News

HeartBeam Wins FDA Clearance for At-Home, High-Fidelity Heart Monitoring System

• By John K. Waters
• 12/16/2024

HeartBeam, a medical technology company focused on cardiac care, announced it has received U.S. Food and Drug Administration (FDA) clearance for its at-home, cable-free HeartBeam system for arrhythmia monitoring. The portable device, which is credit card-sized, allows patients to record electrocardiograms (ECGs) at any time, improving early detection of heart-related issues and reducing delays in care.

The HeartBeam system captures heart signals from three distinct directions, a patented feature designed to improve accuracy over traditional single-lead portable ECGs. Patients place the device on their chest during symptoms, recording a 30-second ECG that is sent to the cloud for physician review.

"Patients who delay care for cardiac symptoms often experience worse clinical outcomes," said Robert Eno, Chief Executive Officer at HeartBeam, in a statement. "This clearance brings us closer to fulfilling our vision of delivering actionable cardiac insights to patients and physicians in real-time."

HeartBeam’s technology aims to address significant challenges in cardiovascular care by offering tools that can provide high-fidelity, near-clinical ECG readings outside medical facilities.

While the current clearance supports arrhythmia monitoring, HeartBeam outlined future enhancements:

• Synthesized 12-Lead ECG: The system will be capable of transforming its 3-directional signals into a full 12-lead ECG, a clinical standard for detecting cardiac abnormalities.

• AI Detection Algorithms: Using deep learning, HeartBeam aims to enhance arrhythmia detection, with studies showing improved identification of conditions like atrial flutter.

• Heart Attack Detection: Research published in JACC: Advances demonstrated the technology’s accuracy in identifying coronary occlusions, comparable to traditional 12-lead ECG machines.
• The company also emphasized its goal of leveraging AI for predictive insights, analyzing patient data over time to anticipate cardiac events before symptoms appear.

HeartBeam plans to launch an Early Access Program to gather feedback from patients and physicians ahead of commercial release. The device’s portability and cable-free design make it suitable for both clinical settings and at-home use, a step toward more accessible and proactive cardiac care.

HeartBeam’s technology arrives amid growing demand for remote healthcare solutions, particularly for chronic conditions like heart disease, which remains a leading cause of mortality worldwide.