May 8, 2023 — Ucardia, a cardiac conditioning software developer, announced today that it has reached an agreement to acquire Phas3, a pioneer in home-based cardiac rehab and fellow industry leader. This acquisition will result in a comprehensive, market-leading solution for providers, payers, and consumers, covering all facets of cardiac rehabilitation, conditioning, and remote monitoring for patients affected by cardiovascular disease (CVD). 

"With Phas3's compelling software that allows clinicians a convenient way to remotely monitor and engage their cardiac patients, we are confident we have a market-first product that truly allows for patient- and provider-partnered cardiac care for all modalities of remote care – from patients immediately post-discharge from a cardiac event who cannot attend traditional cardiac rehab, to patients looking for a supervised program to strengthen their heart at home," said Nick Weber, Ucardia's co-founder and CEO. 

Ucardia and Phas3 will continue to support all existing customers and their patients in the companies' joint portfolio and are excited to begin planning exciting new products and services that take advantage of their combined strengths. 

"We are pleased to join the Ucardia family and share the company's vision of serving even more CVD patients with our unique and powerful combination of software and clinical services" said Lucas Rydberg, Phas3's co-founder and CEO. 

Jointly with this acquisition, Ucardia is announcing its newest offering, Ucardia-at-Home, a comprehensive remote patient monitoring platform that enables cardiologists and physician practices to enhance the monitoring, engagement, education, and self-management of patients between traditional doctor visits and close the gap in patient care management. 

"We see serving the physician practice segment as a natural extension of the missions of both Phas3 and Ucardia – continuing to make sure every CVD patient has the opportunity to receive critical monitoring and care while in the comfort and convenience of their home," said Dan Ebeling, co-founder and COO of Phas3. "We believe in extending access to every patient who needs this essential care." 

For more information: www.ucardia.com

June 13, 2023 — A recent study highlights that implantable cardioverter-defibrillator (ICD) patients with new-onset atrial high-rate episodes (AHRE) often show high stroke risk while not being on oral anticoagulation (OAC), underlining the relevance of continuous AHRE burden monitoring.1 The study also reports that the combination of BIOTRONIK’s unique DX ICD system with Home Monitoring is an effective and convenient way to detect AHRE.1 

REACT DX is a prospective, multi-center registry that enrolled 234 de novo ICD patients from 14 centers in Germany. It assessed the incidence of new-onset AHRE in an ICD population and the physicians’ reaction using the DX ICD system, a single-chamber ICD enhanced with a floating atrial sensing dipole. Performed in a real-life setting, REACT DX demonstrated the in-practice utility of DX Technology in combination with Home Monitoring for remote AHRE detection, atrial fibrillation (AF) diagnosis and subsequent therapy decision making. 

"AHRE can be a precursor or subclinical form of AF, which can increase the risk of stroke and other cardiovascular complications. Its timely detection and burden assessment is therefore crucial for a timely response, for example in the form of stroke prevention," says PD Dr. Carsten Lennerz, Senior Physician, German Heart Centre Munich, Department of Electrophysiology, Technical University of Munich, Germany. "As demonstrated by the study, the detection of new-onset AHRE by the DX ICD system in combination with Home Monitoring often led to initiation of oral anticoagulation for stroke prevention." 

However, the study findings suggest that the time period until therapy initiation could be reduced further. To support this and harness the full potential of DX and Home Monitoring, the study authors propose a specific protocol for managing remotely detected AHRE. This protocol, a simple decision tree, is based on each patient’s AHRE burden and stroke risk and aims to improve response times for OAC prescription.  

"The results of the REACT DX registry further strengthen the already substantial body of clinical evidence supporting the value of DX Technology in combination with Home Monitoring. Moreover, they emphasize the potential benefits for patients and clinicians, paving the way for more prompt, precise and patient-specific care. We are committed to providing innovative healthcare solutions that deliver real-world results and empower clinicians with tools which can ultimately improve patient outcomes," said Dr. Andreas Hecker, President CRM/EP at BIOTRONIK. 

The REACT DX study adds to the body of research supporting the benefits of DX Technology, extending the clinical evidence. Notably, the MATRIX study, the largest clinical evaluation of DX Technology to date2, has also recently been published. 

For more information: https://www.biotronik.com/en-de 

References: 

1. O'Connor, Matthew et al. (2022): REACT DX registry: Real world REACTion to atrial high rate episodes detected in implantable cardioverter-defibrillator recipients with a DX lead. In Technol Health Care. 2022 Nov 17. doi: 10.3233/THC-220432. Online ahead of print. 
2. Hindricks G., Theuns, D., Bar-Lev D. et al.: Ability to remotely monitor atrial high-rate episodes using a single-chamber implantable cardioverter-defibrillator with a floating atrial sensing dipole, EP Europace, 2023;, euad061, https://doi.org/10.1093/europace/euad061 

June 21, 2023 — Qardio, a leading innovator in healthcare technology, has unveiled its groundbreaking Livestream solution suite, which includes continuous ECG, Blood Pressure, Pulse Oximetry (SPO2), Body Temperature, Weight, and Body Position monitoring, marking a significant leap forward in real-time virtual patient care.  

These cutting-edge real-time solutions have the potential to revolutionize the practice of medicine in many settings, including, Transition of Care, Hospital at Home, Step-Down Units* (e.g., Critical Care/Telemetry/Cardiac), Remote Patient Care, Cardiac Rehab, and even Emergency Departments*.   By improving the ability of healthcare professionals (HCPs) to provide virtual care outside of clinical settings, HCPs can intervene quickly when patient health declines, thereby improving patient outcomes.  Early intervention can potentially reduce healthcare costs by decreasing hospital readmission and accelerating the transition of care.   

The key breakthrough of Qardio's advancements lies in the Livestream ECG system, which provides physicians with real-time ECG readings that are not limited to 30 seconds. It also features the QardioCore technology, which allows patients to take ECG readings without shaving or adhesive patches. 

Mike Alvarez, Qardio's CEO, states, "Qardio's dedicated team of software engineers and scientists are solving some of healthcare's most pressing needs.  Our mission is to reduce costs while improving healthcare with artificial intelligence-derived solutions.  We are leveraging these solutions to improve outcomes for payers, healthcare professionals, and patients.  Livestream ECG is a perfect example of providing data to the practitioner that can improve outcomes quickly and cost-effectively. Qardio is unique in its ability to provide a remote real-time picture of patient health for Heart Failure, Hypertension, COPD, and Cardiac Rehab."    

*The device is not intended for use on critical care patients. 

For more information: www.qardiomd.co

July 11, 2023 — FIRE1 announced that the first U.S. patients have been successfully implanted with its FIRE1 System for remote heart failure monitoring in an Early Feasibility Study. The study will assess FIRE1’s novel solution to improve outcomes for heart failure patients. The first patient was implanted at Austin Heart, Texas, where Kunjan Bhatt, MD, leads the study as Principal Investigator and Thomas McMinn, MD, performed the implants.

“We are delighted to announce the first implants in the U.S. of this new, transformative technology for patients with chronic heart failure,” said Dr. Bhatt. “The procedures were very straightforward, and the patients tolerated the procedure well without any complications. We are excited to use the unique insights we will get from this device to improve patient care. On behalf of Austin Heart, the Heart Hospital of Austin, and St. David’s Healthcare, we are honored to launch research of this technology in the U.S.”

“This device may offer a completely new way of measuring chronic heart failure,” said Nir Uriel, MD, National Principal Investigator for the study and Director of Heart Failure, Heart Transplant and Mechanical Circulatory Support programs at New York-Presbyterian. “The data gathered outside of the U.S. has been promising, and we look forward to studying its use in the U.S.”

Dr. Uriel is also a Professor of Medicine in the Division of Cardiology at Columbia University Vagelos College of Physicians and Surgeons and an adjunct Professor of Medicine in the Greenburg Division of Cardiology at Weill Cornell Medicine.

FIRE1 CEO and President Conor Hanley said, “We have made great clinical progress in Europe and I am proud to announce the milestone of first cases in the U.S., the largest healthcare market in the world. I want to express my gratitude to all the patients who continue to put their faith in us and their care teams who are working tirelessly to bring this important technology to market. The FIRE1 team is committed to its mission of helping millions of patients living with heart failure to get their normal lives back, and today is an important step forward on this journey.”

For more information: www.fire1foundry.com

July 21, 2023 — AliveCor, a leading innovator in FDA-cleared personal electrocardiogram (ECG) technology, today announced a partnership with the Jefferson Narcotic Addiction Rehabilitation Program (NARP) and Thomas Jefferson University Hospital in Philadelphia to evaluate the benefits of QTc monitoring with KardiaMobile 6L for patients receiving methadone maintenance therapy for opioid use disorder.  

In the six-month pilot study, healthcare professionals will use KardiaMobile 6L, the only medical-grade, six-lead personal ECG device that is FDA-cleared to measure QTc intervals, to detect QT prolongation, a potentially dangerous side effect associated with certain medications like methadone. 

“We are excited to partner with Thomas Jefferson University Hospital on this important study that will illuminate the benefits of real-time QTc interval monitoring with KardiaMobile 6L on patients’ outcomes and their treatment experience,” said Patricia Baran, Senior Vice President, Enterprise North America & Biopharma Worldwide. “By enabling clinicians to efficiently detect cardiac side effects, they can better counsel patients about taking the appropriate steps to mitigate risks to their heart health.” 

“Rapid, point-of-care devices can have an important role in streamlining the cardiac safety monitoring required by many behavioral disorder medicines, which are a critical part of comprehensive treatment strategies for people with substance use disorders,” said William Jangro, DO, Medical Director, Jefferson NARP.  

“We look forward to assessing how efficient QTc monitoring with KardiaMobile 6L increases compliance with guideline recommendations, improves the patient experience, enhances treatment, and allows for interdepartmental collaboration,” said Daniel Frisch, MD, Associate Professor of Medicine Electrophysiology Section, Thomas Jefferson University Hospital. 

KardiaMobile 6L was cleared by the FDA in July 2021 for use by healthcare professionals to calculate patients’ QTc interval. 

About the Pilot Study:  

During the six-month pilot, each new patient and each patient undergoing an annual physical at Jefferson NARP will have their ECG recorded with KardiaMobile 6L to detect potential QT prolongation. Recordings will be automatically uploaded to the clinic’s KardiaStation, AliveCor’s workflow solution for in-person instant ECG analysis. 

For more information: www.alivecor.com 

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August 7, 2023 — Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i today announced that several products in its market-leading cardiac ablation portfolio have received approval for a zero fluoroscopy workflow from the U.S. Food and Drug Administration (FDA). The products that can be used in this workflow include: THERMOCOOL SMARTTOUCH SF catheter -- the most commonly used ablation catheter in the world for RF ablation, THERMOCOOL SMARTTOUCH Catheter, CARTO VIZIGO Bi-Directional Guiding Sheath, PENTARAY NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheters, and Webster CS Catheter. The updated workflow indicates that direct imaging guidance, such as ultrasound, may be used as an alternative to fluoroscopy. 

Fluoroscopy is a type of medical imaging that shows a continuous X-ray image on a monitor, and is used in a variety of examinations and procedures to diagnose or treat patients.1 Fluoroscopy can result in relatively high radiation doses, especially for complex interventional procedures which require fluoroscopy be administered for a long period of time.1 Reducing fluoroscopy lowers radiation exposure, which may minimize long-term cancer risk, and can reduce the risk of musculoskeletal pain due to extensive wear of heavy personal protective equipment, such as lead aprons.2 

"Cardiac ablation procedures for the treatment of atrial fibrillation (AFib) usually require fluoroscopy to guide the advancement and positioning of intracardiac catheters, resulting in considerable radiation exposure for patients, operators, and support medical staff as well as a high orthopedic burden from protective equipment such as lead aprons,"2 explained Jose Osorio, MD, FHRS, President of Heart Rhythm Clinical and Research Solutions.ii "Eliminating or reducing radiation exposure is beneficial to patients as well as physicians and staff working every day in the electrophysiology lab."  

"The label change approved by the FDA underscores that the Biosense Webster integrated ecosystem, anchored by the CARTO® 3 mapping and navigation system, together with our diagnostic and treatment catheters, enables workflows with zero fluoroscopy, which improves safety, and efficiency of cardiac ablation procedures," said Jasmina Brooks, President, Biosense Webster. "As a result of this update, our teams can now proactively discuss the fluoroscopy alternative workflow with our customers to reinforce the benefits of the Biosense Webster portfolio of products." 

The company received the label change based on an observational, prospective, multicenter registry that assesses real-world catheter ablation clinical outcomes, including procedural efficiency, safety, and long-term effectiveness in a broad group of patient populations with novel radiofrequency (RF) technologies in paroxysmal AFib patients. The REAL AF Registry is a first-of-its kind real-world evidence registry in the electrophysiology field, led by physicians and supported by Biosense Webster since 2019. 

"At Biosense Webster, we are committed to advancing innovative technologies that enable safe, effective, and efficient cardiac ablation procedures, as well as expanding the body of evidence supporting how our technologies are used to improve patient lives," said Anthony Hong, Vice President, Preclinical & Clinical Research and Medical Affairs, Cardiovascular & Specialty Solutions, Johnson & Johnson. "Our novel approach to evidence generation, utilizing real-world evidence from the REAL AF Registry, has helped us secure regulatory approval for our fluoroscopy alternative workflow, and I'm looking forward to utilizing this approach in the future to lower study costs and achieve faster regulatory milestones." 

Cardiac arrhythmias are a growing epidemic. AFib alone is the most common type of cardiac arrhythmia and impacts nearly 37.5 million people worldwide, and 6 million people in the U.S.3,4 AFib is a progressive disease, and if left untreated can get worse over time or lead to other serious complications like heart disease or stroke.5,6 Catheter ablation is a safe and effective procedure to restore the heart's incorrect electrical signals, which causes an abnormal heart rhythm.7 

For more information: www.biosensewebster.com 

References: 

i Johnson & Johnson MedTech comprises the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson's MedTech segment.

ii Heart Rhythm Clinical and Research Solutions, LLC has received research funding from Biosense Webster Inc. for REAL AF Registry conduct and for supporting medical writing and statistical analysis of study related publications under the direction of the authors. Dr. Jose Osorio and the authors were not compensated for their effort in the publications.

1 FDA. Fluoroscopy: FDA. U.S. Food and Drug Administration. https://www.fda.gov/radiation-emitting-products/medical-x-ray-imaging/fluoroscopy

2 Canpolat, U. et al (2020). State of Fluoroless Procedures in Cardiac Electrophysiology Practice. J Innov Cardiac Rhythm Management. 11(3), 4018–4029.

3 Lippi, G., Sanchis-Gomar, F., & Cervellin, G. (2021). Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. International journal of stroke : official journal of the International Stroke Society, 16(2), 217–221.

4 Kornej J, Börschel CS, Emelia J. Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century. Circulation Research. 2020 June;127(1):4-20. doi: 10.1161/CIRCRESAHA.120.316340

5 Calkins, H., et al (2017). 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart rhythm, 14(10), e275–e444.

6 Odutayo, A. et al (2016). Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ (Clinical research ed.), 354, i4482.

7 Natale, A. et al (2014). Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. Journal of the American College of Cardiology, 64(7), 647–656.

August 7, 2023 —  Movano Health, a purpose-driven healthcare solutions company at the intersection of medical and consumer devices and makers of the Evie Ring, announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the Company’s first commercial product, the Evie Ring. The submission has passed the first milestone of the review process, an initial review for completeness, and is now under full review by the FDA.

One of the most critical components of the FDA submission is the ring’s clinical performance. In Q4 2022, Movano Health completed a successful pivotal hypoxia trial with the University of California, San Francisco (UCSF) to assess the accuracy of Evie’s blood oxygen saturation (SpO2). In comparing the overall accuracy of the ring's data with data from arterial blood gas data, the Evie Ring achieved an approximate 2% margin of error, well below the FDA guidance of 3.5% for SpO2. In a separate nonclinical test completed by Movano Health per the standard and FDA guidance, pulse was tested over the range of 40 to 240 beats per minute (BPM) and the Evie Ring margin of error was 1 BPM, also exceeding FDA’s requirements.   

"From the outset, our vision for Evie has been to develop a consumer wearable that is beautiful, accessible and personalized, as well as be cleared by the FDA as a medical device. This first submission to the FDA marks a momentous milestone for our team and sets the stage for future FDA filings," said John Mastrototaro, CEO of Movano Health.  “The effort associated with becoming a medical device company is certainly significant, but we believe it’s a highly competitive differentiator and a strong asset when compared to existing wellness solutions. It also is expected to enable significant partnership opportunities with healthcare and other enterprises. We look forward to working with the FDA through the review process.” 

The Evie Ring combines health and wellness metrics to give a full picture of one's health: resting heart rate, heart rate variability, SpO2, respiration rate, skin temperature variability, period and ovulation tracking, menstrual symptom tracking, activity profile, including steps, active minutes and calories burned, sleep stages and duration, and mood tracking. This data is delivered through a mobile app which aims to simplify how data is presented, moving away from complex graphs and charts, and turning biometric data into actionable insights that will help women make manageable lifestyle changes and take a more proactive approach to mitigating the risks of chronic disease. 

For more information: www.movanohealth.com/

November 9, 2023 — According to a recent survey of healthcare providers (HCPs), 93 percent of clinicians are currently using RPM technologies across all cardiac rehab, marking a significant integration of technological advancements in the healthcare sector. The survey, conducted by Vivalink, a leading provider of digital healthcare solutions, focused on the adoption and impact of remote patient monitoring (RPM) technologies in both clinic and home-based rehab environments and revealed several key insights into the growing trend of home-based care. For example, 68 percent of clinicians reported having conducted some level of home-based cardiac rehab, with 29 percent conducting more or the same amount of home-based versus clinic-based, emphasizing the increasing preference for a remote care setting. 

Additional key insights from the survey include: 

• 57 percent of clinicians indicated adoption of RPM in home-based cardiac rehab within the last two years, demonstrating a recent surge in the utilization of RPM technology, post-pandemic.  
• 56 percent of clinicians prefer home-based cardiac rehab over clinic-based alternatives, indicating a shift in patient care preference.  
• 53 percent of clinicians observed an increase in patient adherence since integrating, showcasing the potential of remote care in improving patient engagement and outcomes.  
• Post myocardial infarction, commonly known as a heart attack, emerged as the primary driver for home-based cardiac rehab, underscoring the importance of remote care in managing critical cardiac conditions.  

“These insights highlight the indispensable role of RPM technologies in transforming the landscape of cardiac rehabilitation,” says Jiang Li, CEO of Vivalink. “By revolutionizing the way we approach patient care, this industry shift is poised to improve patient outcomes while reducing the strain on healthcare systems and fostering a more sustainable and patient-centric approach to cardiac health.”  

RPM’s role in healthcare is evolving and becoming more prevalent, creating patient-centered, accessible and cost-effective care. As Vivalink continues to pioneer digital healthcare solutions, it remains dedicated to providing innovative programs and products that cater to the evolving needs of healthcare providers and patients.  

For more information: www.vivalink.com