The FDA has cleared a portable ECG device that allows patients to capture a 30-second heart recording at home when symptoms occur, with the data sent to a physician for review and next steps.

Summary: HeartBeam Inc has received FDA 510(k) clearance for its high-fidelity, credit card-sized ECG system designed for arrhythmia assessment. The device captures heart signals from three directions, recording actionable health information in 30 seconds. Patients can use the device at home to record ECG data when they experience symptoms, and the data is sent to a physician for review. Future advancements include synthesized 12-lead ECGs, AI-based algorithms for better arrhythmia detection, and heart attack risk detection. The company plans to expand access through an early access program.

Key Takeaways:

  1. FDA Clearance: HeartBeam’s portable ECG system has received FDA clearance for arrhythmia assessment, offering patients a way to capture high-fidelity ECGs at home.
  2. How It Works: Patients can have the credit card-sized device with them at all times, ready to record an ECG whenever they feel symptoms and reduce delays in care.
  3. Remote Heart Attack Risk Detection: HeartBeam’s technology has shown potential in accurately identifying heart attack risks and providing valuable predictive insights for heart health.

Medtech company HeartBeam Inc announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance of the HeartBeam system for arrhythmia assessment. 

As a high-fidelity electrocardiogram (ECG) system with a credit card-sized form factor and cable-free design, it captures heart signals from three directions for actionable heart health information.

When a patient feels symptoms, the HeartBeam patient app guides them through the process of placing the device on their chest and capturing a 30-second recording. Once a recording is taken, the signals are sent to the cloud, processed, and sent to a physician for review. The physician reviews the ECG recording in the context of the patient’s symptoms and medical history and then follows up with the patient on next steps. 

The company plans to initiate an early access program and is creating a waitlist of interested patients and physicians.

“It’s well documented that patients who delay seeking care for their cardiac symptoms face worse clinical outcomes. The ability for patients to capture high-fidelity ECG signals from three directions wherever they are when symptoms occur will help patients get the care they need in a timelier manner,” says Robert Eno, chief executive officer at HeartBeam, in a release. “The FDA clearance of our technology is a significant milestone for the company that brings us one step closer to fulfilling our vision of providing unprecedented cardiac insights to individuals and physicians.”

Advances in AI and ECG Synthesis

The FDA clearance will serve as the basis for future submissions as the company works to simplify access to intelligent and actionable 12-lead ECGs for both patients and physicians. 

Future planned advances include:

  • Synthesized 12-lead ECG: The HeartBeam system is designed to be capable of synthesizing the heart’s signals collected from three directions into a 12-lead ECG using a personalized transformation matrix as demonstrated in a pilot study.
  • AI-Based Classification Algorithms: Data presented earlier this year demonstrated that HeartBeam’s deep learning algorithm has the potential to greatly improve the detection of atrial flutter, even outperforming cardiologists in detecting some arrhythmias.
  • Heart Attack Detection: A study published in JACC: Advances showed that HeartBeam’s ambulatory technology is comparable to a standard 12-lead ECG in identifying coronary occlusions and is highly accurate (area under the curve of 95%). Another feasibility study highlighted the potential of HeartBeam’s technology to calculate a heart attack risk score to assess chest pain remotely.

“HeartBeam’s proprietary technology has the potential to unlock valuable diagnostic and predictive insights. The ease of collecting higher-fidelity ECG signals will enable patients to gather a series of recordings over time,” reads a release from HeartBeam. “The company aims to leverage AI to analyze this rich set of data, delivering a longitudinal view of a patient’s cardiac health and predicting cardiac conditions before symptoms appear.”

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