Tuesday, December 3, 2024

HEALTHTECH INTERNATIONAL FEATURE: INTRODUCING THE HEARTREADER™

INTRODUCTION
In October 12/13, 2024, HealthTech Reporter met with Dr. Sándor Kulin (developer of the HEARTREADER from Budapest, Hungary) at the Holistic Health Educational Expo in North Bergen, NJ. (see expo group). Dr. Kulin was part of an impressive lineup of unique health and medical speakers who presented (both in the venue and online) an array of important health topics and compelling lessons in health and longevity.  This educational event drew in crowds from every form of health disciplines including the conventional to functional, integrative to holistic and beyond.  

Photo by: Dr. Robert Bard
In this issue of HealthTech Reporter, we feature the concept behind of Dr. Kulin's innovation as a medical-grade scanning solution designed to generate reports and scores to support treatment response and estimating cardiovascular age. His HeartReader promotes the ability to generate reports and SCORES for physiological health such as Cardiovascular Health, Blood Pressure, Heart Fitness, Cardiac Stability and Autonomic Integrity.  The ultimate pursuit of the device was to mitigate the need to accurately identify these readings in support of monitoring heart health --for the detection of cardiovascular disorders, the leading cause of death globally. 

According to his interview in 11/22 Dr. Kulin, an integrative and holistic OB/GYN (obstetrician-gynecologist) originally founded this technology as a telemetry system for monitoring health levels for women under pregnancy as part of regular monitoring of their cardiac health called PregnaScan. Pregnancy involves profound physiological changes, including a remarkable 35% average increase in left ventricular mass. In a 2021 feature on HealthCare Outlook magazine, Dr. Kulin stated that after the launch of this first model- “...our aim is to serve even the non-medical entities with very reliable physiology data and help them improve their clients’ health. For example, trained fitness coaches and dietitians can analyze the  (recorded) parameters ...both the end-users and healthcare providers can easily deduce whether or not the prescribed advice is working for them".

Source: www.BardDiagnostics.com
MEDTECH EFFICACY CHALLENGE
Currently, the HTR publishing team and medical group is undergoing a series of performance testing sessions of the HeartReader™ in support of non-invasive health and medical solutions.  Dr. Robert Bard (of IHRC) & BardDiagnostics.com) spearheaded this TechReport project inspired by his commitment to explore innovations from the international health society.  

Additionally, in November of 2024, a collaborative  multi-modality program has been drafted to engage various heart rate variability and cardiovascular scanners to explore their strategies and data points, validating and confirming their effects as health screening technologies as part of HTR's SCAN & TREAT series.  "I am proud of the engineers, developers and medical conceptualists for their individual pursuits to advance the bar of personalized health and data gathering. SCREENING solutions in support of DIAGNOSTIC SCIENCE, especially in the realm of heart health is critically important in our medical community, offering an intelligent base line for a full array of testing. Meanwhile, as the pursuit for gold standards for 'Better Aging', prevention, early detection strategies wage on, these innovations (and the development leaders who promote them) hold a  powerful place in our international scientific, academic and medical communities as future luminaries", says Dr. Bard.


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Disclaimer:  HealthTech Reporter is an impartial technology news agency, and is not a marketing partner of our subjects featured in any way. Our supporters and affiliates do not confirm or endorse the material enclosed, including any data or submitted statements by individuals presented.  The following feature is written solely by Dr. Sandor Kulin, E-med4all Europe, Ltd. whereby all statements, concepts, technical reports, claims and visual representation about said product is published without any intent of marketing or commercial support  for its claims of the product's actual performance or efficacy.  Identified as a foreign device, HealthTech Reporter conditionally shares the contents of this feature as a strictly informational resource as part of our HTR "International Health Innovations".  This HealthTech segment is published with the full understanding of its status (as un-established) with US regulatory agencies, reflecting on its commercial access within the US medical device markets.


Bridging Science and Clinical Application: HeartReader’s Role By: Dr. Sándor Kulin

Source: HeartReader marketing

Peripheral pulse wave analysis is a well-established scientific method for evaluating an individual's hemodynamic status. However, transforming this methodology into a clinically applicable tool requires innovation and dedication. This is precisely the mission at HeartReader™: to develop and implement a robust system that bridges the gap between foundational research and practical healthcare applications.

HeartReader’s Core System and Scoring

HeartReader™ is built on more than 30 parameters derived from scientific literature, alongside a composite Total Score that provides an overall evaluation of cardiovascular health and risk levels. As noted by Professor Sengupta of Rutgers University, cardiovascular disorders remain the leading cause of death globally, emphasizing the urgent need for reliable tools to assess individual risk. Esteemed cardiologists and specialists acknowledge that HeartReader™ may be the first system to meet this critical need effectively.

In addition to the Total Score, HeartReader™ offers a series of specialized subscores, each targeting specific aspects of cardiovascular and overall health:

●    Cardiovascular Health Score
Assesses the aging speed of the arterial system and the heart, offering insights into vascular health over time.

●    Blood Pressure Score
Similar to HbA1c for blood sugar, this score identifies potential blood pressure issues over recent months rather than providing real-time measurements. A high score suggests lower cardiovascular risk, while a low score indicates potential concerns.

●    Heart Fitness Score
Evaluates physical capacity and cardiovascular exercise tolerance, reflecting an individual’s ability to endure physical activity.

●    Metabolic Fitness Score
Offers insights into cellular health, focusing on mitochondrial function. Through collaborations with experts in deutenomics (the study of deuterium content in mitochondria), we have increasing understanding how this score might be a potential indicator of mitochondrial health and energy production efficiency.

●    Cardiac Stability Score
Measures the likelihood of irregular heart rhythms or arrhythmias. A high score suggests stability, while a low score indicates potential risks.

●    Autonomic Integrity Score
Evaluates the overall activity and the balance between sympathetic and parasympathetic nervous system activity at the time of measurement, providing a snapshot of autonomic function.

Validated Insights from Real-World Data
While ongoing and planned clinical trials across Europe will further validate HeartReader, its current foundation is strong. Analysis of over 150,000 pulse wave recordings from more than 8,000 users confirms the system’s ability to translate traditional pulse wave parameters into clinically actionable insights.

Quick, Non-Invasive Measurements
All these insights are derived from a simple, non-invasive, two-minute measurement. HeartReader delivers a comprehensive evaluation that goes far beyond what is typically expected from such a straightforward process, empowering both clinicians and individuals to better understand and manage cardiovascular health.

HeartReader is at the forefront of innovation, providing healthcare professionals with reliable, personalized tools to assess and address cardiovascular and overall health effectively. The system collects data from a sensitive  HeartReader sensor connecting to a smartphone which is then sent to the cloud for real-time processing and storage.  (using the internet)


To make the data easy to interpret for both professionals and laypeople, the 30 parameters are summarized into a simplified metric called Scores. These scores not only reflect potential medical conditions but also provide valuable insights into the individual's overall health level.

Based on a database of 150,000 measurements, we developed the HeartReader Health Map™, which benchmarks health levels for individuals aged 15 to 85. This map assigns a health score on an absolute scale from 0 to 100, where higher numbers indicate better health. Additionally, it uses a relative scale, which compares an individual's health to others in the same age group, similar to percentile rankings in other medical assessments.

This dual-scale approach offers professionals a powerful diagnostic tool while also serving as an accessible screening resource for non-experts, providing a comprehensive understanding of an individual's health status.

Our long-term vision is to integrate HeartReader into medical practice as a prescription-based service. General practitioners, cardiologists, rehabilitation specialists, and obstetricians can invite their patients to use this advanced physiological monitoring and data collection system.

- To Be Continued -



SMARTER AGING: "RESETTING YOUR FUTURE"

By: Dr. Roberta Kline / Women's Health Digest

AGING is a natural process that is associated with biological changes that lead to a progressive decline in physiological functioning. Additionally, the risk of HEART DISEASE increases with age and irresponsibility where changes start as early as the mid-20's, accelerating in the mid-40's and again at around age 60. While aging is inevitable, the rate at which it occurs can be faster or slower depending on multiple factors, including the interactions of genetics with diet, lifestyle, environment, and stress. It is also impacted by resilience.

Without a doubt, everyone will experience aging. It’s a biological process that begins at birth, and it is inevitable. But how we age is not. We are redefining aging, celebrating it as a time of new opportunities, deeper connections, and ongoing learning. It’s a time where we are actively engaging life with joy and purpose.  Healthy aging is not just about keeping disease and disability at bay. While we’d all like to stay as healthy and functional as possible, we can age successfully and gracefully even with less-than-optimal  health. 

RESILIENCE is the ability to “bounce back” from an adverse event or experience, large or small. This is influenced by biological factors (including genetics) as well as psychological ones, and both forms of resilience can be cultivated. As people with higher levels of biological and psychological resilience tend to experience improved health and quality of life as they age, this heightens its importance for better aging.

Health is created from physical, emotional, mental, spiritual, and energetic balance. But balance is not static. It requires constant adjustment in response to changes and challenges in your inner and outer worlds - and often changes throughout your lifetime. Resilience helps you bounce back and regain balance.  Here are 8 simple strategies to help you cultivate resilience so you can handle whatever challenges come your way in a way that helps you thrive. (See complete report)




Continued: Introducing THE HEART READER


But how do obstetricians fit alongside specialists dealing with heart-related conditions? Pregnancy involves profound physiological changes, including a remarkable 40% average increase in left ventricular mass—greater than the changes seen in professional athletes after a year of intensive training. Maternal adaptation to these increased cardiovascular demands is essential for preventing pregnancy-related complications such as preeclampsia, gestational hypertension, and intrauterine growth restriction.

With daily monitoring through HeartReader, early signs of cardiovascular decompensation can be identified, enabling healthcare providers to intervene promptly and improve outcomes. HeartReader’s flexibility allows patients across all user groups to take measurements as often as recommended by their healthcare provider. The system’s ability to track hemodynamics and physiological trends over time provides critical insights, empowering clinicians to make informed decisions and deliver better care.


Practical Use of Data – Overview

Source: HeartReader marketing
Your blood sugar, blood pressure, and pulse rate each behave independently, and our analysis captures a range of values that can indicate areas of higher or lower health status. Over time, trends begin to emerge. By collecting data for at least two consecutive weeks, a clear average for key parameters can be established, providing a reliable baseline for assessing overall health. This allows us to offer more personalized and actionable advice to clients.

For physicians, this continuous data collection offers invaluable insights into how a patient’s physiology responds to prescribed medications, enabling more precise therapy adjustments and improved monitoring of medication adherence.

Currently, HeartReader is designed to become a prescription-based system ("RX"), primarily to support physicians in optimizing treatment regimens. However, its applications extend beyond traditional medical use. Lifestyle coaches, fitness trainers, and non-medical health counselors are increasingly utilizing the device to help their clients track health improvements and achieve longevity or lifestyle goals.

Given its versatility, the HeartReader system has the potential to expand into the over-the-counter (OTC) market, making it accessible to a broader audience for personal health tracking and long-term wellness management.


Personalized Testing & Validation for Launch

We have two published medical studies confirming the reliability and accuracy of the HeartReader system. These publications provide a solid foundation for the product's launch, showcasing its ability to deliver consistent and actionable insights into physiological health.


Study 1: Pulse Wave Morphology Analysis
The first study focused on the repeatability and accuracy of pulse morphology analysis. Our primary goal was to determine whether variations in measurements were due to device inaccuracy or the inherent dynamism of human physiology. To address this, we conducted tests using a pulse wave generator, a device that produces a consistent pulse wave regardless of timing or settings.

Results demonstrated that when the HeartReader receives the same input signal, its output remains consistent, proving the system’s high level of accuracy in capturing and analyzing data.












However, physiological variations were observed in real-world testing on individuals. These variations stem from the body's dynamic nature, influenced by factors as subtle as thoughts, consuming a cup of coffee, or taking a brief walk. This highlights a key insight: while HeartReader reliably tracks physiological changes, the dynamism of human physiology introduces natural variability. This contrasts with the "single-measurement" approach often used in conventional medical systems, which can overlook this dynamic nature.


Study 2: Heart Rate Variability (HRV) and Pulse Rate Variability (PRV) Analysis
The second publication examined the system's capability in heart rate variability (HRV) analysis, comparing it to the gold-standard software, Kubios, widely used for HRV research.

●     When the same input data was analyzed by both Kubios and HeartReader, the results showed a 99% agreement, affirming that HeartReader's HRV engine is as accurate as (or potentially even slightly more accurate than) Kubios.

●     Additionally, we compared ECG-based HRV with HeartReader's peripheral pulse-based pulse rate variability (PRV). The correlation between the two methods aligned closely with existing medical literature, further validating the system's precision and applicability.


Key Findings
These studies confirm that:

  1. Pulse Morphology Analysis is highly accurate and repeatable, reliably capturing physiological signals for preclinical use.
  2. HRV and PRV Analysis delivers results comparable to established gold-standard systems, making HeartReader a robust tool for understanding cardiovascular and autonomic nervous system dynamics.

HeartReader is not only accurate but also embraces the dynamic nature of human physiology, making it a revolutionary tool for personalized health monitoring and clinical support.  These studies pave the way forward towards the next steps to successfully integrate HeartReader into medical practice.

- To Be Continued -



PEDIATRIC MYOCARDITIS & NATIONAL DETECTION MOVEMENT
By: Dr. Robert L. Bard

Since the advent of Covid-19 Long Haul studies in 2021, the medical diagnostic community shifted into overdrive- seeking out all available screening and examination protocols to assess health problems called POST-ACUTE SEQUELAE (PASC). One of the recent Covid-19 related headliners is the rise in cases of MYOCARDITIS in children 16 years and under. CDC Reports link the pathological impact with covid infection since it is proven that Viral infections are a common cause of myocarditis. Between early 2020–2021, patients with Covid-19 had nearly 16 times the risk for myocarditis[1]. According to the CDC, in a study of myocarditis cases, 2,116 (41.7%) had a history of Covid-19.  In addition, cases of myocarditis reported to the Vaccine Adverse Event Reporting System (VAERS) indicated links between Myocarditis and Pericarditis to come from the mRNA Covid-19 vaccination (especially in male adolescents and young adults) more often after the second dose.[2].

Myocarditis is defined as an inflammatory disorder of the heart muscle (myocardium) leading to cardiac dysfunction. It is also recognized as myocardial cell death [3]. Checkups for this also reviews for PERICARDITIS (the inflammation of the outer lining of the heart). Various causes of myocarditis includes: Viral Infectious including adenoviruses, echoviruses, enteroviruses like the coxsackie viruses. In addition, predisposition can occur from those with Autoimmune diseases such as Celiac disease, Churg-Strauss syndrome, Crohn disease, Kawasaki disease, lupus, rheumatoid arthritis, sarcoidosis etc. (See NIH chart for full list of causes- [4])

STANDARDIZED DIAGNOSTICS
As with any critical disorder, detecting early stages of myocarditis allows for a higher opportunity to treat and even eliminate the health risk.  In children, symptoms include: Fever, Fainting, Breathing difficulties, Rapid breathing, Chest pain and Rapid or irregular heart rhythms [5]. In adults, symptoms range from chest pain, shortness of breath, at rest or during activity and fluid buildup with swelling of the legs, ankles and feet. To prevent possible heart damage, a cardiologist may order one of a number of imaging options:
▪ Electrocardiogram (ECG or EKG)
▪ Chest X-Ray
▪ Heart MRI
▪ Blood Tests
▪ Doppler Ultrasound for Acute Myocarditis
▪ Cardiovascular MR Elastography (MRE)
▪ Ultrasound Elastography

See expanded details on diagnostic protocols, visit:  http://pediatricscan.com/myocarditis.html





Continued: Introducing THE HEART READER

Evaluating System Performance in Clinical Contexts
The next critical question is: How does the HeartReader system perform under specific clinical conditions? While there is no universally accepted gold standard for peripheral pulse wave monitoring, our extensive dataset offers compelling insights into its reliability and clinical relevance.


Large-Scale Data Validation
With over 150,000 measurements collected from more than 8,000 individuals aged 15 to 85, our analysis revealed a strong correlation between many of the 30 calculated parameters and age. Since physiological and hemodynamic functions naturally evolve with age, this alignment with well-documented aging patterns serves as a robust internal validation of the system. The fact that HeartReader accurately reflects these age-related changes, recognized as "normal" by cardiologists and the broader medical community, reinforces the system’s credibility and precision.

Highlighting Individual Variability
In addition to reflecting typical aging trends, HeartReader uncovers individual differences in aging rates and cardiovascular health. Some individuals demonstrate faster or slower aging patterns, with corresponding variations in cardiovascular risks and conditions. This variability underscores the system's ability to go beyond averages and offer personalized insights. By identifying where a person falls relative to their age group, HeartReader provides a detailed picture of individual cardiovascular health, making it a powerful tool for early detection and intervention.

Establishing Age-Based Averages
Despite individual differences, the extensive data pool has enabled us to establish clear averages for each age group. These benchmarks further validate the system's capacity to serve as a precise and personalized monitoring tool, offering healthcare providers a reliable means of assessing cardiovascular health and guiding patient care.

HeartReader's combination of large-scale validation, individual variability analysis, and alignment with established medical norms positions it as a cutting-edge system for clinical and personalized health applications.

 

About the Author/Developer:

Dr. Sándor Kulin graduated as a medical doctor in 1990 at Semmelweis University, Budapest, and became an obstetrician and gynecologist at Imre Haynal University of Health Sciences in 1994.   He has special interest in maternal and fetal health, human physiology, cell physiology, hypoxia, malignant transformation, and therapy monitoring. Having almost 20 years of experience in non-invasive cardiovascular monitoring in 2018 he became a Co-founder and CEO of E-Med4All Europe Ltd, a Hungarian digital health startup, aiming to help the transformation towards a more data driven and personalized medicine and to be part of the shift of today’s medicine from disease management to prevention.


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