HeartBeam, Inc. (NASDAQ: BEAT), a company dedicated to revolutionizing cardiac care, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its HeartBeam system for comprehensive arrhythmia assessment. The HeartBeam device, featuring a patented design, is the first of its kind to receive this FDA clearance. As a high-fidelity electrocardiogram (ECG) system, it offers a credit card-sized, cable-free design that captures heart signals from three distinct directions, providing actionable insights into heart health.
HeartBeam, Inc. (NASDAQ: BEAT), a medical technology innovator, has received FDA 510(k) clearance for its groundbreaking HeartBeam system, marking a significant milestone in its mission to revolutionize cardiac care. The HeartBeam system provides high-fidelity electrocardiogram (ECG) recordings with a unique, portable, and cable-free design. Patients can now capture heart signals from three distinct directions, offering invaluable insights into their heart health anytime and anywhere.
The HeartBeam patient app guides users through the process of capturing a 30-second ECG recording when symptoms occur. Once the patient records the ECG, the data is sent to the cloud, processed, and reviewed by a physician. This enables a fast, efficient, and convenient way for physicians to analyze the patient’s heart signals, taking into account the patient’s symptoms and medical history. Based on this analysis, the physician can then provide follow-up guidance on the next steps for the patient’s care.
HeartBeam plans to initiate an Early Access Program for interested patients and physicians and has created a waitlist for those looking to participate. This move is part of HeartBeam’s larger vision to make high-quality cardiac monitoring accessible to individuals in the comfort of their own homes, improving the timeliness and accuracy of care.
Robert Eno, CEO of HeartBeam, emphasized the importance of the FDA clearance in enabling patients to act swiftly on cardiac symptoms. “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,” Eno stated. “The FDA clearance of our technology is a significant milestone that brings us closer to providing unprecedented cardiac insights to individuals and physicians.”
This FDA clearance lays the foundation for future advancements, including the ability to synthesize a 12-lead ECG from the three-directional signals collected by the HeartBeam system. This feature could provide more comprehensive cardiac data and further enhance the device’s diagnostic potential. Additionally, HeartBeam is working on incorporating AI-based classification algorithms to improve the detection of arrhythmias such as atrial flutter. Their deep learning algorithms have shown promise in outpacing cardiologists in identifying certain heart conditions.
Another major development for HeartBeam is its potential for heart attack detection. A study published in JACC: Advances showed that HeartBeam’s technology, when used in an ambulatory setting, is comparable to a standard 12-lead ECG in identifying coronary occlusions with high accuracy (95% Area Under the Curve). Another feasibility study explored the technology’s potential to assess chest pain and calculate a heart attack risk score remotely, providing patients and doctors with additional tools for monitoring heart health.
HeartBeam aims to leverage artificial intelligence to analyze long-term ECG data from patients, creating a longitudinal view of cardiac health that can predict conditions before symptoms appear. This innovative approach has the potential to shift the paradigm of cardiovascular care, allowing for earlier intervention and more personalized treatment plans.
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is committed to transforming the detection and monitoring of critical cardiac conditions. The company’s technology delivers a cable-free synthesized 12-lead ECG capable of capturing the heart’s electrical signals from three distinct directions. This portable solution allows patients to gather ECG data anywhere, enabling physicians to monitor health trends, identify conditions, and direct patients to appropriate care without the need for a medical facility visit.
About the HeartBeam System
The HeartBeam System is a portable, non-invasive device that records and transfers a patient’s 3-lead ECG signals acquired from five electrodes. Intended for use by adults in both clinical settings and at home, the system facilitates manual interpretation of non-life-threatening arrhythmias by healthcare professionals. For more details, visit HeartBeam.com.
