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Smart Clothing May Enable Cardiac Monitoring Without Electrodes

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iSmartweaR, smart clothing, jIndustrial Technology Research Institute, ITRI, wearable heart monitoring

An example of an iSmartweaR shirt that can monitor patient vital signs without the need for electrode wires.

October 24, 2016 — Conventional smart clothing uses conductive fibers or rubber as sensing electrodes, and cardiac electrical sensing modules have required at least two or more electrodes to contact the skin for capturing the heart’s electrophysiological signals. However, a new start up company is now offering smart textiles without the need for electrodes. 

iSmartweaR smart clothing, jointly developed by Industrial Technology Research Institute (ITRI) and ECLAT Textile Corp., transforms ordinary fabrics into smart wearables. It integrates nanosecond pulse near-field sensing technology (NPNS), with washable conductive fabrics allowing textile products to track vital signs without bodily contact. NPNS features miniature low-power radar utilizing Bluetooth transmission to connect with ICT systems. Its advantages are compact size, high sensitivity, high selectivity, high reliability, low price, low energy consumption, and penetrability.

ITRI’s smart clothing technology uses a single antenna radar sensing design that simultaneously detects human heartbeats, breathing rates and other activity levels all without causing any user discomfort, the manufacturer said. Utilizing low-power microwave technology, iSmartweaR does not have direct contact with the skin, so it does not cause direct pressure on the wearer’s body.

“iSmartweaR is significant and widely applicable,” said Hong-Dun Lin, manager of ITRI’s Center of Measurement Standards. “It can help prevent sudden death in infants by tracking their physiological parameters. It also analyzes a user’s average health data and can warn of abnormal fatigue levels. iSmartweaR can be used in individual sports training, long-term data analysis for senior citizen healthcare, and health monitoring for professionals such as police and firefighters. Therefore, not only is it practical for the general consumer but also for individuals in various professional fields.”

ITRI is a technology R&D institution focused on the fields of smart living, quality health and sustainable environment. It has incubated over 240 innovative companies

For more information: www.itri.org/eng


New Smartphone App Detects Heart Attacks

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smartphone application, heart attack detection, University of Turku Finland

October 28, 2016 — A smartphone application developed by researchers at the University of Turku, Finland, can detect myocardial infarction, commonly known as a heart attack. No extra equipment is required for the app as it utilizes the phone's built-in motion sensors, especially the gyroscope. Therefore, the used technology is largely similar to the app for detecting atrial fibrillation that the research group announced in August. The myocardial infarction detection app should be available for test use in 2017.

Cardiovascular diseases are the most common cause of death killing over 17.5 million people worldwide in 2012. One of the most well-known diseases belonging to this category is an acute myocardial infarction, i.e. a heart attack.

It is important to detect the heart attack when the first symptoms appear, so that the patient can receive medical care as quickly as possible. However, sometimes people mistakenly assume that the chest pain is transient or caused by a heart burn, which can be fatal.

Myocardial infarction is caused by a blockage in the coronary artery that supplies oxygen-rich blood to the heart. The part of the heart muscle suffering from the lack of oxygen can be permanently damaged and therefore urgent clinical intervention is very important. The best treatment is a quick coronary angioplasty, said Professor of Cardiology Juhani Airaksinen from the Heart Centre of Turku University Hospital.

The study tested how well a heart attack can be detected using only the data collected with the built-in motion sensors of a smartphone. The study group consisted of 17 infarction patients, who were treated at the Heart Centre of Turku University Hospital. Measurements were taken by placing the smartphone on a patient’s chest for a few minutes while they were laying down and it measured the rotational micromovements of the chest. One recording was taken from each patient during the heart attack and the other after the coronary angioplasty surgery. Next, the researchers compared the two datasets.

The sensors of the smartphone, such as the gyroscope, are so sensitive that they are able to measure the rotational micromovements of the chest caused by the movement of the heart when the phone is placed on the patient’s chest. When the blood flow to the heart muscle is disturbed, these micromovements in the chest are affected and the phone can sense it, said Project Manager Tero Koivisto from the Technology Research Center (TRC) at the University of Turku.

All iPhones and many Android phones feature a gyroscope. Data processing is carried out automatically and does not need to be interpreted by a person with medical training.

“Before the actual analysis that is based on machine learning, the data is preprocessed and, for example, the data corrupted by excessive movements is removed. After that, the machine learning algorithm we have developed can immediately tell if the patient is having a heart attack,” Koivisto said.

In the study, the algorithm detected myocardial infarction with the minimum accuracy of over 70 percent. The researchers believe that if the app has recorded the patient’s baseline before the heart attack, it should be possible to achieve an accuracy of over 90 percent.

When someone feels acute chest pain, the phone should be placed on their chest in order to start the recording. The data collection phase takes about two minutes. The app analyzes the data immediately and gives the result.

“The app is intended to encourage patients to seek medical care faster. Our goal is not to rule out heart attacks, but to give a signal to the patient when a real emergency is at hand,” Koivisto said of the intended use of the app.

“In my opinion, this is worth trying, because this kind of a solution could lower the threshold for seeking medical care in a case of acute myocardial infarction. Assessing the symptoms of a heart attack can be sometimes very difficult and the possible additional confirmation given by the app could be extremely necessary,” summarized Airaksinen.

The research results were achieved in a New Knowledge and Business from Research Ideas project funded by the Finnish Funding Agency for Innovation, Tekes.

The research results were published at the third European Congress on eCardiology & eHealth in Berlin, Oct. 26-28: Tero Koivisto, Olli Lahdenoja, Tero Hurnanen, Mojtaba Jafari Tadi, Eero Lehtonen, Tuija Vasankari, Antti Saraste, Tuomas Kiviniemi, Juhani Airaksinen, Mikko Pänkäälä, “Detecting indications of acute myocardial infarction using smartphone only solution”, European Congress on e-Cardiology & e-Health, 2016.

For more information: www.e-cardiohealth.com

Boston Scientific Announces Positive Results of HeartLogic Heart Failure Diagnostic Service Study

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Boston Scientific, HeartLogic Heart Failure Diagnostic Service, MultiSENSE trial data, AHA Scientific Sessions 2016

November 18, 2016 — Boston Scientific recently announced results from the first clinical trial evaluating the performance of the HeartLogic Heart Failure Diagnostic Service to predict impending heart failure (HF) decompensation. Data collected from the Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients (MultiSENSE) study were presented as a late-breaking clinical trial at the American Heart Association (AHA) Scientific Sessions 2016, Nov. 12-16 in New Orleans, and confirmed the HeartLogic alert provided a highly sensitive and timely predictor of a future HF event.

Data from the MultiSENSE trial demonstrated the HeartLogic alert had an observed sensitivity of 70 percent and a low unexplained alert rate (alerts not followed by a HF event) of 1.47 per patient per year. Additionally, the trial data demonstrated the HeartLogic alert could successfully notify clinicians of an associated HF event — defined as hospitalizations with HF as the primary diagnosis and HF outpatient treatment with intravenous therapy — with a 34-day median alert window.

"The primary endpoints were exceeded and demonstrated that this algorithm, which mimics the activity and analysis of a clinician by combining multiple measurements evaluating different aspects of heart physiology, is a strong predictor of heart failure events," said John P. Boehmer, M.D., principal investigator and medical director of the Heart Failure Program at The Pennsylvania State University College of Medicine and The Penn State Hershey Medical Center. "The study illustrates compelling performance of the HeartLogic algorithm for the detection of worsening heart failure and lays the foundation for future studies of the alert in clinical practice."

The study included 900 patients who had enhanced sensor data collection enabled in their cardiac resynchronization therapy defibrillator (CRT-D) systems and were followed for up to one year in either a development or test cohort. Information from the 500 patients within the development set was used to construct the HeartLogic composite index and alert algorithm by combining heart sounds, respiration rate and volume, thoracic impedance, heart rate and activity. The 400 patients within the test set were sequestered for subsequent independent validation of HeartLogic.

The company has submitted a design dossier for CE Mark and a premarket approval application for U.S. Food and Drug Administration approval of the HeartLogic service. Boston Scientific plans to conduct post-approval studies, including Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF), to further evaluate the alert.  

The HeartLogic Heart Failure Diagnostic Service is not currently available for use or sale.

For more information: www.bostonscientific.com

Smartphone Apps May Help Study Cardiovascular Health, Behaviors

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smartphone apps, cardiovascular health, Stanford University study, patient self-reporting, population health

January 4, 2017 — In a study published online by JAMA Cardiology, researchers from Stanford University assessed the feasibility of measuring physical activity, fitness and sleep from smartphones. The goal was to gain insight into activity patterns associated with life satisfaction and self-reported disease.

Studies have established the importance of physical activity, fitness, sleep and diet for cardiovascular health, yet these studies were completed with time-consuming, in-person measurements with substantial reliance on participant recall. Mobile technology, in particular advances in smartphone sensors, offers a new approach to the study of cardiovascular health and fitness. Direct measurement of activity through always-on, low-power motion chips provides a promising alternative to questionnaire-based approaches.

In 2015, Apple Inc. introduced an open-source framework to facilitate clinical research and standardization of data collection. One of the launch smartphone apps for the framework, MyHeart Counts, is a cardiovascular health study administered entirely via smartphone, incorporating direct sensor-based measurements of physical activity and fitness, as well as questionnaire assessment of sleep, lifestyle factors, risk perception and overall well-being.

From the launch to the time of the data freeze for this study (March to October 2015), the number of individuals (self-selected) who consented to participate was 48,968, representing all 50 states and the District of Columbia. Their median age was 36 years, and 82 percent were male. In total, 40,017 (82 percent of those who consented) uploaded data. Among those who consented, 42 percent completed four of the seven days of motion data collection, and 9 percent completed all seven days. Among those who consented, 82 percent filled out some portion of the questionnaires, and 10 percent completed the six-minute walk test, made available only at the end of seven days.

"Our study found five main results. First, we demonstrate the feasibility of consenting and engaging a large population across the United States using only smartphones. Second, we show that large-scale data can be gathered in real time from mobile devices, stored securely, transferred, deidentified and shared securely, including with participants. Third, we find that a data set for the six-minute walk test larger than any previously collected could be generated in weeks. Fourth, we report that state transition patterns of activity, not just absolute activity, relate to the reported presence of disease. Fifth, we conclude that there is a poor association between perceived and recorded physical activity, as well as perceived and formally estimated risk," the authors wrote.

"Most important, we also present the major challenges and limitations of mobile health research, including the skewed age and sex of participants, plus the rapid drop-off in engagement over time, with the resulting loss of data collection for several measures. To realize the promise of this novel approach to population health research, participant engagement needs to be optimized to maximize full participation of those who have expressed at least enough interest to download the app and consent to join the study."

"Large-scale, real-world assessment of physical activity, fitness and sleep using mobile devices may be a useful addition to future population health studies," the researchers concluded.

For more information: www.jamanetwork.com/journals/jamacardiology

BePATIENT

LindaCare Expands Remote Patient Monitoring Operations to the U.S.

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LindaCare, expansion, remote patient monitoring, CIEDs, cardiac implantable electronic devices, United States

January 18, 2017 — LindaCare announced that it will open a new customer support facility in Connecticut to support growing interest in their vendor-neutral software platform for monitoring patients with chronic heart disease and other conditions.

The announcement of the launch into the U.S. market follows substantial interest in LindaCare's solutions at the Heart Rhythm Society conference last year, the company said. The award of a $500,000 investment from Connecticut Innovations (CI) following success in their VentureClash investment challenge has allowed LindaCare to accelerate their plans to invest beyond their European base.

LindaCare’s first version of the product is a web-based software platform for the remote monitoring of patients with cardiac implantable electronic devices (CIEDs) and suffering from chronic heart failure (CHF) and cardiac arrhythmia; this accounts for an estimated total of about 10 million patients worldwide today.

The Connecticut office will initially comprise four sales and customer support professionals, with a planned rollout of further, localized support across the United States later in the year, bringing immediate access to high-quality support across multiple time zones.

In parallel, LindaCare is planning to provide Independent Diagnostic and Testing Facility (IDTF) patient monitoring services through accredited local service providers. These services will help to gather and analyze the remote data, thereby allowing busy medical professionals to focus on diagnosis and care of patients.

Miguel Maquieira, CTO and co-founder of LindaCare, indicated that a significant research and development phase is completing and the U.S. expansion will allow a new software suite and service model to be announced simultaneously in Europe and the U.S. in the next few weeks.

For more information: www.lindacare.com

BeVITAL

Wearable Monitor Allows Hospitals Improved Heart Failure Post-discharge Care

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Vital Connect, BePATIENT, BeVITAL remote monitoring system, HealthPatch MD

Vital Connect's HealthPatch MD wearable sensor, part of the BeVITAL remote monitoring system.

June 8, 2016 — Vital Connect Inc., developer of wearable biosensor technologies, and BePATIENT, a startup that develops patient-centric digital health solutions, announce the first North American deployment of BeVITAL. The remote patient monitoring solution combines VitalConnect’s U.S. Food and Drug Administration (FDA)-cleared biosensor, HealthPatch MD, with BePATIENT’s web-based solution and associated app, which allows the implementation of personalized healthcare programs accessible through mobile devices and computers.

This spring, BeVITAL will be used in a post-discharge heart failure patient monitoring study at John Muir Medical Center in Walnut Creek and Concord, Calif. Neal White, M.D., heart failure director at John Muir said, “We’re looking forward to seeing how sensor technology and connected patients combine to improve heart failure outcomes for our patients, including reduced readmissions.” The BeVITAL Solution will also be used to follow patients returning home after outpatient surgical procedures at Hospital Infantile De Las Californias in Tijuana, Mexico, in a study run by Scripps Translational Science Institute in San Diego.

The BeVITAL solution can be used to monitor and transmit eight FDA- and CE-cleared biometric data streams from HealthPatch MD directly to practitioners’ smartphones, tablets or computers. In addition, the BeVITAL Solution provides individualized care plans to patients along with meaningful insights to clinicians and researchers.

BeVITAL has already facilitated the post-discharge monitoring of over 80 surgical patients in clinical studies at five hospitals in Europe with two more deployments scheduled for this summer. Phillipe Topart, M.D., a surgeon from the Clinique de l’Anjou in France said, “BeVITAL appears to be a pioneering, innovative solution allowing us to meet the requirements of bariatric surgery follow-up. In general surgery, the vital signs monitoring HealthPatch MD along with the BePATIENT mobile app is a unique tool for remote patient monitoring and detecting post-operative complications. This solution represents a major support tool in complex ambulatory surgery. It seems to me that BeVITAL is a leading connected health solution.”

A patient-centric solution, BeVITAL has been positively received by patients. One patient reported, “The BeVITAL solution gave me the confidence I needed to leave the hospital earlier as I knew my medical team was remotely monitoring my health. It was really easy to use and help me understand what I needed to do after my surgery”.

For more information: www.bepatient.com


IDM100 integrated medical tablet

Dictum Health Initiates Telehealth Study for Neonate Cardiology

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Dictum Health, telehealth study, IDM100 tablet, neonate cardiology, in-home monitoring

July 19, 2016 — Dictum Health Inc. announced the launch of a post-U.S. Food and Drug Administration (FDA)-approval study of its end-to-end telehealth care-delivery system with University of California Davis Medical Center in Sacramento.

The study will demonstrate the effectiveness of Dictum Health’s end-to-end telehealth system, built upon its FDA-cleared, cyber-secure IDM100 integrated medical tablet. The tablet uses a HIPAA-compliant cloud and Care Central portal that enables a completely private Virtual Exam Room (VER) for in-home monitoring of high-risk infants. The neonatal cardiac care team will monitor the patients remotely and conduct examinations using VER. The goal is to improve clinical outcomes of children who have undergone surgery for single-ventricle hypoplastic left heart syndrome and are receiving post-surgical care at home.

Patients will use the VER to see a physician while simultaneously streaming real-time vital signs, cardiopulmonary data, medical images, analytics and trending information. Each of the 25 patients selected each year for the study will be assigned an IDM100 tablet upon hospital discharge for regular monitoring at home using live video and vital-signs management functions.

The study will evaluate how the VER’s live video streaming, vital-signs management and simultaneous real-time biometric data streaming through a secure, Web-enabled portal enhances home monitoring of at-risk infants. The study will also measure hospital readmission rates for these post-surgical patients and assess levels of acceptance of this technology by both providers and family caregivers.

For more information: www.dictumhealth.com

AirStrip One Web Client Receives U.S. Regulatory Clearance

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AirStrip One, ECG management, web client, U.S. clearance

October 11, 2016 — The U.S. Food and Drug Administration (FDA) has issued 510(K) Class II clearance to a web client for the AirStrip One mobile interoperability platform and application. The system can be run on desktops and laptops using Internet Explorer and Google Chrome.

AirStrip Chief Development Officer JF Lancelot said the AirStrip One web client is capable of displaying patient waveforms in near-real time, as well as alarms generated by bedside monitors.

AirStrip also recently received a U.S. patent for new functionality: ECG waveform ‘visual calipers’ within AirStrip One that allow clinicians to make measurements on digital waveforms, combine measurements, create waveform snippets and append documentation.

The information collected using AirStrip One with visual calipers can then be constructed into a single document or booklet to document more complex events, which can be exported into the electronic medical record (EMR). Structured data elements can also be sent into the EMR or a document management system.

Clinicians can quickly and accurately select the relevant ‘pre-, during and post-’ snippets during a complex cardiac event, supporting faster and more informed cardiac care decisions. Visual calipers can also be used to perform measurements without sending any information to an EMR.

ECGs are commonly taken for the diagnosis of various classes of patients, providing a host of information to analyze cardiovascular health, including potential cardiac disease and arrhythmia. Nurses and telemetry technicians currently carry the burden of documenting baseline ECGs for patients at every shift. Instead of having to physically cut and tape paper ECGs for placement in charts or scanning into the EMR, AirStrip ONE with visual snippets enables this task to be automated.

Lancelot said the visual calipers and snippets functions promise to have a substantial impact not only on tele-ICU (intensive care unit) and tele-CV (cardiovascular) services, but also on clinical workflows for alarm management. Time spent on documentation can be reduced and more precise information about the patient can be made available more quickly in the EMR. In addition, clinicians can reduce the time spent on non-clinical tasks such as finding, scanning, clipping and transporting paperwork.

AirStrip officials anticipate announcing the first customers to use AirStrip One with visual calipers in the near future. AirStrip was recently granted similar patents in Japan and Australia.

For more information: www.airstrip.com

Biotricity Expands Partnership with the University of Calgary on Wearable Monitors

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October 13, 2016 — Biotricity Inc. announced recently that it will be expanding its existing research partnership with the University of Calgary. In order to develop and validate the next generation of medically relevant wearable monitors, the focus of the new partnership will be on areas beyond cardiac medicine, including fetal monitoring and sleep apnea.

Biotricity’s goal is to develop a series of clinically accurate devices that are applicable in both clinical and home-based settings. The initial focus of this expanded partnership will be to investigate using heart rate variability monitoring (HRVM) to optimize recovery after surgery and medical illness, and to develop solutions for the fetal monitoring and sleep apnea markets as well.

David Liepert, Ph.D., a clinical assistant professor at the University of Calgary Cumming School of Medicine, anesthesiologist at AHS’ Rockyview General Hospital and lead investigator of the study added, “The Department of Anesthesia and Peri-Operative Medicine looks forward to expanding on the developmental heart rate variability monitoring  work we have already completed with the Bioflux device, and working with Biotricity's consumer-based Biolife device as well.”

He explained, “HRVM’s ability to simultaneously monitor internal physiology and activities of daily living combined with Biotricity’s convenience and portability seems ideal for tracking return-to-function and allowing early and individualized intervention and optimization. Maternal/fetal monitoring has long-included HRVM, and exploring the impact of offering convenience and portability to that patient group as well as the sleep apnea population is an exciting opportunity. We look forward to capitalizing on [Biotricity CEO and founder] Waqaas Al-Siddiq's expertise in wearable biometric monitoring, connectivity and data processing and are also exploring the benefits of creating a relationship with the University of Calgary's Schulich School of Engineering which would be of utmost value to Alberta's budding Biomedical Engineers."

In other news, Biotricity is expecting a response from the U.S. Food and Drug Administration (FDA) to their 510(k) submission within the next few weeks.

For more information: www.biotricity.com

Smart Clothing May Enable Cardiac Monitoring Without Electrodes

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iSmartweaR, smart clothing, jIndustrial Technology Research Institute, ITRI, wearable heart monitoring

An example of an iSmartweaR shirt that can monitor patient vital signs without the need for electrode wires.

October 24, 2016 — Conventional smart clothing uses conductive fibers or rubber as sensing electrodes, and cardiac electrical sensing modules have required at least two or more electrodes to contact the skin for capturing the heart’s electrophysiological signals. However, a new start up company is now offering smart textiles without the need for electrodes. 

iSmartweaR smart clothing, jointly developed by Industrial Technology Research Institute (ITRI) and ECLAT Textile Corp., transforms ordinary fabrics into smart wearables. It integrates nanosecond pulse near-field sensing technology (NPNS), with washable conductive fabrics allowing textile products to track vital signs without bodily contact. NPNS features miniature low-power radar utilizing Bluetooth transmission to connect with ICT systems. Its advantages are compact size, high sensitivity, high selectivity, high reliability, low price, low energy consumption, and penetrability.

ITRI’s smart clothing technology uses a single antenna radar sensing design that simultaneously detects human heartbeats, breathing rates and other activity levels all without causing any user discomfort, the manufacturer said. Utilizing low-power microwave technology, iSmartweaR does not have direct contact with the skin, so it does not cause direct pressure on the wearer’s body.

“iSmartweaR is significant and widely applicable,” said Hong-Dun Lin, manager of ITRI’s Center of Measurement Standards. “It can help prevent sudden death in infants by tracking their physiological parameters. It also analyzes a user’s average health data and can warn of abnormal fatigue levels. iSmartweaR can be used in individual sports training, long-term data analysis for senior citizen healthcare, and health monitoring for professionals such as police and firefighters. Therefore, not only is it practical for the general consumer but also for individuals in various professional fields.”

ITRI is a technology R&D institution focused on the fields of smart living, quality health and sustainable environment. It has incubated over 240 innovative companies

For more information: www.itri.org/eng

New Smartphone App Detects Heart Attacks

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smartphone application, heart attack detection, University of Turku Finland

October 28, 2016 — A smartphone application developed by researchers at the University of Turku, Finland, can detect myocardial infarction, commonly known as a heart attack. No extra equipment is required for the app as it utilizes the phone's built-in motion sensors, especially the gyroscope. Therefore, the used technology is largely similar to the app for detecting atrial fibrillation that the research group announced in August. The myocardial infarction detection app should be available for test use in 2017.

Cardiovascular diseases are the most common cause of death killing over 17.5 million people worldwide in 2012. One of the most well-known diseases belonging to this category is an acute myocardial infarction, i.e. a heart attack.

It is important to detect the heart attack when the first symptoms appear, so that the patient can receive medical care as quickly as possible. However, sometimes people mistakenly assume that the chest pain is transient or caused by a heart burn, which can be fatal.

Myocardial infarction is caused by a blockage in the coronary artery that supplies oxygen-rich blood to the heart. The part of the heart muscle suffering from the lack of oxygen can be permanently damaged and therefore urgent clinical intervention is very important. The best treatment is a quick coronary angioplasty, said Professor of Cardiology Juhani Airaksinen from the Heart Centre of Turku University Hospital.

The study tested how well a heart attack can be detected using only the data collected with the built-in motion sensors of a smartphone. The study group consisted of 17 infarction patients, who were treated at the Heart Centre of Turku University Hospital. Measurements were taken by placing the smartphone on a patient’s chest for a few minutes while they were laying down and it measured the rotational micromovements of the chest. One recording was taken from each patient during the heart attack and the other after the coronary angioplasty surgery. Next, the researchers compared the two datasets.

The sensors of the smartphone, such as the gyroscope, are so sensitive that they are able to measure the rotational micromovements of the chest caused by the movement of the heart when the phone is placed on the patient’s chest. When the blood flow to the heart muscle is disturbed, these micromovements in the chest are affected and the phone can sense it, said Project Manager Tero Koivisto from the Technology Research Center (TRC) at the University of Turku.

All iPhones and many Android phones feature a gyroscope. Data processing is carried out automatically and does not need to be interpreted by a person with medical training.

“Before the actual analysis that is based on machine learning, the data is preprocessed and, for example, the data corrupted by excessive movements is removed. After that, the machine learning algorithm we have developed can immediately tell if the patient is having a heart attack,” Koivisto said.

In the study, the algorithm detected myocardial infarction with the minimum accuracy of over 70 percent. The researchers believe that if the app has recorded the patient’s baseline before the heart attack, it should be possible to achieve an accuracy of over 90 percent.

When someone feels acute chest pain, the phone should be placed on their chest in order to start the recording. The data collection phase takes about two minutes. The app analyzes the data immediately and gives the result.

“The app is intended to encourage patients to seek medical care faster. Our goal is not to rule out heart attacks, but to give a signal to the patient when a real emergency is at hand,” Koivisto said of the intended use of the app.

“In my opinion, this is worth trying, because this kind of a solution could lower the threshold for seeking medical care in a case of acute myocardial infarction. Assessing the symptoms of a heart attack can be sometimes very difficult and the possible additional confirmation given by the app could be extremely necessary,” summarized Airaksinen.

The research results were achieved in a New Knowledge and Business from Research Ideas project funded by the Finnish Funding Agency for Innovation, Tekes.

The research results were published at the third European Congress on eCardiology & eHealth in Berlin, Oct. 26-28: Tero Koivisto, Olli Lahdenoja, Tero Hurnanen, Mojtaba Jafari Tadi, Eero Lehtonen, Tuija Vasankari, Antti Saraste, Tuomas Kiviniemi, Juhani Airaksinen, Mikko Pänkäälä, “Detecting indications of acute myocardial infarction using smartphone only solution”, European Congress on e-Cardiology & e-Health, 2016.

For more information: www.e-cardiohealth.com

LindaCare Expands Remote Patient Monitoring Operations to the U.S.

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LindaCare, expansion, remote patient monitoring, CIEDs, cardiac implantable electronic devices, United States

January 18, 2017 — LindaCare announced that it will open a new customer support facility in Connecticut to support growing interest in their vendor-neutral software platform for monitoring patients with chronic heart disease and other conditions.

The announcement of the launch into the U.S. market follows substantial interest in LindaCare's solutions at the Heart Rhythm Society conference last year, the company said. The award of a $500,000 investment from Connecticut Innovations (CI) following success in their VentureClash investment challenge has allowed LindaCare to accelerate their plans to invest beyond their European base.

LindaCare’s first version of the product is a web-based software platform for the remote monitoring of patients with cardiac implantable electronic devices (CIEDs) and suffering from chronic heart failure (CHF) and cardiac arrhythmia; this accounts for an estimated total of about 10 million patients worldwide today.

The Connecticut office will initially comprise four sales and customer support professionals, with a planned rollout of further, localized support across the United States later in the year, bringing immediate access to high-quality support across multiple time zones.

In parallel, LindaCare is planning to provide Independent Diagnostic and Testing Facility (IDTF) patient monitoring services through accredited local service providers. These services will help to gather and analyze the remote data, thereby allowing busy medical professionals to focus on diagnosis and care of patients.

Miguel Maquieira, CTO and co-founder of LindaCare, indicated that a significant research and development phase is completing and the U.S. expansion will allow a new software suite and service model to be announced simultaneously in Europe and the U.S. in the next few weeks.

For more information: www.lindacare.com


Biotronik Initiates BioInsight Study of BioMonitor 2 Cardiac Monitor

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Biotronik, BioMonitor 2 implantable cardiac monitor, BioInsight clinical study, first patients enrolled

January 20, 2017 — Biotronik has enrolled the first patients in the BioInsight clinical study evaluating the safety and feasibility of performing the minimally invasive BioMonitor 2 insertion procedure in an office setting.

BioMonitor 2 is an insertable cardiac remote monitor with ProMRI technology that is placed underneath a patient's skin to help physicians accurately detect and diagnose atrial fibrillation and syncope (fainting). Atrial fibrillation is a leading cause of stroke and heart failure. BioMonitor 2 provides the highest signal amplitude on the market, according to Biotronik, which leads to excellent sensitivity for improved reporting accuracy. The device can also be used to monitor atrial fibrillation in patients who have undergone ablation procedures. More than 2,000 BioMonitor 2 devices have been sold in the United States since U.S. Food and Drug Administration (FDA) approval in April 2016.

"One of the benefits of BioMonitor 2 is the ease of the insertion procedure, which typically only takes a few minutes," commented Raul Weiss, M.D., cardiologist at Ohio State University. "In-office procedures can reduce patient's and physician's time, increase access to the device and reduce cost burdens for healthcare systems. Early insertion will likely also reduce the time needed for a conclusive diagnosis."

The BioInsight study is a multi-center, prospective, non-randomized post-market study. Participants will receive Biotronik's BioMonitor 2 via in-office insertion and will be evaluated for 90 days to monitor for any potential adverse events, including infection and bleeding.

The BioInsight study is expected to be completed in the third quarter of 2017.

For more information: www.biotronik.com

Boston Scientific Announces Positive Results of HeartLogic Heart Failure Diagnostic Service Study

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Boston Scientific, HeartLogic Heart Failure Diagnostic Service, MultiSENSE trial data, AHA Scientific Sessions 2016

November 18, 2016 — Boston Scientific recently announced results from the first clinical trial evaluating the performance of the HeartLogic Heart Failure Diagnostic Service to predict impending heart failure (HF) decompensation. Data collected from the Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients (MultiSENSE) study were presented as a late-breaking clinical trial at the American Heart Association (AHA) Scientific Sessions 2016, Nov. 12-16 in New Orleans, and confirmed the HeartLogic alert provided a highly sensitive and timely predictor of a future HF event.

Data from the MultiSENSE trial demonstrated the HeartLogic alert had an observed sensitivity of 70 percent and a low unexplained alert rate (alerts not followed by a HF event) of 1.47 per patient per year. Additionally, the trial data demonstrated the HeartLogic alert could successfully notify clinicians of an associated HF event — defined as hospitalizations with HF as the primary diagnosis and HF outpatient treatment with intravenous therapy — with a 34-day median alert window.

"The primary endpoints were exceeded and demonstrated that this algorithm, which mimics the activity and analysis of a clinician by combining multiple measurements evaluating different aspects of heart physiology, is a strong predictor of heart failure events," said John P. Boehmer, M.D., principal investigator and medical director of the Heart Failure Program at The Pennsylvania State University College of Medicine and The Penn State Hershey Medical Center. "The study illustrates compelling performance of the HeartLogic algorithm for the detection of worsening heart failure and lays the foundation for future studies of the alert in clinical practice."

The study included 900 patients who had enhanced sensor data collection enabled in their cardiac resynchronization therapy defibrillator (CRT-D) systems and were followed for up to one year in either a development or test cohort. Information from the 500 patients within the development set was used to construct the HeartLogic composite index and alert algorithm by combining heart sounds, respiration rate and volume, thoracic impedance, heart rate and activity. The 400 patients within the test set were sequestered for subsequent independent validation of HeartLogic.

The company has submitted a design dossier for CE Mark and a premarket approval application for U.S. Food and Drug Administration approval of the HeartLogic service. Boston Scientific plans to conduct post-approval studies, including Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF), to further evaluate the alert.  

The HeartLogic Heart Failure Diagnostic Service is not currently available for use or sale.

For more information: www.bostonscientific.com

Smartphone Apps May Help Study Cardiovascular Health, Behaviors

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smartphone apps, cardiovascular health, Stanford University study, patient self-reporting, population health

January 4, 2017 — In a study published online by JAMA Cardiology, researchers from Stanford University assessed the feasibility of measuring physical activity, fitness and sleep from smartphones. The goal was to gain insight into activity patterns associated with life satisfaction and self-reported disease.1

Studies have established the importance of physical activity, fitness, sleep and diet for cardiovascular health, yet these studies were completed with time-consuming, in-person measurements with substantial reliance on participant recall. Mobile technology, in particular advances in smartphone sensors, offers a new approach to the study of cardiovascular health and fitness. Direct measurement of activity through always-on, low-power motion chips provides a promising alternative to questionnaire-based approaches.

In 2015, Apple Inc. introduced an open-source framework to facilitate clinical research and standardization of data collection. One of the launch smartphone apps for the framework, MyHeart Counts, is a cardiovascular health study administered entirely via smartphone, incorporating direct sensor-based measurements of physical activity and fitness, as well as questionnaire assessment of sleep, lifestyle factors, risk perception and overall well-being.

From the launch to the time of the data freeze for this study (March to October 2015), the number of individuals (self-selected) who consented to participate was 48,968, representing all 50 states and the District of Columbia. Their median age was 36 years, and 82 percent were male. In total, 40,017 (82 percent of those who consented) uploaded data. Among those who consented, 42 percent completed four of the seven days of motion data collection, and 9 percent completed all seven days. Among those who consented, 82 percent filled out some portion of the questionnaires, and 10 percent completed the six-minute walk test, made available only at the end of seven days.

"Our study found five main results. First, we demonstrate the feasibility of consenting and engaging a large population across the United States using only smartphones. Second, we show that large-scale data can be gathered in real time from mobile devices, stored securely, transferred, deidentified and shared securely, including with participants. Third, we find that a data set for the six-minute walk test larger than any previously collected could be generated in weeks. Fourth, we report that state transition patterns of activity, not just absolute activity, relate to the reported presence of disease. Fifth, we conclude that there is a poor association between perceived and recorded physical activity, as well as perceived and formally estimated risk," the authors wrote.

"Most important, we also present the major challenges and limitations of mobile health research, including the skewed age and sex of participants, plus the rapid drop-off in engagement over time, with the resulting loss of data collection for several measures. To realize the promise of this novel approach to population health research, participant engagement needs to be optimized to maximize full participation of those who have expressed at least enough interest to download the app and consent to join the study."

"Large-scale, real-world assessment of physical activity, fitness and sleep using mobile devices may be a useful addition to future population health studies," the researchers concluded.

Read the article "How Smartphones and Apps May Change the Face of Healthcare."

For more information: www.jamanetwork.com/journals/jamacardiology

References

1. McConnell, M.V., Shcherbina, A., Pavlovic, A., et al. "Feasibility of Obtaining Measures of Lifestyle From a Smartphone App: The MyHeart Counts Cardiovascular Health Study,"JAMA Cardiology. Published online Dec. 14, 2016. doi:10.1001/jamacardio.2016.4395

LindaCare Expands Remote Patient Monitoring Operations to the U.S.

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LindaCare, expansion, remote patient monitoring, CIEDs, cardiac implantable electronic devices, United States

January 18, 2017 — LindaCare announced that it will open a new customer support facility in Connecticut to support growing interest in their vendor-neutral software platform for monitoring patients with chronic heart disease and other conditions.

The announcement of the launch into the U.S. market follows substantial interest in LindaCare's solutions at the Heart Rhythm Society conference last year, the company said. The award of a $500,000 investment from Connecticut Innovations (CI) following success in their VentureClash investment challenge has allowed LindaCare to accelerate their plans to invest beyond their European base.

LindaCare’s first version of the product is a web-based software platform for the remote monitoring of patients with cardiac implantable electronic devices (CIEDs) and suffering from chronic heart failure (CHF) and cardiac arrhythmia; this accounts for an estimated total of about 10 million patients worldwide today.

The Connecticut office will initially comprise four sales and customer support professionals, with a planned rollout of further, localized support across the United States later in the year, bringing immediate access to high-quality support across multiple time zones.

In parallel, LindaCare is planning to provide Independent Diagnostic and Testing Facility (IDTF) patient monitoring services through accredited local service providers. These services will help to gather and analyze the remote data, thereby allowing busy medical professionals to focus on diagnosis and care of patients.

Miguel Maquieira, CTO and co-founder of LindaCare, indicated that a significant research and development phase is completing and the U.S. expansion will allow a new software suite and service model to be announced simultaneously in Europe and the U.S. in the next few weeks.

For more information: www.lindacare.com

Biotronik Initiates BioInsight Study of BioMonitor 2 Cardiac Monitor

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Biotronik, BioMonitor 2 implantable cardiac monitor, BioInsight clinical study, first patients enrolled

January 20, 2017 — Biotronik has enrolled the first patients in the BioInsight clinical study evaluating the safety and feasibility of performing the minimally invasive BioMonitor 2 insertion procedure in an office setting.

BioMonitor 2 is an insertable cardiac remote monitor with ProMRI technology that is placed underneath a patient's skin to help physicians accurately detect and diagnose atrial fibrillation and syncope (fainting). Atrial fibrillation is a leading cause of stroke and heart failure. BioMonitor 2 provides the highest signal amplitude on the market, according to Biotronik, which leads to excellent sensitivity for improved reporting accuracy. The device can also be used to monitor atrial fibrillation in patients who have undergone ablation procedures. More than 2,000 BioMonitor 2 devices have been sold in the United States since U.S. Food and Drug Administration (FDA) approval in April 2016.

"One of the benefits of BioMonitor 2 is the ease of the insertion procedure, which typically only takes a few minutes," commented Raul Weiss, M.D., cardiologist at Ohio State University. "In-office procedures can reduce patient's and physician's time, increase access to the device and reduce cost burdens for healthcare systems. Early insertion will likely also reduce the time needed for a conclusive diagnosis."

The BioInsight study is a multi-center, prospective, non-randomized post-market study. Participants will receive Biotronik's BioMonitor 2 via in-office insertion and will be evaluated for 90 days to monitor for any potential adverse events, including infection and bleeding.

The BioInsight study is expected to be completed in the third quarter of 2017.

For more information: www.biotronik.com

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