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VitalPatch


Vital Connect Launches VitalPatch Biosensor at HIMSS 2016

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Vital Connect, VitalPatch, disposable biosensor, HIMSS 2016

March 3, 2016 — Vital Connect debuted the VitalPatch biosensor at the 2016 Healthcare Information and Management Systems Society (HIMSS) conference and exhibition, Feb. 29-March 4 in Las Vegas. With the global market for biosensors to monitor health projected to exceed $40 billion annually by 2020, the company is introducing the all-in-one, single-use, fully disposable wearable developed to support clinical decision-making.

Powered by Vital Connect’s proprietary VitalCore processor, the VitalPatch is the next evolution of Vital Connect’s U.S. Food and Drug Administration (FDA)-approved HealthPatch MD biosensor. The same continuous measurements available in HealthPatch MD are now included in a peel-and-stick, single-use device. The lightweight, wireless, adhesive patch continuously monitors and records single-lead electrocardiogram (ECG), heart rate, heart rate variability, respiratory rate, skin temperature, posture, step count and fall detection with clinical accuracy. Through the Vital Connect platform, care teams receive accurate data and notifications to make health decisions and enable timely interventions.

The device has a streamlined, flexible profile that is unobtrusive during a patient’s activities of daily living. Also, since the patch is fully disposable, there is no potential for cross-contamination and no need for the patient or clinical staff to manage reusable components.

With the VitalPatch, patients may be monitored at any location where continuous monitoring offers the opportunity for early detection of patient deterioration and early intervention by care teams.

For more information: www.vitalconnect.com

New Biotronik Insertable Cardiac Monitor Available in the U.K. and Ireland

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Biotronik, BioMonitor 2, AF remote monitoring, atrial fibrillation, U.K. and Ireland

March 14, 2016 — Biotronik announced that its BioMonitor 2 heart monitor is now available for patients in the United Kingdom. The insertable device allows highly accurate and reliable continuous detection of cardiac electrical events.

The monitor is indicated for patients suffering from unexplained syncope, and to detect atrial fibrillation (AF). Diagnosing the irregular heartbeat condition AF is notoriously difficult, as is finding the root cause of syncope — a condition where the patient passes out due to decreased blood flow to the brain. If left untreated, both can be life threatening.

In response, BioMonitor 2 can be inserted under the skin of the patient in a simple procedure. It then records all cardiac electrical events. Data from the device is transmitted directly to the physician via Biotronik Home Monitoring, where they are given an accurate map of the heart’s activity right on their computer screen.

“AF is often so sporadic and unpredictable that it is sometimes impossible to diagnose at the time the patient has symptoms,” commented Riyaz Kaba, M.D., from Ashford and St Peter’s Hospitals, Surrey, and St George’s Hospital, London. “It is similar with syncope. The patient can hardly choose to faint when they are hooked up to an ECG just so we can find out what’s causing it. But, because BioMonitor 2 is always on and always recording, we can see exactly what’s going on with their cardiac rhythm in these precise moments. It’s really unprecedented and the accuracy of the readings has exceeded our expectations. We get a clear picture very early on, meaning necessary treatment can begin earlier.”

As well as its diagnostic benefits, the device has been designed with the patient anatomy in mind. “The insertion procedure is easy for both doctor and patient. It only takes a few minutes,” explained Kaba. “The monitor adapts to the patient’s anatomy, and they’re satisfied with the overall cosmetic result.”

BioMonitor 2 also has Biotronik ProMRI technology and is approved for full-body magnetic resonance imaging (MRI) scans at both the usual 1.5 and ultra-high 3.0 tesla strength. Its average battery life is four years, topping the industry standard by a year.

For more information: www.biotronik.com

BioMonitor 2

New Kardia Band for Apple Watch Delivers Medical-grade ECG Anywhere

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Kardia Band, Alivecor

The Alivecor Kardia Band for the Apple Watch enables anyone to perform a medical-grade ECG anywhere.

AliveCor, Inc., the leader in FDA-cleared electrocardiogram (ECG) technology for mobile devices, announced today the introduction of the first medical-grade ECG band for the Apple Watch, Kardia Band (pending FDA (510)k clearance, expected availability late spring) along with a new app for smartphones (available now). The Kardia Band for Apple Watch, and new Kardia app, represent a significant breakthrough in proactive heart health by allowing people to discretely capture their ECG anytime, anywhere.

Users can record a single-lead ECG by simply touching Kardia Band’s integrated sensor that communicates with the Watch app, Kardia by AliveCor. The atrial fibrillation (AF) detector then uses Kardia’s automated analysis process (algorithm) to instantly detect the presence of AF in an ECG, the most common cardiac arrhythmia and a leading cause of stroke. Also included is the Normal Detector, which indicates whether your heart rate and rhythm are normal, and the unreadable detector, which tells you when to retake an ECG so physicians receive only the highest quality recordings.

Users can also record voice memos on their Apple Watch to accompany each ECG that give doctors and caregivers a clearer picture of what was happening at the time of the recording — describing symptoms such as palpitations or external factors like caffeine intake. Kardia also integrates seamlessly with Apple’s Health app to include ECG data with steps and calorie intake to provide richer, personal analysis over time.

“Kardia Band for Apple Watch represents both the future of proactive heart health and the introduction of the Wearable MedTech category,” said Vic Gundotra, chief executive officer of AliveCor. “These combined technologies give us the ability to deliver personal reports that provide analysis, insights and actionable advice for the patient and their doctor.”

“The personal, discrete Kardia Band is a perfect fit for Apple Watch. It allows patients to easily measure and record their heart rhythm in real time. This can provide patients with a sense of control—which is vitally important to successful patient engagement in the treatment of chronic disease,” said Kevin R. Campbell, M.D., FACC, North Carolina Heart and Vascular UNC Healthcare, clinical cardiac electrophysiology assistant professor, UNC Department of Medicine, Division of Cardiology, and President, K-Roc Consulting, LLC.

Kardia Band is designed for anyone who wants to learn more about their health in addition to people with AF, and doctors who want to bring the latest in proactive heart health technology to their patients and practices. Kardia Band provides caregivers the opportunity to take a more active role in helping their loved one engage in their own care. The Kardia Band is pending 510k clearance and is not currently for sale in the United States.

AliveCor has re-introduced its first device, the AliveCor Mobile ECG, under the new Kardia brand name as Kardia Mobile. This change establishes a family of products and makes the name Kardia synonymous with proactive heart health. Currently, Kardia Mobile works with iPhone, iPad and iPod touch, and most Android OS. The new Kardia app is available now for download for iOS and Android users.

For more information: alivecor.com

 

Reference:

1. Based on the number of published clinical studies using Kardia Mobile compared to other smartphone-based EKG devices.

Lung Congestion Detection Device Improves Heart Failure Outcomes

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Edema Guard Monitor, RS MEDICAL

April 15, 2015 — In patients with heart failure, use of an investigational device that monitors the accumulation of fluid in the lungs appeared to cut heart failure-related hospitalizations by more than half. The Edema Guard Monitor met the study’s primary endpoint and reduced deaths from any cause by 39 percent per year compared with standard assessment and treatment, researchers reported at the American College of Cardiology 2016 meeting. 

The Edema Guard Monitor alerts patients to an increase in fluid in the lungs, also called pulmonary congestion or edema, before they have symptoms, said Michael K. Shochat, M.D., of Hillel Yaffe Heart Institute in Hadera, Israel, and lead author of the study. Shochat is also president of RS Medical Monitoring, the Israel-based company that manufactures the Edema Guard Monitor.

“By the time a patient shows clinical signs of pulmonary congestion, the condition is already at an advanced stage,” Shochat said. “Many patients need emergency hospitalization and have a high probability of sustaining irreversible damage to the heart and lungs. In this study, patients who used the Edema Guard Monitor started taking medication well before pulmonary congestion reached an advanced stage.”

The Edema Guard Monitor — a stand-alone device — measures lung impedance, or resistance to electrical current, Shochat said. Healthy, air-filled lungs are highly resistant to electrical current, whereas lungs swollen by fluid are less resistant. In pulmonary congestion, the lungs gradually become more and more swollen by fluid. Existing techniques for monitoring worsening pulmonary congestion, such as periodic chest X-rays or computed tomography (CT) scans of the lungs, are costly or not highly effective. Preliminary studies had suggested that lung impedance-guided treatment could reduce hospitalizations for heart failure.
“This study shows for the first time that a noninvasive lung impedance monitor can be used to detect pulmonary congestion in its earliest stages and that adequate medical treatment at that early stage can significantly reduce both hospitalizations and mortality,” Shochat said.

The IMPEDANCE-HF trial was conducted at two medical centers in Israel and included 256 patients with chronic heart failure whose hearts were pumping blood at less than half of the normal rate. Patients were 67 years of age on average, and 80 percent were male. Before patients were randomized, they received three months of treatment through outpatient clinics to achieve maximal doses of guideline-directed medications to manage congestive heart failure. All patients attended monthly outpatient visits during which a technician measured their lung congestion using the Edema Guard Monitor and their physician performed a standard clinical assessment.

Patients were randomly assigned to one of two groups. In the treatment group, medication was prescribed or adjusted at each visit based on the results of clinical assessment and lung congestion measurement with the Edema Guard Monitor. In the control group, medication was prescribed or adjusted based on clinical signs of lung congestion. The primary endpoint was hospitalizations due to heart failure. Secondary endpoints were hospitalizations and deaths from any cause. The average follow-up time was 48 months in the treatment group and 39 months in the control group.

In the treatment group compared with the control group, hospitalizations due to heart failure decreased by 58 percent during the first year of treatment, and the frequency of heart failure-related hospitalization decreased by 56 percent per year during the entire follow-up period, meeting the study’s primary endpoint. For the entire follow-up period, deaths from heart failure were reduced by 62 percent per year and deaths from any cause decreased by 39 percent per year in the treatment group compared with the control group.

The hope is that patients will eventually be able to use the device at home to measure their lung impedance once or twice a day, Shochat said.

A limitation of the study is that it excluded patients with less severe heart failure, or those whose hearts were pumping blood at more than half of the normal rate, and that the results cannot be extended to that group of patients, Shochat said. Results from an ongoing randomized trial of the Edema Guard Monitor in patients with less severe heart failure are expected in 2019.

The study was funded by the medical centers where it took place. RS Medical Monitoring provided the devices used in the study as well as technical support in their use.

The study was published in the Journal of Cardiac Failure simultaneously with its presentation at the scientific session.

 

New Case Series Examines CardioMEMS in Single Ventricle Fontan Anatomy

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CardioMEMS, implantable hemodynamic monitor, Fontan anatomy, Nationwide Children's Hospital, Wexner Medical Center

May 2, 2016 — In a recent case series, clinicians from The Heart Center at Nationwide Children’s Hospital and The Ohio State University Wexner Medical Center describe the first implantable hemodynamic monitor (IHM) placement in single-ventricle Fontan anatomy. To date, Nationwide Children’s is the first pediatric hospital to perform the procedure, while Ohio State’s Wexner Medical Center is the first hospital to perform the procedure in a Fontan patient. The case series is published in the journal Catheterization and Cardiovascular Interventions.

While the Fontan procedure has improved the short- and mid-term outcomes for patients born with single-ventricle anatomy, long-term complications of Fontan circulation include heart failure. These complications are thought to be secondary to elevated central venous pressure, chronic venous congestion and low cardiac output.

“This pressure gradient between central venous pressure and a combination of ventricular end diastolic pressure and resistance of flow across the pulmonary vascular bed is critical to cardiac output,” explained Darren Berman, M.D., co-director of cardiac catheterization and interventional therapy in The Heart Center at Nationwide Children’s. “Recently, implantable hemodynamic monitors have been used to monitor pressures in patients with left heart disease.”

Noninvasive studies are unable to determine these pressures in the Fontan anatomy, thus limiting physicians’ understanding of the changes in pressure for a Fontan patient in heart failure, according to Curt Daniels, M.D., director of adolescent and adult congenital heart disease in The Heart Center at Nationwide Children’s and professor of clinical cardiology at The Ohio State University College of Medicine.

“Our ultimate goal is to improve care for patients with congenital heart disease,” said Daniels. “We are excited to be leading the charge to incorporate the use of this tool to learn more about the hemodynamic changes in real-life ambulatory situations in Fontan patients.”

Two patients with single-ventricle anatomy and Fontan physiology, both with New York Heart Association (NYHA) functional class III heart failure, were implanted with the CardioMEMS HF System by Berman and Daniels. Real-time pulmonary artery catheter tracings were shown to correlate with IHM tracings in Fontan anatomy. Additionally, home transmission of IHM readings was successful.

“We have shown early safety and feasibility of placement of the IHM in these two cases, and we will follow these patients to monitor the safety in the medium- and long-term, including assessment for pulmonary arterial thrombus,” said Berman, who is also an assistant professor at OSUCM.

Berman, Daniels and coauthor Elisa Bradley, M.D., cardiologist at Nationwide Children's and assistant professor at OSUCM, hope that, as it does in patients with non-congenital heart disease, monitoring hemodynamic information from the transmissions will translate to improved fluid balance and heart failure symptoms, including reduced hospital admissions.

For more information: www.onlinelibrary.wiley.com

Caretaker Medical


CareTaker Wireless Remote Patient Monitor

FDA Approves CareTaker Wireless Remote Patient Monitor

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CareTaker Medical, wireless remote patient monitor, continuous blood pressure, heart rate, FDA clearance

May 12, 2016 — CareTaker Medical announced that the U.S. Food and Drug Administration (FDA) has issued 510(k) clearance for the company's Wireless Continuous Non-Invasive "Beat-by-Beat" Blood Pressure ("cNIBP") and Heart Rate Monitor. The device is based on patented Finger Cuff technology. 

The wearable CareTaker monitor enables uninterrupted wire-free and electrode-free vital signs monitoring throughout the full mobile continuum of care; within the clinic and hospital, during patient transport and remotely after patient discharge.  Using a comfortable, low-pressure finger cuff, CareTaker's patented Pulse Decomposition Analysis technology non-invasively measures continuous beat-by-beat blood pressure with accuracy exceeding Association for the Advancement of Medical Instrumentation (AAMI) requirements. The device also measures heart rate as accurately as a three-lead electrocardiogram (ECG) for remote display on the CareTaker secure Web portal or other wireless devices.

Historically, most continuous beat-by-beat blood pressure measurements require an invasive arterial catheter or complex equipment, and have therefore been used mainly in critical care settings. The CareTaker cNIBP technology delivers ICU-quality continuous measurements without intrusive catheters or cumbersome wires, giving clinicians the ability to identify hemodynamic deterioration trends early, allowing more time for intervention while providing a comprehensive view of a patient's hemodynamic status.  

CareTaker's comfortable finger cuff is gentle enough to be worn continuously, even during sleep, and usage is intuitive enough to ease the clinician's workflow. The system’s onboard cellular and Bluetooth communication capabilities allow for simple setup and deployment as well as seamless integration with other devices, remote patient monitoring platforms and hospital electronic medical record systems.

"CareTaker is a real game changer, allowing physicians to remotely monitor medical-grade continuous blood pressure and heart rate from anywhere, using only a patient friendly-finger cuff," said Jay Sanders, M.D., professor of medicine (adjunct) at Johns Hopkins School of Medicine and president emeritus of the American Telemedicine Association. "Until now, most clinicians have had to settle for intermittent 'point-in-time' blood pressure measurements using bulky arm cuffs, which can produce misleading results due to the influence of many factors such as movement, posture, anxiety or caffeine. In remote monitoring settings, the ability to gather continuous blood pressure and vital sign data from such an integrated, easy-to-use device will provide better information and improve patient compliance while reducing cost and workload."

For more information: www.caretakermedical.net

New Study Evaluates Wireless Remote Monitoring System for Heart Failure Patients

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Ambio Health telemonitoring system, LifeBridge Health Cardiovascular Institute, Baltimore, pilot study

May 26, 2016 — The LifeBridge Health Cardiovascular Institute, Baltimore, has launched a pilot study to evaluate the potential benefits of a wireless heart monitoring system for patients with moderate to severe heart failure. The system tracks weight, blood pressure and other measures, and automatically sends the information to doctors and staff at the Cardiovascular Institute. The study is looking at whether this approach, designed to be simple and easy-to-use, can result in better outcomes for patients with heart failure.

“With heart failure, sudden increases in body weight and other measures could indicate that the heart is having issues pumping blood and the patient’s condition is worsening. However, these issues can often be corrected with early intervention, which is why telemonitoring has the potential to be so effective in keeping people out of the hospital,” explained Mauro Moscucci, M.D., M.B.A., medical director of the LifeBridge Health Cardiovascular Institute and chief of medicine at Sinai Hospital of Baltimore.

He added, “We are eager to see if this simplified system is associated with consistent use and if it can allow close monitoring of patients’ conditions and optimal management without the need of frequent office visits. The eventual hope is that the system will be easy and cost-effective enough to expand telemonitoring to patients with less severe heart failure, with the ultimate goal of keeping people well and out of the hospital.”

The study is the first clinical trial to include patient education and care plans developed by the American Heart Association (AHA) through its new technology initiative known as Connected Heart Health. By combining the medical monitoring with the Connected Heart Health information, researchers will look to see if the program may keep participants motivated over time, including modifying or changing behaviors.

“Connected Heart Health was designed with the patient in mind, stimulating engagement and active involvement in their health,” said Janet Bettger, Sc.D., a health services researcher at the Duke Clinical Research Institute and an AHA volunteer who helped developed the plans. “AHA is committed to evaluating how we can use innovative technology to reach large cross-sections of the population and improve health, and this study will give us valuable insight.”

A key component of the study is the “ease of use” for participants. They receive training to take their own blood pressure, glucose levels and weight every day using devices that are specifically designed to be simple to use. These devices automatically send the daily readings (through a wireless connection) to the medical team at Sinai Hospital.

The doctors and other staff receive alerts if a participant’s numbers are dangerously high, so they let the patient know and take whatever immediate action may be necessary. The researchers can also track changes over time, so they may be able to spot a potential medical problem before it becomes more serious.

“One of the challenges with telemonitoring has been getting patients to measure their blood pressure and weight consistently and report their results. We are interested to see if this remote wireless technology will make it simpler and easier for them to be more consistent. We are also looking at how we can use the information developed by the American Heart Association to keep participants motivated,” explained Moscucci.

Patients receive an email daily with their AHA “CarePlan” activities. Along with a summary of their medical data, they can answer questions about how they feel, such as if they have any shortness of breath or if they are experiencing other symptoms. They can also enter details about how they are eating and exercising.

The AHA’s Connected Heart Health program provides personalized information, based on the profile the patient builds. One person may receive a tip about low cholesterol foods, while another may take an interactive assessment on sleep — all aimed at keeping participants interested and engaged.

The monitoring system, developed by Ambio Health, can also send reminders to patients about taking their medicines and doing their daily health assessments. Ambio is also evaluating whether a more affordable telemonitoring system could potentially lead to broader use for patients with heart disease risk factors such as high blood pressure. (Due to the high cost, telemonitoring has traditionally been reserved for heart failure patients with more severe disease).

Although not usually part of heart failure telemonitoring, glucose monitoring is included in this study because people living with heart failure often have other chronic conditions, including diabetes.

The trial will enroll 50 people with moderate to severe heart failure who will receive three months of telemonitoring, along with a follow-up one month later. Along with evaluating the clinical measurements (weight, blood pressure and blood sugar), researchers will look at quality of life measures (such as the ability to climb a flight of stairs or carry groceries), patient engagement, behavior changes and hospital readmissions.

For more information: www.lifebridgehealth.org

CardioMessenger Smart

Biotronik Launches CardioMessenger Smart Portable Device

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Biotronik, CardioMessenger Smart, remote monitoring, ICD, pacemaker

June 1, 2016 — Biotronik announced the launch of CardioMessenger Smart in the United States. CardioMessenger Smart is a portable monitoring device, about the size of a modern smartphone, that keeps pacemaker, implantable cardioverter defibrillator (ICD) and insertable cardiac monitor (ICM) patients connected to their physician remotely, enabling more efficient care management anywhere in the world.

The device provides secure, fully automatic transmission of vital information from a patient’s cardiac implant to their physician via Biotroink Home Monitoring. This includes daily, automatic reports and fully customizable alerts that can be programmed to the physician’s specifications. As demonstrated by the TRUST, COMPAS and IN-TIME clinical studies, Home Monitoring can significantly reduce hospitalization, stroke and mortality. CardioMessenger Smart recently received U.S. Food and Drug Administration (FDA) approval.

“The clinical and economic benefits of remote monitoring have been well established over a decade of clinical studies,” stated Niraj Varma, M.D., in reference to the 2015 Heart Rhythm Society Expert Consensus Statement on remote monitoring. “But these benefits are only realized if patients consistently use the technology. When we make the remote monitoring process easy for patients, we increase the likelihood of patient adherence, which has been demonstrated to improve health outcomes.” Varma was lead investigator for the TRUST Trial, which laid the foundation for the guidelines, and co-chair of the HRS committee.

The portability of CardioMessenger Smart helps ensure patient compliance and the consistent transmission of data necessary for physicians to identify and prevent potential cardiac events. CardioMessenger Smart is fully automatic, providing daily reports of cardiac activity via worldwide cellular networks to physicians without intervention from the patient.

For more information: www.biotronik.com

BePATIENT

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

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