s revenues will come from a capital equipment or subscription model, considering the pay-as-you-go nature for cloud connection and support. All of the company’s manufacturing is completed in-house, with production capacity capable of exceeding a few hundred units per month.

Gunasekar notes that both thought leaders and marketing partners will be engaged to help push Zeto to the forefront of the conversation among hospitals and clinics. The ease of its use allows for a demonstration that proves the product’s effectiveness in minutes, underscoring the intuitiveness of the headset, and serving as an instant visual representation of its increased efficiency and comfort over traditional EEG solutions.

With over 20 million clinical EEG procedures performed each year globally, Zeto’s initial target application of

short-term routine scans represents a $1.5 billion market, while follow-on products will address a $4 billion longterm EEG sector, and eventually a $10 billion future market that can positively impact autism, stroke, and concussion.

By Gunasekar’s assessment, Zeto’s 19-person close-knit team is its engine of innovation. “We have an incredibly passionate team that is locked in on transforming this space,” he says, “but we will really be smiling once our product has made this important medical test available to millions of people in

the world who need it.” The company is currently in an A round of financing, seeking $12 million, to fund its imminent commercial launch with an oversubscribed order pipeline for 2019.

Source – MedTech Strategist