HeartBeam Inc. (NASDAQ: BEAT) FDA-Cleared System Provides Momentum as Company Moves to Innovate Cardiac Care

• The FDA-cleared HeartBeam system enables patients and physicians to access significant arrhythmia data outside traditional clinical settings.
• The HeartBeam system, credit card–sized and fully portable, represents a breakthrough in ambulatory cardiac care. 
• Beyond ambulatory arrhythmia assessment, the platform is poised for future advancements, including synthesized 12-lead ECG generation.

Foundational clearance from the U.S. Food and Drug Administration (“FDA”) for its patented HeartBeam system has proved pivotal for HeartBeam (NASDAQ: BEAT), a cardiac technology company focused on transforming the cardiac-care space (https://ibn.fm/0TAG4). The first cable-free, high-fidelity ECG device that captures the heart’s electrical activity from three distinct directions, the HeartBeam system enables patients and physicians to access critical arrhythmia data outside traditional clinical settings.

The HeartBeam system, credit card–sized and fully portable, represents a breakthrough in ambulatory cardiac care. The device, which is equipped with five electrodes and records three-directional electrical signals over a 30-second period, is the first of its kind to receive FDA clearance in December 2024. When a patient experiences symptoms, the accompanying smartphone app walks them through capturing a recording. The recorded data is transmitted via the cloud, reviewed by a physician within the context of symptoms and medical history, and used to direct timely care. This capability significantly reduces diagnostic delays and enables proactive management of arrhythmias.

“It’s well documented that patients who delay seeking care for their cardiac symptoms face worse clinical outcomes,” said HeartBeam CEO Robert Eno. “The ability for patients to capture high-fidelity ECG signals from three distinct directions wherever they are when symptoms occur will help patients get the care they need in a timelier manner. The foundational FDA clearance of our technology for arrhythmia assessment 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.”

According to the company, the initial clearance paves the way for HeartBeam to initiate an Early Access Program, allowing patients and physicians to evaluate the system ahead of its commercial launch. This program is designed to refine user experience and workflow while providing real-world feedback ahead of broader market entry.

Beyond ambulatory arrhythmia assessment, the platform is poised for future advancements, including synthesized 12-lead ECG generation. HeartBeam’s proprietary personalized transformation matrix allows the system to convert the three-directional signals into a synthesized 12-lead ECG, a feature that is expected to provide access to actionable information, enabling physicians to direct patients to timely, appropriate care. The 12-lead ECG synthesis software is currently under FDA review with clearance anticipated later this year.

The company is also developing AI-powered algorithms to enhance arrhythmia detection; early data suggests promising improvements in identifying atrial flutter and other rhythm disturbances, with performance in some cases surpassing cardiologists. HeartBeam plans to submit its AI algorithms for FDA clearance in the future. 

HeartBeam’s technology is underpinned by a robust intellectual property portfolio, which now includes more than 20 issued U.S. and international patents, as well as 2 allowed patents and 32 pending patents (https://ibn.fm/JT9mB). HeartBeam is now building upon the FDA clearance, with a clear runway toward commercial deployment in arrhythmia diagnostics and beyond.

As HeartBeam progresses toward broader clinical adoption, its focus remains on integrating patient-generated ECG data into daily care pathways. Remote monitoring and telehealth platforms stand to benefit from this innovation, particularly in managing chronic cardiac conditions and minimizing hospital readmissions. HeartBeam’s technology aligns with the growing movement toward decentralized, intelligent diagnostics.

With the foundational FDA clearance secured, HeartBeam plans to expand access through early access programs, deploy field-testing among medical practices and ultimately commercialize the system. The anticipated sequence of steps includes physician training, system support and data collection to streamline regulatory and commercial readiness. With a transformative roadmap in place, HeartBeam is positioned to redefine the future of cardiac care, taking it outside the hospital and putting it into the hands of patients and clinicians alike.

For more information, visit 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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