INVIZA®'s wearable tech is the result of 20+ years of R&D in sensors and energy harvesting. Our highly skilled team of electronics engineers and software experts have enabled us to become the world's first company to introduce INVIZA® Soles M1.0, a self-powered health and fitness tracker tech embedded in shoe insoles.
Wearables are electronic devices that are designed to be worn on the body, often as accessories or clothing items. They typically incorporate sensors and other technologies to track and monitor various aspects of the wearer's health, fitness, or daily activities.
Common examples of wearables include smartwatches, fitness trackers, smart glasses, and health monitoring devices, now including smart insoles. These devices often connect to a smartphone, tablet or other device via Bluetooth, Wi-Fi and LTE cellular allowing users and licensed medical professionals to access and analyze data about their health and fitness.
Wearables are becoming increasingly popular as people seek to track and monitor their health and fitness in real-time. They can help users set and achieve fitness goals, monitor their sleep patterns, track their calorie intake, and even detect early signs of certain medical conditions.
Wearable technology is also being used in a variety of industries, including healthcare, sports, and entertainment. For example, wearables can be used to monitor the vital signs of patients in a hospital or in an at-home setting (a.k.a. Hospital-at-Home "HaH") or to track the performance of athletes during training and competition.
Smart remote patient monitoring (RPM) insoles with non-invasive optical sensors are an innovative technology designed to provide comprehensive health monitoring capabilities through the foot. These insoles incorporate advanced optical sensors that can measure various physiological parameters with medical-grade accuracy, all while being able to accurately "see through" the user's socks. Plus, the insoles convert the patient's steps into electricity and it is stored on its rechargeable battery (see "Self-Charging? What is Energy Harvesting?" below).
The key physiological parameters that can be measured include heart rate (HR), resting heart rate (RHR), heart rate variability (HRV), respiratory rate (RR), percentage of blood oxygen saturation (SpO2), and body temperature. By leveraging optical sensing technology, these insoles enable continuous monitoring of these vital signs without the need for invasive methods or additional wearable devices.
In addition to the optical sensors, the smart RPM insoles are equipped with force sensors that assist in maintaining balance and detecting any potential issues related to gait or stability. These sensors help capture data related to movements, acceleration, gyration, and compass/magnetometer measurements through a 9-axis inertial measurement unit (IMU). This information allows for the determination of burned calories, fall detection, and provides valuable insights into the user's activity levels and overall mobility.
To enhance the functionality and usability, GPS technology is integrated into the insoles, enabling location determination. This feature can be particularly useful for tracking the whereabouts of loved ones or individuals with specific medical conditions that require constant monitoring or supervision.
The calculated data, such as accurate SmartSteps™ (including step type classification), accurate SmartCalories™, and other relevant health metrics, can be processed either through edge computing within the insoles themselves or at the mobile app level. This flexibility allows for real-time analysis and immediate feedback to the user, promoting proactive health management.
Data transmission is facilitated through Bluetooth® Low Energy (BLE) when LTE cellular connectivity is unavailable. When LTE cellular communication is accessible, the collected data is securely transmitted to a cloud platform for more sophisticated data analytics. This includes the utilization of artificial intelligence algorithms to derive meaningful insights and identify potential health issues or trends.
The cloud platform securely stores all collected data, allowing licensed medical professionals to remotely monitor their patients. They can access the data via smart apps or through phone calls, enabling timely communication and intervention to address any health concerns.
To ensure the privacy and security of sensitive health information, robust cybersecurity measures are implemented throughout the entire data transmission and storage process. This helps safeguard patient data, adhering to the stringent regulations and standards governing healthcare data protection.
In summary, smart RPM insoles with non-invasive optical sensors offer a holistic approach to remote patient monitoring in a HaH environment. By providing real-time, medical-grade accuracy measurements of vital signs, activity levels, and location determination, these insoles empower both patients and healthcare professionals to proactively manage health, enhance patient care, and potentially prevent adverse health events.
Health data includes sex, age, body weight, height, vital signs, and body movement data. Movement data can be simple step counts to more complex body center-of gravity "CoG" data for balance stabilization and fall detection and prevention software algorithms.
Health data is collected and stored in various ways, depending on the application. In some cases, the data is stored locally on a device or server, while in other cases, it may be stored in a centralized database called a data center and colloquially called the "cloud". It is important to ensure that a patient's health data is collected and stored securely, with appropriate encryption and access controls, to protect individuals' privacy and prevent unauthorized access (see "What is HIPAA?" below).
Hospital-at-Home (HaH) is a model of care that allows patients to receive acute care services in their homes instead of in a traditional hospital setting. HaH programs provide patients with access to a range of services, including skilled nursing care, intravenous medications, laboratory testing, and imaging services. The program is designed to provide patients with the same level of care as they would receive in a hospital but in the comfort of their own homes.
The HaH model is based on the premise that many patients can receive high-quality care in their homes and avoid the risks and stress associated with hospitalization. This model is particularly beneficial for patients with acute conditions who do not require complex interventions or surgery, such as patients with pneumonia, cellulitis, or heart failure.
HaH programs typically include a team of healthcare professionals, including a physician, nurse, and therapist, who work together to provide coordinated care to patients. The team communicates with the patient's primary care physician and other specialists as needed to ensure continuity of care.
HaH programs have been shown to reduce hospital readmissions, lower costs, and improve patient satisfaction. They also help to alleviate pressure on hospital resources by freeing up hospital beds for patients who require more complex care.
Overall, Hospital-at-Home is a promising model of care that has the potential to transform healthcare delivery by providing patients with high-quality care in the comfort of their own homes while reducing healthcare costs and improving outcomes.
Remote patient monitoring (RPM) is a healthcare technology that allows healthcare providers to monitor patients' health and wellness outside of traditional clinical settings. RPM technology typically uses digital devices, such as wearables, sensors, and mobile apps, to collect and transmit data on patients' vital signs, symptoms, and medication adherence.
RPM enables healthcare providers to monitor patients' health in real-time, allowing for earlier detection of changes in patients' conditions and more timely interventions. This technology is particularly useful for patients with chronic conditions, such as heart disease, chronic obstructive pulmonary disease (COPD) and diabetes, who require ongoing monitoring and care.
RPM can also reduce the need for in-person visits to healthcare providers, which can be particularly important for patients who live in remote areas or have limited mobility. By enabling patients to manage their conditions from home, RPM can improve patients' quality of life and reduce the burden of chronic disease management.
Some examples of RPM technology include blood glucose monitors for patients with diabetes, remote cardiac monitors for patients with heart disease, and mobile apps that track symptoms and medication adherence for patients with COPD.
Overall, RPM is a promising healthcare technology that has the potential to improve patients' health outcomes and reduce healthcare costs by enabling more effective and efficient care.
Digital therapeutics (DTx) refers to a subset of digital health technologies that use evidence-based interventions delivered via software programs, mobile apps, or other digital platforms to prevent, manage, or treat medical conditions. Unlike traditional medical treatments, which may rely on drugs or surgical interventions, DTx focuses on using digital tech to deliver therapeutic interventions.
Digital therapeutics may incorporate a range of techniques, such as cognitive behavioral therapy, mindfulness-based interventions, and biofeedback. These techniques can be delivered through a variety of digital channels, including wearable tech, mobile apps, virtual reality platforms, and other digital tools.
DTx is designed to be used in conjunction with traditional medical care and is often prescribed or recommended by healthcare providers. DTx interventions may be used to treat a variety of conditions, including chronic diseases (e.g., multiple sclerosis), mental health conditions, and substance abuse disorders.
DTx has the potential to improve patient outcomes by providing more personalized and accessible treatment options that can be delivered remotely, reducing the need for in-person visits to healthcare providers. It can also help to reduce healthcare costs by providing more cost-effective treatment options and improving patient adherence to treatment regimens.
DTx is an area of healthcare innovation that has the potential to transform the way we prevent, manage, and treat medical conditions.
Energy harvesting for wearable technology refers to the process of capturing and converting energy from the wearer's body or the environment to power the wearable device. This is particularly important for wearables, as they are typically small and require low power to operate, making traditional power sources impractical.
Some common forms of energy harvesting for wearables include:
Energy harvesting for wearable technology is important because it enables wearables to operate for longer periods without requiring frequent charging or battery replacements. This can improve the convenience and usability of wearables, and reduce the environmental impact of battery disposal. Additionally, it opens up new possibilities for wearables in applications where traditional power sources are impractical or impossible to use.
* Used by INVIZA to generate electrical energy.
Edge computing for wearables refers to the concept of processing and analyzing data on the device itself, rather than relying solely on a cloud platform. It involves performing computational tasks and running algorithms directly on the wearable device, closer to the point of data generation, instead of sending all the data to the cloud for processing.
Edge computing offers several advantages for wearables:
Artificial Intelligence is a Broad Term
Artificial Intelligence (AI) in wearables for digital health involves the utilization of techniques and technologies to enable devices and systems to exhibit intelligent behavior and perform tasks that require human-like intelligence. In this context, AI can encompass a range of approaches, including machine learning (ML), natural language processing, computer vision, expert systems, and more. AI aims to enhance the capabilities of wearable solutions by providing advanced functionalities such as personalized recommendations, intelligent decision-making, and context-aware analysis.
AI applications, which involve complex and resource-intensive algorithms, often benefit from the vast computing resources available in cloud platforms. Cloud-based AI solutions allow for scalability, parallel processing, and access to large datasets for training and inference. The cloud offers the necessary computational power, storage capacity, and infrastructure to handle the demanding computational requirements of AI.
On the other hand, ML algorithms are well-suited for deployment at the edge, such as on wearable devices (sometimes referred to as "Tiny ML" when applied at this scale or level). Edge computing brings the processing and analysis closer to the point of data generation, offering several advantages in the context of wearables and edge devices. ML models implemented at the edge can perform real-time data analysis, make quick decisions, and provide immediate responses without relying on cloud connectivity. Edge computing enables reduced latency, enhanced privacy and security, and optimized bandwidth by processing data locally on the device itself.
Machine Learning at the Wearable's Edge
By utilizing cloud platforms for AI and edge computing for ML, a complementary and distributed approach is achieved. The cloud handles computationally-intensive AI tasks like model training and large-scale data processing, while the edge handles real-time ML inference, data filtering, and immediate decision-making, bringing intelligence and autonomy to wearable devices and edge systems. Here are a few specific ways ML is applied in wearables:
To further elaborate on reducing power consumption, ML can enable predictive capabilities to anticipate future power demands. By analyzing historical data and considering contextual factors, ML models can predict power-intensive activities or events in advance. This allows the device to proactively optimize power allocation, ensuring sufficient energy is available during critical moments and avoiding unnecessary drain on the battery.
By employing ML at the edge, wearables can make intelligent and autonomous power management decisions, maximizing the utilization of energy from energy harvesters. This optimization leads to longer battery life between recharges, enhancing the overall usability and convenience of the wearable device for users.
PredictiveWellness™ monitoring, analytics and modeling for healthcare involve using data from various sources such as electronic health records and databases, patient monitoring devices, and medical imaging to predict patient outcomes and improve healthcare quality.
Our predictive AI models can be used to identify patients at risk of developing a particular disease or condition, predict the progression of a disease, determine the most effective treatment options for patients, and even be used to predict falls before they happen. These AI models can help healthcare providers make more informed decisions, optimize resources, and improve patient outcomes and safety.
For example, predictive AI models can be used to identify patients at risk of readmission to the hospital within 30 days of discharge. This can help healthcare providers take proactive measures to prevent readmissions, such as providing additional care or resources to at-risk patients. Reducing hospital readmission rates lowers healthcare costs, because 40-49% of U.S. hospitals are fined between $350M to $535M annually by the Centers of Medicare and Medicaid Services (CMS). This includes readmission of post-acute cardiac (e.g., heart attack and heart failure), respiratory (e.g., COPD and pneumonia), pulmonary (e.g., Coronary Artery Bypass Graft "CABG" surgery), and orthopedic (e.g., hip and knee replacement) patients being readmitted to the hospital within 30 days from discharge.
Another example is using predictive models to personalize treatment plans for patients based on their specific characteristics and medical history. This can improve treatment outcomes and reduce the risk of adverse events.
Big data analytics (BDA) for healthcare involves using advanced analytical techniques to extract insights from large and complex health datasets. The goal is to improve patient outcomes, reduce healthcare costs, and optimize hospital and HaH resource utilization.
The healthcare industry generates enormous amounts of data, from electronic health records (EHRs) and medical imaging to wearable devices and health monitoring systems. Big data analytics can help healthcare organizations make sense of this data, identify patterns, and gain valuable insights that can inform clinical decision-making, patient care, and public health interventions.
Here are some examples of how BDA is being used in healthcare:
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that required the creation of national standards to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge. The US Department of Health and Human Services (HHS) issued the HIPAA Privacy Rule to implement the requirements of HIPAA. The HIPAA Security Rule protects a subset of information covered by the Privacy.
HIPAA Privacy Rule
The Privacy Rule standards address the use and disclosure of individuals’ health information (known as Protected Health Information or PHI) by entities subject to the Privacy Rule. These individuals and organizations are called “covered entities.” The Privacy Rule also contains standards for individuals’ rights to understand and control how their health information is used. A major goal of the Privacy Rule is to make sure that individuals’ health information is properly protected while allowing the flow of health information needed to provide and promote high-quality healthcare, and to protect the public’s health and well-being. The Privacy Rule permits important uses of information while protecting the privacy of people who seek care and healing.
INVIZA® Health's revolutionary SmartPower ™ technology that converts steps into electricity is based upon world renown research on piezoelectric energy harvesting devices completed between The University of Vermont and the Cornell NanoScale Science and Technology Facility in a partnership with the Cornell Energy Materials Center with funding from the Army Research Laboratory (ARL), National Science Foundation / EPSCoR (NSF EPSCoR), New York State Foundation for Science, Technology, and Innovation (NYSTAR) and the New York Energy Research and Development Authority (NYSERDA).
One issued US patent and four applications are pending - 1st patent application published in January 2022 and our 2nd patent application has been allowed by the USPTO in 2024.
Five (5) patent applications and eight (8) provisional patent applications related to integrated wearables with sensors and energy harvesting technologies and metho
One issued US patent and four applications are pending - 1st patent application published in January 2022 and our 2nd patent application has been allowed by the USPTO in 2024.
Five (5) patent applications and eight (8) provisional patent applications related to integrated wearables with sensors and energy harvesting technologies and methods of manufacture have been filed. In addition, four (4) patent applications are in process with our patent agent and attorneys.
Our trademark, INVIZA® was registered in the USPTO in Dec 2021.
Our taglines, Powering Telehealth Connectivity™ and our service marks, PredictiveWellness™ monitoring, and SmartPower™ generation technology are in process.
Knowhow
Manufacturing both domestically and abroad, plus computer modeling and simulation. Building a successful startup company.
Trade Secrets
Significant energy harvesting manufacturing process secrets. Proven in-house developed analytical model to predict energy harvester energy/power output based on many materials used.
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