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

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

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

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

Signal HF AI
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Implicity Earns FDA Clearance for New Heart Failure Prediction Algorithm

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

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.

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New Study Shows Algorithm Highly Effective at Identifying Patterns and Classifying AF Episodes.

New Study Shows Algorithm Highly Effective at Identifying Patterns and Classifying AF Episodes. Cambridge, Mass., October 24, 2023 – Implicity, a leader in remote patient monitoring (RPM) and cardiac data management solutions, today announced the results of a clinical study published in the Cardiovascular Digital Health Journal. The findings show Implicity’s proprietary algorithm significantly reduced the number of alerts related to transmissions by cardiac implantable electronic devices (CIEDs) in patients being remotely monitored for atrial fibrillation (AF) by filtering standard device notifications and automatically classifying episodes that meet the threshold for clinical relevance. “For a patient with AF who is already anticoagulated, a single AF episode isn’t as important as established patterns or occurrences associated with arrhythmia progression and patient outcomes. This study proved Implicity’s algorithm can reduce AF alert fatigue by effectively detecting trends, both positive and negative, and categorizing events that require intervention or adjustments in treatment,” said Jagmeet P. Singh MD MMSc DPhil The retrospective study analyzed real-life data from more than 4,000 recipients of Abbott, Biotronik, Boston Scientific, or Medtronic CIED who were being continuously monitored for AF. Implicity compared the incidence of standard CIED-transmitted alerts from device manufacturers with the incidence of events detected after filtering by Implicity’s algorithm. Results showed the algorithm broke down 67,883 AF burden-related alerts into 9,728 (14.3%) clinically relevant AF events, according to the European Society of Cardiology classification. Notably, the median number of alerts per patient year decreased by 57.9%. “Sending physicians only clinically relevant alerts, based on the detection of distinct presentations of AF, can reduce the time electrophysiologists spend reviewing notifications that don’t require action by several hours. This will increase the efficiency and quality of care of patients with AF, save time for the medical staff, and help promote the adoption of RPM – leading to more meaningful remote monitoring and ultimately better outcomes,” said Dr. Arnaud Rosier, electrophysiologist, CEO, and co-founder of Implicity. Continuous remote monitoring is critical for properly managing patients with AF. It allows providers to track patients’ heart rhythms for early intervention and treatment, reducing complications such as stroke and heart failure. Yet a previous study published in European Heart Journal showed that atrial arrhythmia episodes account to up to 51% of the events clinicians are expected to review, suggesting that tackling these alerts could significantly reduce the alert burden. Implicity’s algorithm works with any device that collects atrial burden trends data and can classify the following scenarios in line with ESC recommendations: Paroxysmal AF Persistent AF Increasing paroxysmal AF Back to sinus rhythm Back to paroxysmal AF 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. To learn more, visit www.implicity.com*CE marked class I medical device (MDD); 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.  

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Implicity Expands Senior Leadership Team with New U.S. Chief Commercial Officer

Implicity Expands Senior Leadership Team with New U.S. Chief Commercial Officer Cambridge, Mass., September 27, 2023 – Implicity®, a leader in remote patient monitoring and cardiac data management solutions, announced that Jon Hunt, PhD., has joined the company as its new Chief Commercial Officer (CCO) in North America. In this role, Hunt will focus on business and sales strategies for the U.S. market to maximize growth, scale operations, and support technological innovations that help meet the growing demand for remote cardiac monitoring. Hunt brings nearly four decades of experience in the cardiovascular medical device industry. Most recently, Hunt served as Executive Vice President and Chief Business Officer at HeartBeam (NASDAQ: BEAT), a cardiac technology company that developed the first 3D vector ECG platform for heart attack detection. As a vital member of the senior leadership team, he played a critical role in taking the company public. Prior to HeartBeam, Hunt held multiple leadership positions at organizations such as the Medical Device Innovation Consortium (MDIC), Cryterion Medical, and Cameron Health. In addition, he served as President and CEO of Bardy Diagnostics,  whose novel ECG monitoring system achieved US and European approval under his leadership.  Hunt began his career with Cardiac Pacemakers (now Boston Scientific Corporation) as the Director of Clinical Programs. “Having an executive of Jon’s caliber and experience is key to achieving our goal of becoming the leader in remote cardiac monitoring in the US market.  Jon brings extensive experience in the CRM/EP market and a proven track record of scaling startup companies and building commercial teams. We look forward to his guidance and expertise as we continue to build on our successes and provide healthcare professionals nationwide with more effective solutions for managing heart disease,” said Dr. Arnaud Rosier, electrophysiologist, CEO, and founder of Implicity. Hunt joins Implicity as the company hits several critical business inflection points. Implicity recently submitted for US FDA clearance for a machine learning algorithm that can predict acute heart failure, the world’s leading cause of hospitalization. In May, Implicity revealed ground-breaking research demonstrating its AI-powered solutions significantly improve outcomes for patients with cardiac implantable devices. This as the U.S. market for remote patient monitoring has experienced significant growth. According to recent reports, the industry is expected to reach a value of more than $25 billion by 2028. “I could not be more excited to join the Implicity team at this important juncture,” said Hunt. “I’ve witnessed firsthand the healthcare ecosystem’s need for innovative solutions that can enable providers to monitor remote cardiac devices more effectively and analyze massive volumes of cardiac data more efficiently. The company and its AI-powered technology are poised to revolutionize cardiology care delivery and improve the lives of millions of people around the globe.” About Implicity Implicity is a digital MedTech software company that provides the best remote care to patients with cardiac implantable electronic devices and heart failure. Co-founded by Cardiac Electrophysiologist Arnaud Rosier, MD, Ph.D., the platform aggregates, normalizes, and standardizes data from any implantable cardiac device across all manufacturers, improving care for patients with cardiac implants. 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. To learn more, visit www.implicity.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.

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Implicity CEO Selected to Participate in HRX 2023 Panel Discussion on AI

Implicity CEO Selected to Participate in HRX 2023 Panel Discussion on AI Cambridge, Mass., September 18, 2023 – Implicity, a leader in remote patient monitoring (RPM) and cardiac data management solutions, announced today that founder and CEO Arnaud Rosier, MD, PhD, has been selected to participate in a panel discussion at the upcoming HRX 2023 Digital Health Event in Seattle, WA. The discussion, AI-aided Remote Interventions – Will this Transform Healthcare Delivery & Outcomes, takes place September 22, 2023, at 2:30 pm (PDT). As part of the discussion, Dr. Rosier intends to share insights on new international recommendations for remote monitoring of cardiovascular implantable devices (CIED) released at Heart Rhythm 2023 (HRS). The expert consensus validated the benefits of using third-party service and solution providers, such as Implicity, to ensure the highest standard of remote monitoring and improve patient outcomes. “We recently published groundbreaking data that demonstrated our AI-powered cardiac remote monitoring technology saves lives and significantly improves health outcomes,” said Dr. Rosier, Electrophysiologist, CEO, and co-founder of Implicity. “I’m eager to join experts on this panel to explore key takeaways from the research and discuss how intelligent technologies can impact our healthcare system for the better now and into the future.” Research unveiled at Heart Rhythm 2023 and led by Dr. Niraj Varma, a Professor of Medicine and consultant Electrophysiologist at the Cleveland Clinic, found patients monitored with Implicity’s alert-based platform experienced a remarkable 22% relative improvement in all-cause mortality compared to conventional RM methods. In addition to taking part in the panel presentation, Implicity also plans to exhibit at the HRX 2023 event (Booth #704) to showcase its latest innovations and technology advancements. The remote monitoring platform incorporates AI and machine learning to enable fast and effective analysis and reporting of patient results collected by CIEDs. About Implicity Implicity is a digital MedTech software company that provides the best remote care to patients with cardiac implantable electronic devices and heart failure. Co-founded by cardiac electrophysiologist Arnaud Rosier, MD, Ph.D., the platform aggregates, normalizes, and standardizes data from any implantable cardiac device across all manufacturers, improving care for patients with cardiac implants. 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. To learn more, visit www.implicity.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. For more information or to schedule a meeting, visit Implicity

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Implicity Study Presented in Late-Breaking Clinical Trial Session at Heart Rhythm 2023

Implicity Study Presented in Late-Breaking Clinical Trial Session at Heart Rhythm 2023 Cambridge, Mass., May 22, 2023 – Implicity, a leader in remote patient monitoring and cardiac data management solutions, announced the findings of a study presented during a late-breaking clinical trial session at the Heart Rhythm Society’s (HRS) annual meeting. The research was conducted in collaboration with the French government’s Health Data Hub, using a nationwide database of health information from more than 68,000 patients. Implicity linked real-world data from patients with cardiac implantable electronic devices (CIEDs) to various remote monitoring (RM) methods, comparing differences in mortality rates, number of annual hospitalizations per patient, and cumulative duration of hospital stays in a year. The results showed significant disparities in mortality rates based on the method of RM utilized. While all patients with RM experienced improved survival rates, Implicity’s universal, alert-based remote monitoring platform was associated with a greater performance compared to historical manufacturers’ solutions (Abbott, Boston Scientific, Medtronic). Notably, patients monitored with Implicity’s platform experienced a remarkable 22% relative improvement in all-cause mortality when compared with conventional RM methods, even after adjusting for confounding factors such as age, gender, CIED type, year of implant and center size. Additionally, the study revealed a significant reduction in both the number of annual hospitalizations per patient (-4%) and cumulative duration of hospital stay within a year (-6%), further validating that alert-based systems like Implicity’s can lead to superior patient outcomes in cardiac care. “We already know that remote patient monitoring saves lives. What data from this study shows is that clinical improvements vary a lot depending on how remote monitoring is performed. We saw significant improvement in mortality rates but also a decrease in hospitalizations when clinicians were supported by the Implicity platform rather than device manufacturer systems alone. This shows that the most committed teams with the best tools have the potential to achieve a better outcome for these patients. What’s remarkable is that these results occurred even before we launched our unique AI algorithms, so we can hope for even better results down the road.” said Implicity CEO and co-founder, Arnaud Rosier, MD, PhD. For more information, visit: www.implicity.com About Implicity Implicity is a digital MedTech software company dedicated to providing the best remote care to patients with connected cardiac implantable electronic devices. Co-founded by cardiac electrophysiologist Arnaud Rosier, MD, PhD, our 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 80,000 patients in over 150 medical facilities across the US and Europe. To learn more, visit www.implicity.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. Original abstract results can be found here. Differences in results are due to methodological adjustments.

Inlink - pictures
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Implicity Simplifies In-Clinic Cardiac RPM Workflows with New InLink Solution

Implicity Simplifies In-Clinic Cardiac RPM Workflows with New InLink Solution In-clinic tool automatically and securely links manufacturer programmers with Implicity’s data management solution for faster, more efficient remote monitoring workflows Cambridge, Mass., April 18, 2023 – Implicity, a leader in remote patient monitoring and cardiac data management solutions, introduced the immediate availability of InLink, a new in-clinic tool that streamlines remote cardiac monitoring workflows. Rather than having to use a USB thumb drive, InLink enables fast, secure wireless connections between the manufacturer programming systems for various cardiac implantable electronic devices (CIEDs) and the Implicity platform – making data exchanges faster, safer and more efficient. “InLink provides direct access to data and diagnostics collected by manufacturer programming systems during in-clinic device checks, eliminating the need for cumbersome manual data transfers and reducing security risks posed by USBs, such as ransomware. The transmissions now happen automatically, saving clinicians valuable time they can dedicate back to patient care,” said Ad́élie Cerrato, Product Manager at Implicity. Cardiology practices must provide routine in-clinic checks for patients with CIEDs (e.g., pacemakers, ILRs, defibrillators). During visits, remote patient monitoring (RPM) devices are interrogated by manufacturer programming systems (Medtronic, Boston Scientific, Abbott, Biotronik, Microport) to retrieve discrete data and diagnostic reports, test the device, and make necessary setting adjustments. All of that information then needs to be transferred into Implicity’s cardiac remote monitoring software or electronic medical record (EMR) systems. Previously, the reports had to be printed or downloaded onto a portable USB thumb drive. InLink modernizes this tedious process by allowing the systems to communicate and transfer data automatically. What’s more, InLink makes it easy to create in-clinic reports and access manufacturer PDFs at the end of each patient visit. “When you consider some cardiac clinics seeing over 50 patients daily, the benefits of InLink are substantial. The tool will easily save clinicians hours each week and liberate them from manual, repetitive tasks,” added Dr. Arnaud Rosier, CEO, and founder of Implicity. “This is yet another example of Implicity delivering innovative, practical solutions that help unify RPM workflows, improve the lives of clinicians and enable better, more effective cardiac care.” About ImplicityImplicity is a MedTech software company dedicated to providing the best remote care to patients with connected cardiac implantable electronic devices. Co-founded by cardiac electrophysiologist Arnaud Rosier, MD, our platform aggregates, normalizes, and standardizes data from any implantable cardiac device across all manufacturers, improving care for those with chronic heart failure conditions. As the first and only cardiac implant remote monitoring company to receive FDA clearance for an AI-based algorithm, Implicity’s platform provides critical health information, 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 80,000 patients in over 150 medical facilities across the US and Europe. To learn more, visit wwww.implicity.com Implicity®, Inc., is a Delaware corporation with offices located at 185 Alewife Brook Pkwy 210, Cambridge, MA 02138 USA, file number 5917973. * 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.

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Implicity Introduces New Algorithm to Address Alert Fatigue in AF Care

Implicity Introduces New Algorithm to Address Alert Fatigue in AF Care New feature tackles atrial fibrillation burden, reducing the alerts for patients being treated with anticoagulant medication and highlighting clinically significant events. Cambridge, Mass., April 12, 2023 – Implicity, a leader in remote patient monitoring and cardiac data management solutions, introduced a new algorithm designed to reduce alert fatigue in the remote monitoring of patients with atrial fibrillation (AF). Implicity’s AF Alert Management feature addresses AF burden, reducing alerts for patients who are taking anticoagulants and have a low risk of complications while triggering notifications the relevant moment there is a significant change in a patient’s condition that requires intervention or adjustments to treatment. “The AF Alert Management tool optimizes AFib burden management, allowing providers to focus on clinically significant events,” said Adélie Cerrato, Product Manager at Implicity. “AFib burden can vary greatly between individuals on anticoagulants or those who are not. Our new algorithm can differentiate between the two, quieting alerts associated with patients on medication and notifying providers with smart alerts when the burden exceeds the threshold for action. This, in turn, can lead to better patient outcomes as they receive appropriate care when needed.” Continuous remote monitoring is critical for properly managing patients with AF. It allows providers to track patients’ heart rhythms for early intervention and treatment, reducing complications such as stroke and heart failure. The AF burden rate, or percentage of time spent in an irregular heartbeat state, is measured using various devices, such as Holter monitors, pacemakers, defibrillators, and implantable loop recorders (ILRs). Implicity’s algorithm works with any device that collects atrial burden trends data and can classify the following scenarios in line with ESC recommendations: Consider proposing therapies to the patient, such as ablation: Paroxysmal AF Increasing paroxysmal AF Persistent AF Evaluates the success of therapies: Back to sinus rhythm Back to paroxysmal AF On average, cardiologists receive about 1,000 manufacturer’s alerts on atrial burden/month per every 1,000 patients. Reviewing these alerts manually can prove to be time-consuming and inefficient. Implicity’s AF Alert Management alleviates this pain point and has the potential to save hours of time each month, freeing up clinicians so they can focus on patient care. About ImplicityImplicity is a MedTech software company dedicated to providing the best remote care to patients with connected cardiac implantable electronic devices. Co-founded by cardiac electrophysiologist Arnaud Rosier, MD, our platform aggregates, normalizes, and standardizes data from any implantable cardiac device across all manufacturers, improving care for those with chronic heart failure conditions. As the first and only cardiac implant remote monitoring company to receive FDA clearance for an AI-based algorithm, Implicity’s platform provides critical health information, 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 80,000 patients in over 150 medical facilities across the US and Europe. To learn more, visit www.implicity.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.