- Company releases report updating status of proprietary 12-lead ECG synthesis software for arrhythmia assessment.
- Earlier this year, HeartBeam submitted its software application to the U.S. Food and Drug Administration.
- Plans will ensure that healthcare providers and patients can seamlessly integrate the HeartBeam system into clinical workflows and home-monitoring routines.
In its most recent quarterly update, HeartBeam (NASDAQ: BEAT) is reporting that the company is on the verge of revolutionizing cardiac diagnostics with its groundbreaking ECG technology. The company is actively preparing for FDA 510(k) clearance of its innovative 12-lead ECG synthesis software for arrhythmia assessment while executing comprehensive commercial readiness plans for a technology that could transform how heart health is monitored both in clinical and home settings (https://ibn.fm/dz7rY).
“In the quarter, we continued to engage in positive and productive discussions with the FDA on the 12-lead ECG synthesis software submission for arrhythmia assessment, and we continue to anticipate clearance by the end of the year. . . . That clearance, together with our foundational clearance, will form the basis for our commercial launch,” said HeartBeam CEO Robert Eno. “We continue to make significant progress with commercial readiness plans, which is positioning us for a successful launch following 510(k) clearance of our 12-lead synthesis software.”
Earlier this year, HeartBeam submitted its 12-lead ECG synthesis software application to the U.S. Food and Drug Administration (“FDA”). The FDA submission was supported by robust clinical evidence and data demonstrating both safety and effectiveness. The company is engaged in ongoing discussions with the FDA regarding its 510(k) application and anticipates clearance by the end of 2025. FDA clearance would mark a major milestone, allowing HeartBeam to expand access to this cutting-edge technology beyond clinical environments.
To prepare for commercial launch, HeartBeam has developed comprehensive readiness plans. These plans include finalizing a cardiology reader service that allows on-demand physician review of synthesized 12-lead ECGs, establishing customer service infrastructure and implementing contract manufacturing and logistics systems. The goal is to ensure that healthcare providers and patients can seamlessly integrate the HeartBeam system into clinical workflows and home-monitoring routines.
HeartBeam’s innovative approach has been recognized within the medical industry. The company has received more than 20 patents for its cardiac diagnostic technology, highlighting the uniqueness of its methods and the potential impact on heart care. In addition, HeartBeam was awarded the Innovation Award in Remote Cardiac Diagnostics as part of the 2025 Medical Device Network Excellence Awards for its groundbreaking ECG technology, and was named a finalist in the 2025 Octane High Tech Awards, which recognizes innovators, entrepreneurs and technology leaders with a presence in Orange County. These industry awards further validate the clinical relevance and technological ingenuity of HeartBeam’s solutions.
Looking forward, HeartBeam plans to initiate commercialization immediately upon receiving FDA clearance. The company’s vision is to empower patients and healthcare providers by offering a portable, cable-free ECG solution that combines clinical-grade accuracy with ease of use. This innovation is poised to reduce the burden on healthcare facilities, improve patient engagement, and increase the availability of high-quality cardiac monitoring, particularly in underserved areas or for patients requiring frequent arrhythmia assessments.
The traditional 12-lead ECG is essential for timely and accurate treatment decisions and is the cornerstone of cardiac care. Despite its clinical value, traditional 12-lead ECG systems are cumbersome, requiring multiple electrodes and wires, and are typically restricted to hospital or clinic use. This limits accessibility for patients and may result in delays in care.
HeartBeam’s synthesis software addresses these limitations by generating a full synthesized 12-lead ECG from a single, compact device for arrhythmia assessment. The system captures signals from three distinct directions and uses advanced algorithms to reconstruct a complete synthesized 12-lead waveform (https://ibn.fm/ldKfq). This approach reduces patient setup time, eliminates the inconvenience of external cables, and facilitates at-home or remote monitoring. The synthesized ECG maintains high fidelity, ensuring that physicians receive the same level of diagnostic detail as traditional systems. Clinical data from the pivotal VALID-ECG study demonstrated a 93.4% overall diagnostic agreement, confirming that HeartBeam’s software can accurately support assessment of arrhythmias.
As the healthcare industry increasingly embraces telemedicine and remote patient monitoring, HeartBeam’s 12-lead ECG synthesis software represents a significant leap forward. By providing a high-fidelity, multidirectional signals of the heart in a compact form factor, the system stands to transform cardiac care, making it more accessible, efficient and patient centered. HeartBeam continues to advance its mission of modernizing heart health monitoring, offering both physicians and patients the tools needed for proactive and informed cardiovascular care.
For more information, visit www.HeartBeam.com.
NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT
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