HeartBeam’s Credit Card-Sized Cardiac Monitor Cleared for At-Home Use

Imagine having a heart monitoring device small enough to fit in a purse or a wallet, ready to record critical heart data whenever symptoms arise. This device by HeartBeam, Inc. is a breakthrough in at-home cardiac care, allowing patients to capture high-quality electrocardiograms (ECGs) wherever they are.

When symptoms occur, patients simply place the device on their chest and follow prompts from a companion app. In just 30 seconds, the device records electrical signals from the heart and sends them securely to the cloud, without waiting for a clinical visit. A physician reviews the data alongside the patient’s medical history, helping to determine the next steps in care.

The US Food and Drug Administration (FDA) recently cleared HeartBeam’s system, recognizing it as the first cable-free ECG device capable of capturing heart signals from three distinct directions. This clearance validates the device’s potential to transform cardiac monitoring, offering patients and physicians a timely solution to evaluate symptoms without requiring a clinical visit.

HeartBeam’s cardiac monitoring system goes beyond traditional at-home monitors. It synthesizes signals into a comprehensive 12-lead ECG — the standard in heart diagnostics — providing detailed insights to detect arrhythmias and other cardiac events with high accuracy.

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Future advancements are already in motion. HeartBeam is integrating AI to refine arrhythmia detection and assess heart attack risk remotely. Early studies have shown promise, with algorithms achieving performance levels comparable to — or even exceeding — expert cardiologists in certain diagnostic tasks.

To ensure readiness for a broad rollout, HeartBeam is initiating an Early Access Program to collect feedback from patients and physicians. This feedback will shape the final product ahead of its commercial launch, which is expected soon.

Telehealth interventions, including remote monitoring, have been shown to reduce unplanned heart failure hospitalizations, shorten hospital stays and lower mortality rates.

There has been a spectrum of medical devices designed for quick and efficient cardiac monitoring, each lightening the diagnostic burden at the clinic.

In 2019, AliveCor introduced KardiaMobile 6L, the first six-lead ECG device for at-home use, offering accessible and portable arrhythmia detection. More recently, Ventric Health’s cardiac monitor has focused on managing heart failure with advanced fluid status monitoring.

While accessible and versatile, these devices do not currently offer the high-fidelity, multi-directional ECG data and synthesized 12-lead capabilities that HeartBeam’s system provides — bringing clinical-grade precision to diagnosing arrhythmias and heart attack risks.

With its portability and advanced diagnostic capabilities, the HeartBeam system has the potential to accelerate timely care and improve overall care quality.