Fall 2025 - Innovation

Technological Advancements in Cardiology: Improved Monitoring

With a pending shortage of cardiologists, there is a growing need for remote cardiac monitoring, and now, three FDA-cleared products are transforming how this care is provided.

ACCORDING TO THE American Heart Association’s “2025 Heart Disease and Stroke Statistics Update: A Report of U.S. and Global Data from the American Heart Association,” heart disease has been the leading cause of death in the U.S. for 100 years.1 However, sadly in 2021, the Association of American Medical Colleges predicted a shortage of 120,000 cardiologists by 2030.2

With heart disease the leading cause of death, coupled with a projected shortage of more than 100,000 cardiologists within the next five years, innovative solutions in cardiac care are urgently needed to ensure timely and effective treatment for patients to maintain a seamless continuum of cardiac monitoring care from the hospital to home.

The Importance of Remote Cardiac Monitoring

According to Anjali B. Thakkar, MD, a member of the American College of Cardiology’s Health Care Innovation Council, near-continuous or continuous cardiac remote monitoring devices enable the gathering of real-world patient data and can identify life-threatening conditions and facilitate early interventions. “For patients who are suspected of having dangerous arrhythmias like complete heart block, real-time Holter monitors can be used that are being continuously monitored by ECG techs who notify the prescribing cardiologist in the event of an alarm,” she explains. “Remote monitoring can also help to extend a patient’s life by improving management of their chronic conditions.”

“By detecting deterioration in its earliest stages, remote patient monitoring can alert patients, caregivers and providers and support early interventions to correct the course before a dangerous situation develops,” says Lee Schwamm, MD, FAHA, a volunteer member of the American Heart Association’s Center for Telehealth Expert Panel. “Remote patient monitoring is an increasingly important tool in modernizing healthcare delivery. It enables continuous tracking of vital signs and health metrics, allowing early detection of non-adherence to medications, need for medication titration or lifestyle modification, or urgent medical concerns such as dangerous blood pressure elevations or cardiac arrhythmias. This leads to timely interventions and prevents complications.

“It also enhances access to care in two key ways: Firstly, patients in rural or underserved areas can receive highquality care without frequent in-person visits, and potentially avoid visits to the emergency department or hospitalizations due to predictable and preventable deteriorations. This is especially important for those with mobility issues or chronic conditions. Secondly, this frees up access for new patient office visits or those with more serious medical conditions. These aspects empower patents to participate in their care, make care delivery more efficient [and] cost-effective and help get patients to their health goals faster.”

Dr. Thakkar reiterates remote monitoring’s importance: “Remote patient monitoring is important because many cardiovascular conditions, such as arrhythmias, heart failure and hypertension, progress silently before symptoms appear. In these conditions, remote patient monitoring transforms care by allowing early detection of disease progression to facilitate early intervention. Furthermore, whereas care today is mostly episodic, remote monitoring allows for continuous monitoring of certain parameters that can paint a more accurate picture of a patient’s health.”

Remote Cardiac Monitoring Systems

Several medical device companies have developed systems that transform how healthcare providers conduct remote patient monitoring for their cardiac patients.

AliveCor’s Kardia 12L ECG system.3 AliveCor, focused on transforming cardiovascular care for a heart-healthier future, developed the Kardia 12L ECG system, the world’s first AI-powered, handheld 12-lead ECG system, featuring a single-cable design and reduced lead set. It is U.S. Food and Drug Administration (FDA)-cleared and powered by the advanced KAI 12L AI algorithm, which can detect 35 life-threatening cardiac conditions, including acute myocardial infarction and common types of ischemia.

What distinguishes Kardia 12L is its combination of power and portability. Weighing just 0.3 pounds and fully battery-operated, it is more compact than typical 12L ECG solutions that can weigh more than 15 pounds, making it ideal for use in remote, outpatient or spaceconstrained environments.

Recent clinical studies demonstrated Kardia 12L cuts ECG acquisition time and delivers accurate, actionable data comparable to traditional 12-lead ECG machines. A 2025 peer-reviewed study in the journal Heart Rhythm O2 showed Kardia 12L cuts ECG acquisition time by 29 percent versus standard 12L ECG. A study presented in 2024 at the Heart Rhythm Society also found Kardia 12L enabled rapid acquisition of resting ECG information, with measurements and interpretations highly similar to standard 12-lead ECGs.

Another study in 2024 presented at the Computing in Cardiology conference in Germany showed that a reduced ECG lead set, as used in Kardia 12L, exhibited comparable, excellent performance in detecting major morphological cardiac abnormalities, including heart attack, as a standard 12-lead ECG.

Using only a single cable with five electrodes to acquire eight high-quality diagnostic bandwidth leads, Kardia 12L ECG combines the power of KAI 12L’s AI technology and the Kardia 12L. This design makes it possible for more providers in a wider range of settings, including primary care offices, urgent care clinics, employer clinics and rural locations, to access and integrate 12-lead ECG data into cardiac care. Additionally, the device’s streamlined lead set improves patient experience by reducing the need for full disrobing, making the ECG process faster, more comfortable and less invasive.

Kardia 12L delivers a clinically validated, hand-held, 12-lead ECG system that enables rapid, hospital-grade cardiac assessments anywhere. This is especially impactful in rural areas, where heart disease incidence is 40 percent higher than in urban settings and access to timely diagnostics is limited. Using Bluetooth technology, Kardia 12L wirelessly transmits ECG data to a clinician’s smartphone or tablet, enabling a comprehensive view of heart activity in just minutes.

“Not only is KAI 12L the first FDAcleared AI that can detect a heart attack on a reduced lead set, but it also returns determinations for our broadest range of conditions yet,” says Priya Abani, CEO of AliveCor. “Paired with our pocket-sized Kardia 12L ECG system, this offering is poised to disrupt traditional care pathways and represents a leap forward in cardiac care.”

InfoBionic.Ai’s MoMe ARC platform.4 InfoBionic.Ai, a virtual telemetry company focused on the efficiency and economics of remote patient monitoring for cardiac patients, developed the MoMe ARC platform. Originally introduced in 2014, the most recent version was launched in May 2024.

The MoMe ARC platform is an AI-driven, cloud-based platform that combines reliable devices, actionable data and a robust analytics suite into one continuously connected ecosystem. It is an FDA-cleared platform that continuously streams six-lead ECG data in near real-time that provides hospitalgrade visibility for cardiac care regardless of patient location. Unlike wearables or traditional systems that sample or compress data, MoMe ARC provides fulldisclosure ECG monitoring, capturing 100 percent of every heartbeat.

The platform includes a discreet wearable six-lead sensor that provides remote cardiac telemetry that can detect 20 FDA-cleared determinations. Depending on the arrhythmia, the sensor can trigger a direct call, text or email to a clinician. Its lightweight design, at 80 grams (it fluctuates +/- 5 grams due to production), integrates seamlessly into patients’ routines to ensure comfort and adherence.

The platform also includes a onelead patch that operates independently or with an external cellular or Wi-Fi-based gateway and allows for flexibility between single and multi-lead configurations for patients’ convenience and quality of data.

One wearable sensor supports Holter, Extended Holter, Event and Mobile Cardiac Telemetry modes, which is switchable without changing hardware or the need to have patients return to their provider’s location. Clinicians can review every heartbeat, not just flagged events, within minutes of occurrence, enabling faster, more informed intervention.

The platform’s core arrhythmiaclassification engine is built on greater than 99 percent accuracy datasets, and a new collaboration with Anumana is adding FDA-cleared algorithms for low ejection fraction, pulmonary hypertension, cardiac amyloidosis and more.

MoMe Analytics gives providers powerful views of clinical, operational and financial metrics without the need to rely on third-party tools.

The MoMe ARC platform supports both multi-lead and patchbased configurations using the same rechargeable core, offering flexibility for different patient needs. Bluetooth-enabled sensors and a cellular gateway ensure uninterrupted data flow, even without Wi-Fi or phone connectivity. All data and reports are managed through a platform that integrates directly with emergency health records, reducing administrative friction. It is compact, water-resistant and intuitive to use, which improves patient comfort and compliance, leading to higher-quality, reliable data.

“We are proud to unveil a comprehensive suite of cutting-edge advancements that will equip providers with a powerful ecosystem of solutions designed to optimize every aspect of remote cardiac monitoring — from patient comfort and data quality to operational efficiency and clinical performance,” says Stuart Long, CEO at InfoBionic.Ai. “By empowering providers to access, understand and utilize both practice and patient data more effectively, we look to forge ahead in our mission to advance more effective remote cardiac care.”

iRhythm Technologies’ Zio suite of products.5 iRhythm Technologies, a digital healthcare company that creates solutions that detect, predict and prevent disease, developed the Zio suite of products. Zio combines wearable biosensors and cloud-based data analytics with powerful proprietary algorithms to provide remote patient monitoring services for cardiac patients. The company’s comprehensive clinical evidence program encompasses more than 125 original research manuscripts, insights derived from more than two billion hours of curated heartbeat data and more than 10 million patient reports.

Zio monitor is a single-lead patch ECG device. It is breathable, using a hydrocolloid adhesive and waterproof housing, requiring no device or adhesive manipulation or battery change during the entire wear and monitoring period. The monitor is the next generation of iRhythm’s Zio LTCM service, which provides continuous, uninterrupted recording for up to 14 days and provides physicians a comprehensive and actionable end-of-wear report to make a diagnosis.

iRhythm’s ZEUS System, an advanced AI algorithm, supports the capture and analysis of data recorded by the monitor. The Zio monitor is 23 percent thinner, 62 percent lighter and 72 percent smaller than the previous generation. And, it demonstrates 99 percent patient compliance with prescribed wear times.

The end-to-end service includes ZioSuite for providers, which interprets reports, manages patients from any device and tracks patient monitors. And the My Zio patient app supports patients throughout their monitoring journey with digital symptom logging, educational content and reminders.

The Zio AT mobile cardiac telemetry monitoring service includes a patch ECG device and provides continuous, uninterrupted recording for up to 14 days. It provides physicians with an actionable wear-time report, alerting them during those 14 days if an arrhythmia is detected.

iRhythm is the first company in the ambulatory cardiac monitoring category to leverage an FDA-cleared deep-learning algorithm for ECG interpretation. This AI-driven approach enhances diagnostic accuracy and efficiency by comparing collected data against a vast database of diagnosed arrhythmias, improving precision and aiding physicians in making accurate diagnoses the first time.

iRhythm’s deep-learned algorithm enhances the performance of cardiologist interpretation, bringing precision to an industry where every percentage point matters. The technology’s effectiveness is underscored by a 99 percent agreement rate, whereby the interpreting cardiology physician will not change the AI-guided and human expert-validated preliminary interpretation from Zio.

The Zio service can improve clinical outcomes since it is two times more likely to result in specified arrhythmia diagnoses compared to Holter monitoring services. It is also 72 percent more likely to result in specified arrhythmia diagnoses compared to event monitoring services. And it provides 2.6 times greater detection of atrial fibrillation versus routine cardiac care.

In the largest real-world evidence study of ambulatory cardiac monitoring published in the American Heart Journal in March 2024, the Zio LTCM service was associated with the highest clinical diagnostic yield, lower odds of retesting and lowest acute care healthcare resource utilization compared to all other monitoring services in the study.

“With wearable solutions like iRhythm’s Zio service, patients can receive a medical-grade ECG monitor by mail, self-apply and activate it at home and return it — all without an in-person visit,” said Mintu Turakhia, MD, MS, chief medical and scientific officer at iRhythm. “The resulting data is analyzed by FDA-cleared AI and reviewed by qualified cardiac technicians to generate a clinical report that supports physicians in making timely, informed diagnoses.”

Remote Cardiac Monitoring: The Future

Remote patient monitoring assists providers with expanded access to accurate patient heart data and rapid disease detection, and addresses gaps in monitoring rural and remote patients. It also helps patients with enhanced treatment experience, reduced hospital visits and improved health outcomes.

According to Dr. Thakkar, cardiovascular care relies heavily on data to make diagnoses and guide therapeutic interventions, making remote patient monitoring essential: “In the future, I envision data from remote monitoring devices flowing directly into our existing clinical systems to facilitate easier use of this data in clinical decision-making.”

She also says another major challenge with remote patient monitoring data involves data management: “When large amounts of data are collected on a daily basis, it is overwhelming for clinicians to interpret and use this data to guide decisions. I envision a future in which data analytics are used to consolidate large amounts of remote-monitoring data and present clear and accurate management recommendations on the guidelinedirected next steps. In certain cases where management is driven by algorithms or guidelines, physician extenders or pharmacists can even implement these next steps, involving the physician only in edge cases. Systems like this will not only improve a cardiologist’s efficiency but also enable population-based chronic disease management.”

In the future, Dr. Schwamm believes wearable and implanted remote patient monitoring devices will be a commonly used method for disease management, and autonomous AI software will help monitor the data produced by these devices, freeing up doctors and nurses to attend to the patients who most need their attention: “Visits to the doctor will be data-driven, based on need and predicted outcomes, and not scheduled at arbitrary intervals like every three months or annually. Patients will be more actively engaged in measuring and monitoring their own health-related data, and will be supported by AI ‘agents’ that will converse with them in their own language and literacy level, and provide medical and emotional support to help them adhere to their care plans. When procedures are required, AI will help improve the diagnostic studies that are performed and better guide treatments through the use of robotics and advanced algorithms.”

 

 

References

  1. American Heart Association. More Than Half of U.S. Adults Don’t Know Heart Disease Is Leading Cause of Death, Despite 100-Year Reign, Jan. 24, 2024. Accessed at newsroom.heart.org/news/more-than-half-of-u-s-adults-dont-know-heart-disease-is-leading-cause-of-death-despite-100-year-reign.
  2. The Cardiologist Shortage by the Numbers: Here Are Four Statistics on the Cardiologist Shortage That Leaders Should Know. Becker’s ASC Review, Nov. 15, 2023. Accessed at www.beckersasc.com/cardiology/the-cardiologist-shortage-by-the-numbers/?oly_ enc_id=4789F3174345J0I.
  3. AlivCor. Kardia 12L. Accessed at alivecor.com/products/kardia12l.
  4. InfoBionic.Ai. MoMe ARC. Accessed at infobionic.ai/mome-arc.
  5. iRhythm. Zio ECG Monitors. Accessed at www.irhythmtech.com.
Diane L.M. Cook
Diane L.M. Cook, BComm, is a freelance trade magazine writer based in Canada.