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Study Shows Implicity’s New Agnostic Cloud-Based AI Algorithm Further Reduces False Alerts Even After Manufacturer AI Filtering in Modern Devices

Alexandre Mathieu / April 25, 2026

Study Shows Implicity’s New Agnostic Cloud-Based AI Algorithm Further Reduces False Alerts Even After Manufacturer AI Filtering in Modern Devices New HRS data extends EHRA findings with a specific analysis of next-gen ILRs, demonstrating that, on top of manufacturer-embedded AI, Implicity filters out 61.6% of false positives while maintaining 98.3% sensitivity Cambridge, Mass., April 25, 2026 – Implicity, a leader in remote patient monitoring and cardiac data management solutions, today announced the latest findings presented at the Heart Rhythm Society (HRS) 2026. The new HRS data extends on research presented earlier this month at the European Heart Rhythm Association (EHRA) Congress, which showed why false-positive alerts persist even in modern implantable loop recorders (ILRs). The follow-on HRS study specifically focused on the latest AI-equipped ILRs, examining whether layering Implicity’s new, universal cloud-based AI algorithm on top of proprietary manufacturer algorithms could further reduce false alerts. In a review of 483 cases from 324 patients using AI-equipped devices, Implicity’s next-generation ILR ECG Analyzer successfully reclassified 61.6% of false-positive alerts in interpretable episodes while maintaining 98.3% sensitivity, helping reduce the workload for clinicians without compromising patient safety. “Manufacturer filtering has clearly advanced, whether it happens in the device, in the cloud, or through a combination of both. But even in these newer systems, residual false-positive alerts still remain and continue to burden clinical teams. The findings from our HRS study demonstrate that a manufacturer-agnostic analysis layer can substantially reduce that remaining noise while maintaining the high sensitivity needed to protect patient safety,” said Arnaud Rosier, MD, PhD, electrophysiologist, CEO, and co-founder of Implicity. Implicity’s next-generation ILR ECG Analyzer is designed to act as an agnostic second-layer for residual alerts that remain after the initial manufacturer filters. Operating in the cloud and compatible with all major brands, Implicity’s new universal algorithm applies the most sophisticated neural networks, drastically reducing false positives without compromising patient safety. This ‘dual AI‘ approach does more than just streamline remote cardiac monitoring workflows; it also reduces alert fatigue by providing clinical teams with highly accurate, trustworthy data. With greater confidence in the data, clinicians can spend less time on noise and more time focusing on meaningful cardiac events. “Newer AI-enabled ILRs do provide a cleaner data stream with fewer obvious artifacts, but they are not perfect, and the false positives that remain are often more subtle and clinically ambiguous,” said Niraj Varma, MD, PhD, Professor of Medicine and Consultant Electrophysiologist at the Cleveland Clinic. “Those are exactly the alerts that still require careful adjudication. In a remote monitoring workflow, that matters enormously, and any technology that can safely mitigate ILR-related false-positive alerts is significant.” These findings follow evidence presented at EHRA examining why false-positive alerts persist across modern ICM devices. In that work, investigators identified guideline-based interpretation gaps and signal-detection issues as key drivers of non-actionable alerts and showed that even in AI-equipped devices, 32.9% of episodes remained non-actionable, with another 30.6% deemed indeterminate. Together, the EHRA and HRS analyses highlight both the mechanisms behind persistent false positives and the potential for a universal, , cloud-based AI approach to help address them across all devices—including those with or without proprietary AI. . Implicity’s next-generation ILR ECG Analyzer Algorithm (V2) is not FDA cleared yet. About ImplicityImplicity is a digital MedTech software company dedicated to providing the best remote care to patients with cardiac implantable electronic devices and heart failure. Co-founded by cardiac electrophysiologist Arnaud Rosier, MD, PhD, the platform aggregates, normalizes, and standardizes data from any implantable cardiac device across all manufacturers, improving care for patients with cardiac implants and heart failure. Implicity’s platform provides critical health information augmented by FDA-cleared AI** algorithms, enabling healthcare providers to make more informed decisions for better patient outcomes while optimizing workflows. With access to the Health Data Hub—a gateway to one of the world’s largest databases of heart disease patients encompassing nearly the entire French cardiac patient population—Implicity is able to develop its AI solutions based on more robust data. The company is protecting more than 110,000 patients in over 250 medical facilities across the US and Europe. To learn more, visit www.implicity.com or schedule a meeting with the Implicity team. Contact Daniel Martin, Vice President for US Sales, at daniel.martin@implicity.com or visit Booth #1819 at HRS 2026. Health Data Hub is a health data platform established by the French government to combine existing health patient databases and facilitate their usage for research and development purposes * The version of ILR ECG Analyzer evaluated in this study (V2) is not yet FDA cleared. Results may not be directly applicable to the currently cleared version ** SignalHF is an FDA-cleared Class II medical device, see the instructions for use for more information. IM007 ILR ECG Analyzer is an FDA cleared Class II medical device and CE marked Class I (under MDD) medical device, see the instructions for use for more information. IMPLICITY®, Inc. a Delaware corporation with offices located at 185 Alewife Brook Pkwy 210, Cambridge, MA 02138 USA, file number 5917973. Media Contact: Samantha Choinski eMedia Junction samantha@emediajunction.com ¹IM009: 2021. Manufacturer: Implicity. IM009 is a software as a medical device (SaMD) intended to be used as an adjunct of a remote monitoring platform to follow-up target population patients. IM009 is compatible with devices with remote monitoring feature such as cardiac implantable electronic devices and connected weight scales. The three main intents of IM009 are to (1) label observations generated by medical devices according to predefined categories, (2) create clinically relevant observations for worsening atrial fibrillation and/or rapid weight gain in the context of heart failure, based on data recorded by the device and (3) label Atrial Fibrillation burden observations generated by cardiac implantable electronic device (CIED) as to be hidden or relevant for health care provider based on patient’s anticoagulation status. Hence, IM009 is designed to reduce the workload burden of healthcare providers/professionals in charge of reviewing the observations received from the patients’ devices. IM009 is not intended for use in life supporting or sustaining systems or Alarm devices and as a

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EHRA 2026 Studies Reveal Why False Positives Persist in AI-Equipped Implantable Cardiac Monitors

Alexandre Mathieu / April 14, 2026

EHRA 2026 Studies Reveal Why False Positives Persist in AI-Equipped Implantable Cardiac Monitors Research identifies guideline-based interpretation gaps and signal-detection issues behind non-actionable alerts and shows how an additional cloud-based AI layer can significantly reduce clinician review burden while maintaining high sensitivity Cambridge, Mass., April 14, 2026 – Implicity, a leader in remote patient monitoring and cardiac data management solutions, today revealed new research presented at the 2026 European Heart Rhythm Association Congress (EHRA) examining why false-positive alerts remain a persistent challenge in implantable cardiac monitors (ICMs)—even in devices equipped with manufacturer AI algorithms. While physicians experience this burden every day, the findings provide new insight into why it persists, identifying guideline-based interpretation gaps and signal-detection issues as key drivers of non-actionable alerts across modern ICM platforms. In a cross-manufacturer analysis of 2,659 rhythm episodes from 1,710 patients implanted with ICMs from Medtronic, Biotronik, Abbott, and Boston Scientific, findings revealed that even in AI-equipped devices, 32.9% of episodes were still non-actionable, with another 30.6% deemed indeterminate. Among devices without proprietary AI algorithms, 45.4% of episodes were non-actionable and 20.1% indeterminate. To conduct the analysis, an independent expert adjudication committee applied a standardized annotation framework aligned with international electrophysiology guidelines to determine whether device-detected episodes met the diagnostic criteria for clinically meaningful arrhythmias. The findings provide new insight into why false-positive alerts persist even as device algorithms have evolved. Investigators found that many alerts stem from how device algorithms interpret rhythm signals relative to guideline-defined arrhythmia criteria. When those interpretations diverge from clinical definitions, benign rhythms or signal artifacts, such as premature ventricular contractions or electrical noise, may be labeled as clinically significant events. The analysis also identified specific signal-detection mechanisms contributing to these alerts. Episodes labeled as cardiac “pause” events emerged as a major driver, with 46.8% ultimately determined to be false positives caused by R-wave undersensing, where the device fails to detect a heartbeat and incorrectly interprets the signal as a pause. “False-positive alerts remain one of the biggest operational challenges in remote cardiac monitoring,” said Niraj Varma, MD, PhD, Professor of Medicine and Consultant Electrophysiologist at the Cleveland Clinic. “Every episode flagged by an implantable cardiac monitor must be reviewed by a clinician, yet even devices equipped with manufacturer AI algorithms still generate a substantial number of non-actionable alerts. When interpretation varies across device platforms and guideline definitions are not consistently applied, it becomes more difficult for physicians to quickly determine which events truly require clinical attention.” Building on these findings, investigators conducted a second analysis, also presented at EHRA, to examine whether an additional AI layer could help address these persistent false-positive alerts. The study evaluated the Implicity™ ILR ECG Analyzer*, a cloud-based algorithm designed to analyze ICM transmissions across multiple manufacturer platforms using a standardized guideline-based framework. The results showed that Implicity’s cloud-based AI algorithm maintained very high sensitivity for detecting clinically meaningful arrhythmias—98.3% in AI-equipped devices and 94.3% in non-AI models—while filtering a substantial proportion of non-actionable alerts. Specificity reached 61.6% and 75.6% respectively, with a consistent positive predictive value of approximately 74% across both groups, demonstrating reliable diagnostic performance across different generations of implantable cardiac monitors. “Remote monitoring only works if clinicians can trust the alerts they receive,” said Arnaud Rosier, MD, PhD, electrophysiologist, CEO, and co-founder of Implicity. “When a large share of those alerts are non-actionable, the burden is not just operational—it diverts valuable clinical time from patients who may truly need attention. Our data shows that adding a standardized, guideline-based AI layer can reduce that noise while maintaining the high sensitivity needed to detect clinically meaningful arrhythmias.” The research presented at EHRA is part of Implicity’s broader clinical program focused on improving the accuracy and efficiency of remote cardiac monitoring. Additional data will be presented at the Heart Rhythm Society (HRS) Scientific Sessions, April 23–26, 2026, in Chicago. To schedule a meeting with the Implicity team, contact Daniel Martin, Vice President for US Sales, at daniel.martin@implicity.com or visit Booth #1819 at HRS 2026. About ImplicityImplicity is a digital MedTech software company dedicated to providing the best remote care to patients with cardiac implantable electronic devices and heart failure. Co-founded by cardiac electrophysiologist Arnaud Rosier, MD, PhD, the platform aggregates, normalizes, and standardizes data from any implantable cardiac device across all manufacturers, improving care for patients with cardiac implants and heart failure. Implicity’s platform provides critical health information augmented by FDA-cleared AI³ algorithms, enabling healthcare providers to make more informed decisions for better patient outcomes while optimizing workflows. With access to the Health Data Hub, one of the world’s largest databases of heart disease patients, Implicity is able to develop its AI solutions based on more robust data. The company is protecting more than 110,000 patients in over 250 medical facilities across the US and Europe. To learn more, visit www.implicity.com Media Contact: Samantha Choinski eMedia Junction samantha@emediajunction.com Health Data Hub is a health data platform established by the French government to combine existing health patient databases and facilitate their usage for research and development purposes * The version of ILR ECG Analyzer evaluated in this study (V2) is not yet FDA cleared. Results may not be directly applicable to the currently cleared version

Editorial Press

EVIDENCE-RM: A revealing study on the medical-economic impact of remote cardiac monitoring

Delphine LEFEBVRE / April 30, 2025

EVIDENCE-RM: A revealing study on the medical-economic impact of remote cardiac monitoring In a health expenditure framework, the question of the relative cost-effectiveness ratio of new medical technologies is essential. The EVIDENCE-RM retrospective study, conducted by Implicity, provided concrete elements on the medical-economic impact of remote monitoring for patients with implantable cardiac defibrillators (ICDs). A comparison between remote monitoring systems The aim of the study was to compare healthcare costs between Implicity’s universal remote monitoring platform, independent of the ICD manufacturer, and conventional solutions offered by the manufacturers. Data from patients monitored via the Implicity platform in 2019 was cross-referenced with the French National Health Data System (SNDS) database, the analysis highlighted significant differences between care costs for patients monitored with the Implicity platform versus manufacturer’s solutions. Significant savings The study demonstrates that patients monitored on the IMPLICITY IM009¹ universal remote monitoring platform showed² : A 4% reduction in overall healthcare costs A 17.8% decrease in hospital costs, mainly due to the reduction in cardiovascular care expenditure A 7.9% increase in outpatient care costs, illustrating more proactive management Furthermore, Implicity’s universal platform demonstrated a negative incremental cost-effectiveness ratio of -€103 per day of life outside of hospital, indicating patients are spending more time outside of hospital while generating cost savings. A beneficial preventive approach These results indicate the Implicity platform facilitates better anticipation of complications and more effective preventive management, thereby reducing hospitalizations and associated costs. The adoption of universal and independent solutions could therefore constitute an interesting way to optimize health expenditure while improving the quality of care. ¹IM009: 2021. Manufacturer: Implicity. IM009 is a software as a medical device (SaMD) intended to be used as an adjunct of a remote monitoring platform to follow-up target population patients. IM009 is compatible with devices with remote monitoring feature such as cardiac implantable electronic devices and connected weight scales. The three main intents of IM009 are to (1) label observations generated by medical devices according to predefined categories, (2) create clinically relevant observations for worsening atrial fibrillation and/or rapid weight gain in the context of heart failure, based on data recorded by the device and (3) label Atrial Fibrillation burden observations generated by cardiac implantable electronic device (CIED) as to be hidden or relevant for health care provider based on patient’s anticoagulation status. Hence, IM009 is designed to reduce the workload burden of healthcare providers/professionals in charge of reviewing the observations received from the patients’ devices. IM009 is not intended for use in life supporting or sustaining systems or Alarm devices and as a solely means of diagnosis. It is offered to healthcare providers/professionals on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. Class I, according to Medical Device Directive 93/42/EEC. See the instructions for use for more information. Covered under the conditions defined in Article L. 162-52 of the French Social Security Code.²E. Marijon. Cost impact of the use of a universal cardiac implantable electronic devices remote monitoring solution: results of the EVIDENCE RM study. Poster presentation : European Society of Cardiology 2024; London. Implicity is a unique platform that aggregates and processes data from cardiac implantable electronic devices (CIEDs) and weight scales. This integration particularly benefits many heart failure patients who rely on CIEDs. By centralizing all relevant data on one platform, Implicity streamlines the management of a patient’s clinical situation, enhancing efficiency and clarity for healthcare providers. This consolidation allows patients to receive personalized support tailored to their specific needs, directly contributing to an improved quality of life from the comfort and safety of their homes. Through the Implicity Heart Failure platform, physicians are equipped with a dynamic solution, enabling proactive management of patient health progression. This approach not only facilitates the avoidance of hospital admissions but also addresses the need to control healthcare expenses efficiently. *Not currently available in the United States

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Implicity’s EVIDENCE-RM Study Demonstrates Marked Improvement in ICD Patient Outcomes

Delphine LEFEBVRE / April 24, 2025

Implicity’s EVIDENCE-RM Study Demonstrates Marked Improvement in ICD Patient Outcomes Comprehensive analysis of real-world data shows significant clinical and medico-economic advantages of Implicity’s universal, alert-based remote monitoring platform. Cambridge, Mass., April 24, 2025 – IMPLICITY®, a leader in remote patient monitoring and cardiac data management solutions, today unveiled new findings from its EVIDENCE-RM study¹. Leveraging extensive data from the French National Health Data System (SNDS), the study demonstrated clear clinical and medico-economic benefits associated with Implicity’s universal monitoring system (UMS) compared to conventional, manufacturer-specific systems, including Abbott, Biotronik, Boston Scientific, and Medtronic. The study, recently published in Heart Rhythm, analyzed clinical outcomes and costs for over 69,000 patients with implantable cardioverter-defibrillators (ICDs) and defibrillators with cardiac resynchronization therapy (CRT-Ds). Patients remotely monitored using Implicity’s platform showed increased survival rates and a reduction in both the number and duration of all-cause and heart failure-related hospitalizations, resulting in substantial healthcare cost reductions. Key findings attributed to Implicity’s IM009² platform include: 26% reduction in mortality (HR, 0.74; 95% CI, 0.73–0.77; P=.001) 4% decrease in HF hospitalizations, total corrected healthcare costs, and mean duration of hospitalization 8% decrease in hospital-related costs, primarily driven by decreased costs in cardiovascular disease care Incremental Cost-Effectiveness Ratio (ICER) of approximately -$112 USD (-103€) per Day Alive and Out of Hospital (DAOH) based on the French Healthcare System “Managing patients with ICDs and CRTs presents considerable challenges, since they are at high risk of hospitalization due to arrhythmias and heart failure, » said Dr. Niraj Varma, Professor of Medicine and Director, Cardiac Pacing & Tachyarrhythmia Devices at the Cleveland Clinic. « The EVIDENCE-RM study clearly demonstrates that a universal monitoring solution operating alert-based remote monitoring can significantly reduce these risks, improving patient outcomes and substantially lowering healthcare costs. This is an important advancement in our ability to proactively manage patients with ICDs and CRTs.” « These findings mark a pivotal moment in remote cardiac care and prove Implicity’s effectiveness with unparalleled clinical results, » stated Implicity CEO Dr. Arnaud Rosier. « A 26% reduction in mortality and better use of healthcare resources highlight the impact of universal remote monitoring, driven by AI, over fragmented manufacturer-specific systems. Implicity is committed to driving innovation so that every cardiac patient receives proactive, efficient care.” About Implicity Implicity is a digital MedTech software company dedicated to providing the best remote care to patients with cardiac implantable electronic devices and heart failure. Co-founded by cardiac electrophysiologist Arnaud Rosier, MD, PhD, the platform aggregates, normalizes, and standardizes data from any implantable cardiac device across all manufacturers, improving care for patients with cardiac implants and heart failure. Implicity’s platform provides critical health information augmented by FDA-cleared AI³ algorithms, enabling healthcare providers to make more informed decisions for better patient outcomes. With access to the Health Data Hub, one of the world’s largest databases of heart disease patients, Implicity is able to develop its AI solutions based on more robust data. The company is protecting more than 100,000 patients in over 200 medical facilities across the US and Europe. Health Data Hub is a health data platform established by the French government to combine existing health patient databases and facilitate their usage for research and development purposes References Varma et al., “Impact of a universal monitoring system (‘third party’) on outcomes of ICD patients: A nationwide study,” Heart Rhythm, 2024. IM009: 2021. Manufacturer: Implicity. IM009 is a software as a medical device (SaMD) intended to be used as an adjunct of a remote monitoring platform to follow-up target population patients. IM009 is compatible with devices with remote monitoring feature such as cardiac implantable electronic devices and connected weight scales. The three main intents of IM009 are to (1) label observations generated by medical devices according to predefined categories, (2) create clinically relevant observations for worsening atrial fibrillation and/or rapid weight gain in the context of heart failure, based on data recorded by the device and (3) label Atrial Fibrillation burden observations generated by cardiac implantable electronic device (CIED) as to be hidden or relevant for health care provider based on patient’s anticoagulation status. Hence, IM009 is designed to reduce the workload burden of healthcare providers/professionals in charge of reviewing the observations received from the patients’ devices. IM009 is not intended for use in life supporting or sustaining systems or Alarm devices and as a solely means of diagnosis. It is offered to healthcare providers/professionals on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. Class I, according to Medical Device Directive 93/42/EEC. See the instructions for use for more information. Covered under the conditions defined in Article L. 162-52 of the French Social Security Code. IM007: 2021. ILR ECG ANALYZER created by Implicity is intended to be used by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data. ILR ECG ANALYZER supports downloading and analyzing data recorded in compatible formats from ICMs. This version of the ILR ECG ANALYZER only supports ECG data from Medtronic ICMs. ILR ECG ANALYZER is intended to be electronically interfaced with other computer systems (remote monitoring platforms) that supply the ECG data to ILR ECG ANALYZER and receive the output of ILR ECG ANALYZER (analysis) for viewing by healthcare professionals. ILR ECG ANALYZER provides ECG signal processing and analysis, to detect asystole, bradycardia, atrial tachycardia or atrial fibrillation, ventricular tachycardia, normal rhythm and artifacts. ILR ECG ANALYZER is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. ILR ECG ANALYZER interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. ILR ECG ANALYZER is interfaced with the compatible remote monitoring platform from which it receives compatible ICM data file input (Medtronic LNQ11 Medtronic REVEAL XT 9529 Medtronic REVEAL DX 9528) and to which it transmits the output. Read carefully all instructions

Editorial Press

Understanding AFib: AFib Awareness Month and Its Importance

Delphine LEFEBVRE / September 10, 2024

Understanding AFib: AFib Awareness Month and Its Importance September is not just about the changing seasons or the back-to-school rush; it’s also a significant month for health awareness. Among the various health observances, AFib Awareness Month stands out, dedicated to raising awareness about atrial fibrillation (AFib)—a condition that affects millions of people worldwide. Understanding AFib, its risks, and how to manage it can be lifesaving. Here’s why AFib Awareness Month is so important and what you need to know about this condition. What is AFib?Atrial fibrillation, commonly known as AFib, is the most common type of irregular heart rhythm (arrhythmia). It occurs when the upper chambers of the heart (atria) beat irregularly and out of sync with the lower chambers (ventricles). This can lead to a range of symptoms, from a fluttering heartbeat and fatigue to more serious complications like stroke and heart failure.AFib can be intermittent or persistent, and while some people may not experience noticeable symptoms, others might feel palpitations, shortness of breath, or dizziness. The erratic rhythm can cause blood to pool in the heart, leading to the formation of blood clots. If a clot travels to the brain, it can cause a stroke, making AFib a serious condition that requires medical attention.Why AFib Awareness Month MattersThe observance of AFib Awareness Month in September is crucial for several reasons: Raising Awareness: Many people are unaware that they have AFib because it can be asymptomatic or mistaken for other conditions. Awareness campaigns help educate the public about the signs and risks associated with AFib, encouraging people to seek medical advice if they experience symptoms. Promoting Early Detection: Early detection of AFib is key to preventing serious complications like stroke. During this month, healthcare providers emphasize the importance of regular check-ups, especially for those at higher risk, such as older adults or individuals with underlying health conditions like high blood pressure, diabetes, or heart disease. Highlighting Treatment Options: AFib management has evolved significantly, with a range of treatment options available, from medications to control heart rate and rhythm, to procedures like cardioversion, catheter ablation, and the use of anticoagulants to reduce stroke risk. AFib Awareness Month is an opportunity to educate patients about these options and the importance of adhering to prescribed treatments. Encouraging Lifestyle Changes: Lifestyle modifications can play a critical role in managing AFib. This includes maintaining a healthy weight, reducing alcohol consumption, quitting smoking, managing stress, and staying physically active. Public health campaigns during AFib Awareness Month often focus on these preventive measures. Supporting Research and Innovation: The month also serves as a reminder of the ongoing need for research into AFib. Advances in medical technology, such as wearable devices that monitor heart rhythms, have the potential to revolutionize how AFib is detected and managed. By supporting research initiatives, we can hope for better treatments and perhaps even a cure in the future.

Editorial Press

Exploring the 8 Key Objectives and Applications of Remote Patient Management

Delphine LEFEBVRE / August 13, 2024

Exploring the 8 Key Objectives and Applications of Remote Patient Management Remote Patient Management (RPM) is more than just a technological innovation; it’s a game-changer in how we deliver cardiovascular care. The American College of Cardiology has highlighted eight critical objectives* that illustrate the transformative potential of RPM: 1. Increased Access to Care: RPM extends medical services to remote or underserved areas, ensuring that geographical barriers no longer impede quality healthcare.2. Prolonged Monitoring: By monitoring patients over an extended period, RPM enhances diagnostic accuracy and sensitivity, enabling more informed clinical decisions.3. Early Disorder Detection: RPM captures conditions that may go unnoticed during routine visits, such as arrhythmias or masked hypertension, offering a more comprehensive view of a patient’s health.4. Early Intervention: RPM allows for the early detection of disease deterioration, enabling timely management strategies that can prevent major cardiovascular events like heart attacks or hospitalizations.5. Lifestyle Improvements: Continuous monitoring through RPM supports treatment effectiveness, guiding adjustments that can significantly improve a patient’s lifestyle and overall well-being.6. Reduced Side Effects: By closely monitoring treatment responses, RPM helps minimize side effects and complications, optimizing patient outcomes.7. Enhanced Perioperative Outcomes: RPM improves outcomes around surgeries and procedures, ensuring safer discharges and reducing the risk of complications.8. Screening High-Risk Populations: RPM is crucial for screening and identifying under-detected health conditions in high-risk populations, enabling proactive interventions. As RPM continues to evolve, its integration into cardiology practice is not just a trend but a necessity. These objectives underscore the potential of RPM to revolutionize patient care, making it more proactive, personalized, and efficient. * »Remote Patient Management Workbook, » 2024, Das et al.

Editorial Press

Revolutionizing Heart Failure Care: Introducing SignalHF AI Algorithm

Delphine LEFEBVRE / May 18, 2024

Revolutionizing Heart Failure Care: Introducing SignalHF AI Algorithm SignalHF*, an FDA-cleared AI algorithm, is becoming an essential ally for cardiac remote monitoring teams in a groundbreaking stride toward proactive healthcare management. With its capability to predict heart failure hospitalizations within 30 days, SignalHF stands at the forefront of a new era in cardiovascular care, enabling timely interventions. Heart failure, a chronic condition affecting millions globally, presents a significant burden on healthcare systems and individuals alike. Despite advancements in treatment modalities, preventing decompensations and hospitalizations remains a challenge. However, with the advent of artificial intelligence and predictive analytics, the landscape of heart failure management is undergoing a profound transformation. SignalHF, developed through rigorous research and testing, harnesses the power of machine learning to analyze diverse patient data and identify subtle patterns indicative of impending cardiac decompensations. By integrating various parameters such as physiological data, demographics, lead measurements, episodes, and therapies, SignalHF generates a comprehensive risk assessment tailored to each individual. SignalHF’s key strength lies in its proactive approach to healthcare. Rather than reacting to acute events, remote monitoring teams can intervene preemptively, potentially averting hospitalizations and improving patient outcomes. Its alert system is central to SignalHF’s functionality, which triggers notifications when a patient’s SignalHF score surpasses a predefined threshold. These alerts serve as a call to action for healthcare teams, prompting timely interventions such as medication adjustments, lifestyle modifications, or closer monitoring. By facilitating early interventions, SignalHF empowers clinicians to deliver personalized care and avoid adverse events. The launch of SignalHF heralds a new chapter in managing heart failure, characterized by proactive risk mitigation and personalized care delivery. As healthcare systems worldwide grapple with the challenges of rising chronic disease prevalence and constrained resources, innovative solutions like SignalHF are poised to transform patient care. *SignalHF is an FDA-cleared Class II medical device. See the instructions for use for more information.

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Implicity Earns FDA Clearance for New Heart Failure Prediction Algorithm

Delphine LEFEBVRE / May 17, 2024

Implicity Earns FDA Clearance for New Heart Failure Prediction Algorithm Cutting-edge tool analyzes data from cardiac remote monitoring devices to assess whether a patient is at high risk of experiencing worsening heart failure, enabling medical teams to intervene and avoid hospitalization. Cambridge, Mass., May 17, 2024 – Implicity, a leader in remote patient monitoring and cardiac data management solutions, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new groundbreaking algorithm, SignalHF*, used in its remote monitoring solution. Implicity was the first private company authorized to access the Health Data Hub, one of the largest databases of patients with heart diseases in the world. Based on the Health Data Hub complete medico-administrative database and comprehensive datasets from Implicity’s AI-based remote monitoring platform, the Implicity team trained and validated a machine learning algorithm that assesses the risk of future heart failure events, enabling physicians to intervene before a patient requires hospitalization. “Heart failure remains a significant healthcare challenge, contributing to approximately one million hospitalizations each year. Preventing even a portion of these would be a game-changer in cardiac care,” said Dr. Arnaud Rosier, Implicity’s CEO and cardiologist. “SignalHF is an innovative and effective tool that physicians can use to assess risk of hospitalization due to heart failure earlier, enabling interventions that can lead to better outcomes and reduce hospital admissions.” SignalHF is unique in that the manufacturer-agnostic solution can be used to analyze data collected from a variety of Cardiac Implantable Electronic Devices (CIED), including implantable cardiac defibrillators (ICD), pacemakers (PM) and cardiac resynchronization therapy devices (CRT-P, CRT-D) from Biotronik, Boston Scientific and Medtronic. SignalHF is the first pacemaker compatible heart failure algorithm on the market. The algorithm can accurately identify trends indicating whether a patient’s condition is worsening. Care teams receive an automatic alert when the patient’s risk score crosses an established threshold, indicating an individual is at high risk of experiencing heart failure and being hospitalized in the near future. “Comprehensive heart failure management includes treatment, prevention, and personalization. Implicity’s solution is part of this approach. Our alerts are generated in context with a patient’s medical profile to help personalize care management plans. Furthermore, 75% of the alerts preceding a patient hospitalization are sent at least 14 days in advance – offering a two-week window to adjust medications or take proactive measures,” said Issam Ibnouhsein, Head of Data at Implicity. About ImplicityImplicity provides a remote monitoring and research platform used by Independent Diagnostic Testing Facilities and cardiac electrophysiology centers to deliver better, high-quality care for their patients with Cardiac Implantable Electronic Devices. Implicity’s platform aggregates, normalizes, and standardizes data from any implantable cardiac device across all manufacturers. Furthermore, Implicity carries out R&D on AI-based algorithms aiming at improving patient care and serving the future of preventive medicine. www.implicity.com *SignalHF is an FDA-cleared Class II medical device. See the instructions for use for more information.

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Implicity Joins the AWS ISV Accelerate Program

Delphine LEFEBVRE / December 12, 2023

Implicity Joins the AWS ISV Accelerate Program Cambridge, Mass., December 12, 2023 – Implicity, a leader in remote patient monitoring and cardiac data management solutions, announced it has joined the Amazon Web Services (AWS) Independent Software Vendor (ISV) Accelerate Program, a co-sell program for AWS partners that provide software solutions that run on or integrate with AWS. The program helps AWS partners drive new business by directly connecting participating ISCs with the AWS Sales organization. “This is an important milestone that amplifies our reach and validates our mission to bring digital innovation to cardiology. By deepening our relationship with AWS, we can help even more clinicians improve cardiac care by delivering cutting-edge solutions that enable more efficient and effective remote monitoring,” said Jon Hunt, PhD., Implicity’s Chief Commercial Officer in North America. Implicity’s AI-powered* platform allows healthcare professionals to better manage the growing streams of patient information produced by cardiac implantable electronic devices (CIEDs), such as pacemakers and implanted defibrillators. The solutions can also interpret data and automatically alert care teams when intervention is required. The AWS ISV Accelerate Program provides Implicity with co-sell support that benefits to meet customer needs through collaboration with AWS field sellers globally. Co-selling provides better customer outcomes and assures mutual commitment from AWS and its partners. « Before Implicity, our team would have spent hours weeding through alerts and reports. This would have delayed the treatment of patients with clinically significant events or critical episodes. Additionally, their customer support and service have been second to none. They are truly dedicated to helping clinicians streamline their care and optimize their workflow. This system is life-changing, » said Dan Morris, Device Clinic Lead at the Heart Center of Nevada. AWS ISV Accelerate program members are held to the industry’s highest standards. To gain acceptance into the AWS ISV Accelerate Program, proof of customer excellence was required to validate the success users have experienced using the technology. Implicity also had to pass a rigorous technical and security review of its platform to ensure the quality and design of its solutions. The program gives Implicity-focused co-selling support and access to expanded sales enablement resources from AWS. It also provides technical enablement and business resources to enhance Implicity’s offerings and drive innovation. About Implicity Implicity is a digital MedTech software company dedicated to providing the best remote care to patients with cardiac implantable electronic devices and heart failure. Co-founded by cardiac electrophysiologist Arnaud Rosier, MD, PhD, the platform aggregates, normalizes, and standardizes data from any implantable cardiac device across all manufacturers, improving care for patients with cardiac implants and heart failure. Implicity’s platform provides critical health information augmented by FDA-cleared AI* algorithms, enabling healthcare providers to make more informed decisions for better patient outcomes. With access to the Health Data Hub**, one of the world’s largest databases of heart disease patients, Implicity is able to develop its AI solutions based on more robust data. The company is protecting more than 94,000 patients in over 195 medical facilities across the US and Europe. *FDA cleared Class II medical device, and CE marked Class I (under MDD) medical device; see the instructions for use for more information.**Health Data Hub is a health data platform established by the French government to combine existing health patient databases and facilitate their usage for research and development purposes.

Contributed Article Press

Expert Consensus on Remote Monitoring: Key Staffing Takeaways

Delphine LEFEBVRE / November 20, 2023

Expert Consensus on Remote Monitoring: Key Staffing Takeaways Recent recommendations for remote monitoring of implantable devices may require healthcare organizations to rethink how they staff their operations This past spring, electrophysiology experts issued new recommendations for remote monitoring of cardiovascular implantable electronic devices (CIEDs). The expert consensus statement — released jointly by four major cardiac electrophysiology societies — covers everything from patient enrollment to connectivity. More than anything, though, I was struck by the recommendations around staffing. The first “take-home message” listed in the report is that remote monitoring is the standard of care for patients with implantable cardiac devices. However, this has been the case since at least 2015, and I would estimate that only around half of patients with CIEDs are enrolled in remote monitoring programs. Even for those who are remotely monitored, service levels are highly inconsistent. I’ve heard stories of patients who have turned off their transmitters, and no one contacted them about the missing signal for weeks, simply because providers were overwhelmed or didn’t have the proper resources to track disconnected devices. This is one example of why these new staffing recommendations are so important. If we provide an aging population with the best care possible, healthcare organizations must first learn how to train and manage the employees needed to monitor remote devices effectively; or educate them on third-party resources available to help fill the gaps. The key staffing takeaways from the report include the following. Three Employees to Monitor 1,000 Patients “For the care of patients with CIEDs on [remote monitoring],” the report states, “it is reasonable for clinics to have a minimum of 3.0 full-time equivalents per 1,000 patients on [remote monitoring], comprising both clinical and administrative staff.” Now, this may not sound like an overly burdensome staffing ratio, but many healthcare organizations struggle to attract and retain staff. To meet the needs of the future — most providers will need to step up their staffing, become dramatically more efficient, or both. With a third-party tool, clinics can expand capacity without adding to their headcount. For organizations that use Implicitly, it is relatively common for a clinic to maintain only three full-time employees to manage remote monitoring for up to 5,000 or more patients. The Importance of Certification and Training Providers who oversee — or who review, manage, document or bill for remote monitoring of implantable cardiac devices — should be able to demonstrate their expertise in CIED management by holding appropriate education and certifications, the recommendations state. Further, the expert consensus holds that these education and certification efforts should be supported (i.e., funded) by employers and that all staffers involved with remote monitoring should engage in quality improvement reviews to support current evidence-based standards. Translation: It’s not enough to merely hire an appropriate number of employees. Providers must continue to train their staff on an ongoing basis. A Transition to Alert-based Monitoring For patients who lack continuous connectivity, it is recommended that they make remote transmissions every 3 to 12 months, depending on device type. However, the recommendations note that continuous connectivity allows providers to monitor patient data based on specific alerts rather than at time-based intervals. Alert-based monitoring became more common during the COVID-19 pandemic out of necessity, and it showed promising results, with the potential to make remote monitoring staffers more efficient. According to the report, alert-based monitoring “could minimize low-value effort, optimize clinic visits for actionable events, and decrease health care costs.” Read the full article here.

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