March 29, 2018 — Abbott announced the company has initiated the landmark GUIDE-HF clinical trial using the CardioMEMS HF System. The GUIDE-HF trial will study whether the CardioMEMS device can improve survival and quality of life for people living with New York Heart Association (NYHA) Class II - IV heart failure.

The system has already been proven, when managed by a physician, to significantly reduce heart failure hospital admissions and improve the quality of life for people living with NYHA Class III heart failure. Doctors use the NYHA classification system to classify heart failure according to the severity of a person's symptoms.

"Monitoring pulmonary artery pressure with Abbott's CardioMEMS device has already been shown to offer improvements in patient care. We now want to build a stronger body of clinical evidence, with GUIDE-HF, that establishes its role in improving patient survival," said JoAnn Lindenfeld, M.D., primary investigator for the GUIDE-HF trial and director of advanced heart failure at Vanderbilt University Medical Center in Nashville.

The prospective trial will enroll 3,600 patients at 140 hospitals across North America with stage C, NYHA Class II-IV heart failure with either elevated brain-type natriuretic peptide (BNP) levels or prior heart failure hospitalizations in the past 12 months.

First implants for the trial occurred recently at:

• Providence Hospital, Southfield, Mich., by Marcel Zughaib, M.D., and Herman Kado, M.D.;
• Sanford Medical Center, Sioux Falls, S.D., by Orvar Jonsson, M.D.; and
• Austin Heart, Austin, Texas by Kunjan Bhatt, M.D.

The GUIDE-HF trial is designed to build on the clinical experience gained from the CHAMPION trial and aims to provide additional clinical evidence to further expand coverage for this first-of-its-kind technology.

For people living with heart failure, changes in the pressure of blood through the pulmonary artery can indicate worsening heart failure — even before symptoms such as shortness of breath or weight gain are reported. Abbott's CardioMEMS HF System allows physicians to remotely monitor pressure changes before the patient's symptoms progress. This personalized approach allows physicians to more proactively manage a patient's care while reducing the likelihood of hospitalization.

The CardioMEMS HF System features a small pressure-sensing device, no larger than the size of a small paperclip, that is implanted through a minimally invasive procedure, directly into the patient's pulmonary artery. While at home, patients lay on a special pillow to wirelessly take a pressure reading. Data from the sensor is collected through radio frequency to the pillow's antenna and then is sent wirelessly to the patient's doctor. This information can then be used by physicians to proactively adjust medications and treatment plans, if needed.

For more information: www.sjm.com

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May 16, 2018 — Itamar Medical Ltd. announced the launch of SleePath, the first integrated e-health sleep apnea care pathway monitoring system to monitor atrial fibrillation (AF) patients’ sleep apnea management status and compliance with continuous positive airway pressure (CPAP) devices on demand.

Effective management of sleep apnea is essential for improving outcomes in patients with AF, a type of irregular heartbeat that affects 6 million individuals in the United States. SleePath was unveiled at Heart Rhythm 2018, the annual meeting of the Heart Rhythm Society, May 9-12 in Boston.

Sleep apnea occurs in roughly 50 percent of patients with AF; it is found in a higher proportion of AF patients scheduled for catheter ablation, a minimally invasive procedure commonly used to treat AF, which eliminates the cells that give rise to irregular heartbeat. In AF patients with sleep apnea, catheter ablation is most effective when used in conjunction with adherence to a CPAP regimen.

“Effective management of sleep apnea is now believed to be critical for controlling atrial fibrillation post-ablation. The ability for us, the electrophysiologists, to assess patients’ sleep apnea status and their adherence to CPAP on demand and correlating it to the AF manifestations is a big help,” said Elad Anter, M.D., of Beth Israel Deaconess in Boston. “The information that SleePath provides is important for achieving optimal outcomes following catheter ablation. Knowing that a patient isn’t using their CPAP as prescribed is an important first step in opening a dialog with the sleep experts that can identify obstacles and help improve adherence.”

Utilizing data from the Philips Respironics CPAP machines, SleePath includes a Cardio Sleep Dashboard that allows physicians to track multiple aspects of a patient’s sleep apnea status anytime and anyplace. The system monitors care pathway progress, diagnosis status and results, CPAP compliance, the number of days and hours on CPAP, and residual sleep apnea. Data are presented in a user-friendly visual format that makes it easy to see progress or deviation toward specific treatment goals and changes in metrics over time.

For more information: www.itamar-medical.com

May 17, 2018 — A new study published in JAMA Cardiology used the Zio continuous cardiac monitoring system by iRhythm to provide a comprehensive picture of the burden of atrial fibrillation (AF) in patients. Utilizing this data in combination with electronic health record data, the researchers concluded that an increase in AF burden is independently associated with a higher risk of ischemic stroke and arterial thromboembolism in patients who are not taking anticoagulant medication.

The Kaiser Permanente Real-World Heart Monitoring Strategy Evaluation Treatment Patterns and Health Metrics in Atrial Fibrillation (KP-RHYTHM) study derived its findings from a retrospective cohort of 1,965 patients at two large integrated healthcare delivery systems. All patients underwent up to 14 days of continuous ambulatory electrocardiogram (ECG) monitoring using Zio by iRhythm and were found to have paroxysmal (intermittent) AF. By using Zio by iRhythm to measure heart rhythm, the researchers were able to overcome limitations of previous studies that only looked at patients undergoing cardiac monitoring via invasive and expensive devices.

True AF burden, as detected and measured by the Zio Service, gives physicians a comprehensive understanding of the amount of time a patient’s heart spends in AF over the extended monitoring period. This is achieved through Zio’s longer wear time and ability to bridge AF episodes that may be separated by noise or artifact. The results of the study show that the total burden of AF was the key indicating factor for stroke risk, as opposed to longer individual AF episodes with smaller overall burden. The results show that an AF burden lasting more than 11 percent of the total time their heart rhythm was monitored was found to be associated with a three-fold increase in stroke risk, independent of other known risk factors in those patients.

“There is an emerging recognition of the importance of AF burden as a potentially better measure of stroke risk, which is underscored by the recent AHA Scientific Statement ‘Atrial Fibrillation Burden: Moving Beyond Atrial Fibrillation as a Binary Entity’,” said Elsayed Z. Soliman, M.D., professor and director, Epidemiological Cardiology Research Center, Wake Forest University School of Medicine, Winston Salem, N.C. “Studies like the KP-RHYTHM study demonstrate how advances in cardiac monitoring technology enhance our understanding of AF burden, which could help improve the current standards of care and improve patient outcomes.”

Strokes associated with AF tend to be more severe and are associated with higher mortality. By providing a deeper understanding of the link between burden of AF with risk of stroke, this study can have a direct impact on clinical decision making to prevent stroke, as it provides another stroke risk indicator that physicians can evaluate and share with their patients while discussing stroke prevention.

The research was led by Alan Go, M.D., chief, cardiovascular and metabolic conditions research at Kaiser Permanente.

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

May 23, 2018 — Medtronic announced on May 23, 2018 that it will discontinue marketing for its SEEQ Mobile Cardiac Telemetry (MCT) System to concentrate support on its Reveal LINQ Insertable Cardiac Monitor (ICM) System.

The announcement said Medtronic will continue to service patients who are currently using SEEQ MCT, and that providers may place online orders for new SEEQ patient prescriptions through May 25, 2018. The company said this timeline would allow it to provide monitoring and related services for the duration of the prescriptions.

SEEQ MCT patient data and reports will be available to download via SEEQ Online Reporting through Aug. 31, 2018. Beyond this date, Medtronic will be able to pull and send SEEQ MCT patient reports by customer request.

Launched in the U.S. in 2014, the SEEQ MCT System was designed to be worn for up to 30 days to help detect and diagnose the cause of irregular heartbeats. Medtronic acquired the technology from Corventis Inc., which developed the technology. Automatically activated when applied to the skin, the SEEQ MCT System includes a wearable sensor that monitors the heart continuously for up to 30 days. With a slim profile and no wires (about 15mm or 0.6 inches in depth), the adhesive sensor can be worn discreetly under clothing and is water-resistant so that patients can be monitored continuously while exercising, showering or sleeping.

The SEEQ MCT System remotely monitors every heartbeat and automatically sends important cardiac data to the Medtronic Monitoring Center. While the SEEQ MCT System captures and transmits cardiac data automatically, a trigger button also allows patients to alert the monitoring center, should they have symptoms. Whichever way the trigger is activated, data are transmitted via Bluetooth and cellular connections to the Monitoring Center, which provides reports to prescribing physicians for review and analysis.

The system is indicated for patients who experience symptoms that suggest an irregular heartbeat such as syncope (fainting), lightheadedness, vertigo, palpitations or shortness of breath, and whose symptoms were not detected by a 24-hour Holter monitor.

While the SEEQ MCT System is prescribed for patients who may require up to 30 days of monitoring, Medtronic also introduced the Reveal LINQ Insertable Cardiac Monitoring (ICM) System in 2014, which can continuously monitor patients for up to three years. The Reveal LINQ ICM is designed for patients whose cardiac arrhythmias are less frequent and may not be detected by short-term monitoring systems.

For more information: www.medtronic.com

June 5, 2018 — The future of cardiovascular care will be transformed by advances in artificial intelligence, digital health technology and mobile devices as a means to prevent and treat heart disease, according to several articles published June 4, 2018 in a Journal of the American College of Cardiology Focus Seminar on the Future Technology of Cardiovascular Care.

The Use of Artificial Intelligence in Cardiology

As the type and breadth of data available to cardiologists and the cardiovascular care team continues to grow more sophisticated, physicians are increasingly being asked to provide more rapid and personalized interpretations of data to their patients. One solution to providing this level of personalized medicine efficiently is artificial intelligence, also known as machine learning.

In the review article Artificial Intelligence in Cardiology,[1] researchers analyze select applications of artificial intelligence in cardiology and identify how the specialty could incorporate more artificial intelligence in the future to enhance the capabilities and experiences of clinicians and patients.

“(Artificial intelligence) has clear potential to enhance every stage of patient care — from research and discovery, to diagnosis, to selection of therapy,” said Joel Dudley, Ph.D., senior author of the review and director of the Next Generation Healthcare Institute at Mount Sinai. “A key next step to incorporating artificial intelligence into cardiology is to align available data and technologies with clinical and business use. This way, we can prioritize short-term opportunities and understand gaps in available data or algorithms that are holding back applications of artificial intelligence in areas of high clinical need.”

According to the review, artificial intelligence is currently only performed by those with specialized training, but in the future, these methods will be increasingly easy and widely available. It may eventually be incorporated into day-to-day practice by interacting with electronic health records and billing.

Use of Digital Health Technology to Generate Data, Deliver Evidence-based Care

Digital health is the use of digital information, data and communication technologies to collect, share and analyze health information to improve patient health and health care delivery. It can broadly include electronic medical records and artificial intelligence applied to large datasets. These technologies have the potential to accelerate, streamline and optimize clinical research operations and reduce costs, but their use comes with concerns about data quality, patient safety and privacy, which contributes to the delay in their use.

In the review paper Using Digital Health Technology to Better Generate Evidence and Deliver Evidence-Based Care,[2] participants from a 2016 think tank on digital health discuss the purpose and findings of the meeting. The participants, which included academic, industry and regulatory representatives, convened to understand the current landscape of digital health technology use in health care delivery and clinical trials, identify issues and barriers to the development and adoption of these technologies, and identify potential solutions.

“These technologies could facilitate and advance more conventional randomized clinical trials (RCTs), which is particularly necessary since RCTs are becoming increasingly expensive and complex, are slow to complete and take an extensive amount of time to implement into practice,” said Abhinav Sharma, M.D., lead author of the review and Stanford University Advanced Heart Failure Fellow (previously a Duke Clinical Research Institute Research Fellow).

Think tank participants reported that there are several solutions that can accelerate the use of these technologies, including: developing innovation networks to rapidly test new innovations, validate findings and provide value cost-effectiveness data; collaborating with regulatory agencies to streamline development; working with professional societies to identify critical knowledge gaps that could be filled by digital health technologies; and expanding the role of public-private partnerships.

Mobile Health Advances in Physical Activity, Fitness and Atrial Fibrillation

Cardiovascular disease management and prevention involves a commitment to heart healthy physical activity, diet, medication adherence and self-monitoring. These daily activities are largely unmeasured, but the emergence and rapid growth of mobile devices and wearables has made continuous health monitoring a possibility and, for many patients, a reality.

Mobile health, or mHealth, is the subset of digital health that focuses on the use of mobile and wearable devices and software applications. Authors in the article Mobile Health Advances in Physical Activity, Fitness, and Atrial Fibrillation: Moving Hearts,[3] provide an update on cardiovascular mHealth, with a focus on research and clinical advances in measuring and promoting physical activity and fitness plus using these same mobile devices for heart rate and rhythm monitoring, especially for atrial fibrillation (AF or Afib).

“Only recently has the medical community started to embrace the reality that most ‘health’ takes place outside the hospital and clinic, namely the daily activities and clinical events that occur ‘the other 362 days’ per year when people are not seen by a clinician,” said Michael McConnell, M.D., MSEE, lead author of the review and clinical professor of cardiovascular medicine at Stanford University and head of cardiovascular health innovations at Verily Life Sciences. “Enabling patients and clinicians to leverage these technologies for proactive health care can transform cardiovascular prevention and disease management.”

The authors specifically looked at Afib because it can go undetected and be difficult to manage. Office visits and short-term monitoring provide limited information on disease presence and burden, which can result in serious complications. However, ongoing monitoring with mHealth devices is an opportunity to prevent strokes, manage symptoms and reduce hospitalizations from atrial fibrillation. Machine learning has emerged as a powerful technology to enhance AF detection from wearable devices. Importantly, physical activity and fitness are also linked with primary prevention of atrial fibrillation and reduced atrial fibrillation burden and recurrence. The authors note the importance of broad collaboration to further integrate mHealth technology into clinical care, with the potential for substantial individual and societal benefits.

For more information: acc.org and JACC.org

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The Future of Cardiology: 17 Technologies to Watch

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References:

1. Kipp W. Johnson, Jessica Torres Soto, Benjamin S. Glicksberg, et al. Artificial Intelligence in Cardiology. Journal of the American College of Cardiology (JACC). Volume 71, Issue 23, June 2018. DOI: 10.1016/j.jacc.2018.03.521.

2. Abhinav Sharma, Robert A. Harrington, Mark B. McClellan, et al. Using Digital Health Technology to Better Generate Evidence and Deliver Evidence-Based Care. JACC. Volume 71, Issue 23, June 2018. DOI: 10.1016/j.jacc.2018.03.523.

3. Michael V. McConnell, Mintu P. Turakhia, Robert A. Harrington, et al. Mobile Health Advances in Physical Activity, Fitness, and Atrial Fibrillation: Moving Hearts. JACC. Volume 71, Issue 23, June 2018. DOI: 10.1016/j.jacc.2018.04.030. 

July 5, 2018 — Philips and Florida’s Jackson Health System, one of the nation's largest public health systems, announced the world's first long-term strategic partnership based on an Enterprise Monitoring as a Service (EMaaS) model.

Designed to support Jackson's efforts to enhance patient safety and continuous monitoring across the network, the partnership will pioneer EMaaS and allow the health system to adopt state-of-the-art patient monitoring systems for a per-patient fee. This new business model will eliminate up-front costs while allowing Jackson to standardize patient monitoring at all acuity levels for each care setting across its network. Creating a more seamless experience for patients and staff to deliver the right care at the right time, the partnership will help Jackson further expand its quality of care for residents of Miami-Dade County.

An integrated healthcare delivery system, Jackson Health System consists of:

• Its centerpiece, Jackson Memorial Hospital, Jackson South Medical Center, Jackson North Medical Center, Holtz Children's Hospital, Jackson Rehabilitation Hospital, Jackson Behavioral Health Hospital;
• A network of UHealth Jackson Urgent Care centers;
• Multiple primary care and specialty care centers; and
• Two long-term care nursing facilities.

The new Jackson West Medical Center campus is under development in the City of Doral, and will feature adult and pediatric emergency rooms and outpatient services.

Unlike traditional business models — where a hospital may purchase and own the patient care monitoring system and is responsible for ongoing upgrades across its network — this new model keeps the ownership with Philips, including all current and future hardware, software and networking solutions. In addition, Philips will provide technical support, help identify clinical workflow optimization opportunities, continuing education, asset and data management. Philips will also help Jackson to design solutions that integrate with core information technology (IT) systems, such as Jackson's electronic medical record (EMR).

"For Jackson, patient safety is paramount, and trying to balance patient safety with the rapidly changing technology landscape requires innovative business models and a true partnership that will allow us to manage our IT needs, while enhancing our quality of care," said Carlos A. Migoya, CEO of Jackson Health System. "This model will assist our drive for operational and clinical excellence through best practices, continuing education and shared accountability, allowing us to focus on what matters most – empowering our staff to deliver the best possible care to our community."

The Philips EMaaS model will give Jackson access to Philips patient care monitoring technologies, as well as innovative monitoring technologies such as the Wearable Biosensor on a per-patient basis. Jackson will also have the flexibility to customize solutions to specific clinical needs as they transition to value-based care and try to deliver on the quadruple aim.

Jackson is the latest healthcare network to sign a long-term, strategic partnership (LSP) with Philips in this business model. Since implementing LSPs in North America, Philips has signed multiple agreements with:

• Augusta University Health (Georgia);
• Westchester Medical Center Health Network (New York);
• Mackenzie Health (Ontario, Canada);
• Marin General Hospital (California);
• The Medical University of South Carolina Health (South Carolina);
• Banner Health (Arizona);
• Bon Secours (Kentucky);
• Phoenix Children's Hospital (Arizona); and
• Children's Hospital & Medical Center Omaha (Nebraska).

For more information: www.usa.philips.com/healthcare

July 24, 2018 - Diagnostic and consumer healthcare remote monitoring technology company Biotricity Inc. has completed the alpha version of its Bioflux 2.0 deep data diagnostic solution in accordance with U.S. Food and Drug Administration (FDA) arrhythmia diagnostic standards.

The company intends to leverage its new AI and deep data technology in arrhythmia analysis in its Bioflux 2.0 solution and focus on improved accuracy, faster diagnostics for patients, more efficient monitoring, and improved call center efficiency.

“We hope our deep data solution will eventually lead to near-instantaneous diagnostics, circumventing some of the current issues inherent in arrhythmia monitors, such as the delay that it takes for a physician to receive and analyze a patient report,” said Waqaas Al-Siddiq, founder and CEO of Biotricity. “If we have the ability to anticipate a problem early we may have the potential to send preventative or predictive alerts.”

Diagnostic failure rates are still relatively high with about 5 percent of adult patients misdiagnosed each year in the U.S. This totals more than 12 million people. Biotricity hopes to employ deep data science to increase the accuracy and efficiency of diagnostics, with the first implementation in its Bioflux 2.0 solution.

The company expects to complete software and hardware prototyping for its new solution and to file a FDA 510(k) clearance application by early 2019.

This device technology is part of a larger trend in remote ECG monitoring devices. Read more on these advances.

For more information: www.biotricity.com

July 23, 2018 — The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the PocketECG Cardiac Rehabilitation System (CRS). The new mobile cardiac rehabilitation system is designed to provide high-quality ECG monitoring and automated arrhythmia detection during rehabilitation training. The clearance was announced by the maker MedicAlgorithmics and U.S. subsidiary Medi-Lynx Cardiac Monitoring LLC.

The device is currently approved and marketed in the European Union and patented in the U.S. (U.S. Patent No. 9,846,764) for use in low and high-risk cardiac patients.

"We are thrilled to now introduce PocketECG CRS to patients and clinicians in the U.S., providing a valuable monitoring tool with the potential to improve the effectiveness of cardiac rehabilitation training," said Marek Dziubinski, Ph.D., CEO of MedicAlgorithmics. "PocketECG CRS was built on our PocketECG arrhythmia monitoring solution platform, and includes new software and enhancements specifically designed for use during all phases of the cardiac rehabilitation process — from early mobilization during hospitalization to post-discharge and ongoing maintenance."

PocketECG CRS is a smartphone-sized device that monitors a patient's heart rhythm and heart rate during rehabilitation exercises to safely guide the intensity and duration of workouts in real-time. The system transmits the full disclosure ECG signal classifying every heartbeat to automatically detect abnormalities and arrhythmia. A built-in accelerometer allows clinicians to analyze the impact of physical activity on heart rate. All data are streamed via mobile telephony network to a secure online clinician portal and to a cardiac monitoring center for constant monitoring, evaluation, and urgent notifications.

Cardiac rehab or medically supervised exercise training is highly recommended by the American Heart Association (AHA) and shown to improve the health and recovery of patients with acute myocardial infarction or heart attack, chronic stable angina, coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), cardiac valve surgery, stable, chronic heart failure and cardiac transplantation. The American Association of Cardiovascular and Pulmonary Rehabilitation estimates that at least 3.8 million patients are eligible to receive cardiac rehabilitation.

This device technology is part of a larger trend in remote ECG monitoring devices. Read more on these advances.

For more information: www.medicalgorithmics.com, www.medi-lynx.com

August 10, 2018 — Caretaker Medical, creator of the Caretaker4 wireless CNIBP Vital signs monitor for continuous non-invasive blood pressure (CNIBP) and vital signs monitoring, has received CE certification approval.

The device has already been recognized as a U.S. Food and Drug Administration (FDA)-cleared wearable vital signs monitor for measuring intensive care unit (ICU) quality continuous beat-by-beat blood pressure, heart rate, SP02 and body temperature. The CE Mark registration will allow the company to immediately expand its global sales and distribution efforts.

The Caretaker4's ability to measure continuous blood pressure and vital signs without bulky external arm cuffs helps to streamline clinician workflow, and improves patient comfort and safety. Additionally, the device's ability to send patient data to other monitoring platforms provides robust integration onto OEM solutions, including Philips IntelliVue monitors.

For more information: www.caretakermedical.net

August 15, 2018 — iBeat recently announced the release and shipping of its iBeat Heart Watch. The heart and blood flow monitoring smartwatch will engage the user and can notify first responders for immediate medical aid if something appears to be wrong.

The iBeat Heart Watch looks and functions like an everyday watch, but inside has an array of sensors that measure heart rate, blood flow and other biometrics. These are analyzed in real-time, leveraging artificial intelligence (AI), to look for potentially worrisome changes, such as heart rate or blood flow slowing or stopping. If something appears to be off, the watch will engage the user and ask if everything is okay. If the user confirms the need for help or does not respond, the Heart Watch will automatically connect to the iBeat’s 24-hour dispatch team, who can send the appropriate help – emergency medical services, police, firefighters, friends or family. The watch also has an emergency button that can be pressed at any time to get users emergency or non-emergency aid.

According to the Centers for Disease Control and Prevention, every 43 seconds, someone in the U.S. suffers a cardiac emergency, and emergency response time can make the difference between life and death. Because these emergencies are often unwitnessed and can happen anywhere, the iBeat Heart Watch has the potential to reduce delays in emergency response times, which could save lives and possibly prevent a user from suffering brain damage or organ failure.

Features of the iBeat Heart Watch include:

• Continuous heart rate and blood flow monitoring – Looks for changes in real-time and alerts the user when there might be a significant or potentially serious change;
• Dispatch and emergency contact notifications – Immediately notifies iBeat’s 24-hour dispatch team, the user’s emergency contacts, and if needed, 911;
• Emergency help button – Can be pressed at any time to get aid from friends, family, loved ones or emergency services;
• No smartphone or wi-fi needed – Equipped with built-in cellular functionality that can send and receive calls for help; no phone, Wi-Fi, or Bluetooth pairing is required to set up or use the watch;
• Built-in GPS – Alerts responders and designated contacts to the user’s exact location in an emergency;
• User dashboard – Shows overall heart health, activity levels, location and any emergency-triggered incidents; and
• Heart Hero Network – Access to the network that makes aid available to anyone, anywhere. With more than 1 million people trained in first aid and cardiopulmonary resuscitation (CPR), the network will be automatically alerted if a nearby iBeat Heart Watch user suffers a cardiac emergency.

While the iBeat Heart Watch is intended for use as an everyday watch or for those with a heart concern, it is also an ideal replacement and upgrade from the antiquated medical alert devices currently on the market, according to the company. Most medical alert systems are pendants that brand the user as sick or elderly and require the user to stay tethered to a base station – unable to be used outside the home. They do not have the ability to measure cardiac parameters or automatically call for help. In contrast, the iBeat Heart Watch is a stylish watch that gives users the freedom to go anywhere they want, whenever they want, and keeps them within reach of immediate emergency or non-emergency aid.

iBeat is pursuing U.S. Food and Drug Administration (FDA) approval for use of its Heart Watch as a medical device and recently partnered with two of the top leading life insurers and reinsurers, Transamerica and SCOR Global Life, to extend longevity.

For more information: www.ibeat.com

August 30, 2018 — At the 2018 European Society of Cardiology (ESC) Congress, cardiovascular technology startup Maisense debuted the Freescan telecardiology system that uses a portable device to measure blood pressure and record electrocardiogram (ECG) readings simultaneously.

Maisense Vice President of Business Development Bach Chen noted that most telecardiology systems on the market either provide only ECG, or provide both blood pressure and ECG but retrieve them from two independent devices. Chen said that the more devices there are, the less likely it becomes that patients will use all of them regularly.

The purpose of Maisense's telecardiology system is to simplify the measurement procedure for patients. Through the combination of three elements — the Freescan device, the myFreescan App and the Patient Care web platform— patients can measure blood pressure and ECG with a single device. In addition, doctors are able to monitor patients' health condition easily through the web-based Patient Care System. Maisense Freescan in combination with the myFreescan App utilizes artificial intelligence (AI) for early atrial fibrillation detection (AFib), arrhythmia (bradycardia and tachycardia) detection, pulse wave velocity and blood pressure monitoring in a single device.

According to the World Health Organization (WHO)'s May 2018 report, stroke incidents are globally the second most common cause of death after ischemic heart disease. Of the 56.9 million deaths worldwide in 2016, almost 6 million people died of strokes — about 10 percent of all the accounted deaths. However, up to 80 percent of strokes may be preventable by monitoring the major risk factors: arterial stiffness, AFib and hypertension.

The adoption of Maisense's telecardiology system will enable every user of the solution to assess their risk level of strokes anytime, according to the company. Therefore then they can take preventive actions to minimize the risk.

For more information: www.maisense.com

August 31, 2018 — Philips announced it has acquired Xhale Assurance Inc., a U.S.-based scale-up company developing and commercializing next-generation sensor technologies. Xhale Assurance’s disposable pulse oximetry sensor is placed on the wing (ala) of the nose, and can reliably measure and transmit a patient’s heart rate and blood oxygenation under low-perfusion conditions that are challenging for conventional fingertip pulse oximetry sensors. Philips said this technology will broaden and differentiate its existing portfolio of oxygen saturation monitoring solutions and allow the company to expand into a currently underserved clinical segment. Financial details of the transaction were not disclosed.

Xhale Assurance’s alar sensor allows accurate measurement at lower oxygen saturation levels, which is essential for patients who have suffered a heart attack or a hypoxic event. As such, the sensor enhances patient safety by overcoming the shortcomings of existing oxygen saturation sensors, and can provide caregivers with early warning signals of impending adverse events.

Philips’ patient monitoring portfolio addresses all acuity levels and care settings within hospitals and health systems, and supports a broad patient population – from basic screening to complex surveillance in critical care. It includes bedside and wearable patient monitors, consumables such as connected wearable biosensors, and clinical decision support tools and mobile applications for real-time clinical information at the patient’s bedside.

For more information: www.usa.philips.com/healthcare

September 5, 2018 — Biotronik announced it is now the exclusive U.S. distributor for the MoMe Kardia external cardiac diagnostic monitor from digital health company InfoBionic. The device benefits patients suspected of experiencing cardiac arrhythmias.

According to InfoBionic, MoMe Kardia is the first and only deep learning software as a service (SaaS) remote cardiac monitoring platform that replicates in-hospital monitoring with full disclosure cardiac data delivered direct to physicians for 24/7 on-demand review via a HIPAA-compliant portal. By giving physicians control of when, where and how they review monitoring reports – as well as access to beat-to-beat data to verify events – MoMe Kardia can significantly reduce time to diagnosis and intervention. The model also positively impacts practice economics by giving physicians full ownership of monitoring services.

Patients experiencing cardiac arrhythmias face an increased risk of personal injury from falls, motor vehicle accidents, stroke and possibly heart failure. MoMe is designed to increase early detection and diagnosis of cardiac arrhythmias by providing physicians with the ability to access near real-time electrocardiographic data. Monitoring can also uncover patients at higher risk of sudden cardiac death. Hospitalizations and life-threatening cardiac events decrease with early diagnosis and treatment.

With automated cloud-based analytics, patient data is immediately available to physicians without the need for costly third-party services. MoMe creates access to information that enables intervention to prevent negative outcomes. Medication compliance can be identified and managed, symptoms can be correlated with rhythms, and triggers of cardiac events can be found by analyzing the onset and resolution data of an event.

Speaking to the benefits his practice has seen since using the MoMe Kardia system, Matthew B. Hillis, M.D., FACC, FHRS of Marple Medical Associates in Broomall, Pa., explained, “The workflow has been more efficient for us from both the staff and physician perspective. Customizable alerts, utilization tracking/inventory management, improved patient comfort and compliance have been beneficial. The quality of ECG [electrocardiogram] tracings is high, and we have found the business model to be useful as well.”

"MoMe is unique in providing near real-time full disclosure electrocardiographic monitoring," said Colin Movsowitz, M.D., electrophysiologist, Philadelphia. "It replicates a hospital telemetry monitoring center. MoMe allows clinical decisions to be made on data rather than assumptions. It sets a new standard in providing physicians easy access to ambulatory electrocardiographic data."

Patients can easily be trained on how to use the one-button monitor. Once the patient is home, physicians can remotely switch the monitor between Holter, Event and Mobile Cardiac Telemetry — lessening the need for office visits and saving time and money for the patient. From enrollment to diagnosis, physicians have total control of the monitor.

For more information: www.infobionic.com, www.biotronik.com