- HeartBeam has developed the first cable-free system capable of synthesizing a 12-lead ECG from 3D, non-coplanar electrical signals captured in real time.
- Patients can have the HeartBeam System with them at all times, ready to record an ECG in 30 seconds at home or anywhere when they feel symptoms to reduce delays in care.
- The HeartBeam System is now FDA cleared for arrhythmia assessment, with additional FDA review underway for its 12-lead ECG synthesis software for the same indication.
- A recent partnership with AccurKardia enhances HeartBeam’s arrhythmia solution with an FDA-cleared automated rhythm interpretation software.
- HeartBeam holds 20 issued patents, with additional allowed and pending applications, protecting its proprietary hardware, software, and algorithmic capabilities.
- Commercial launch is expected to be imminent, targeting a $500 million concierge SAM and broader multibillion-dollar patient pay market, supported by a high-margin, recurring revenue model.
HeartBeam (NASDAQ: BEAT) is a medical technology company developing a groundbreaking solution for at-home detection and monitoring of cardiac conditions. The company is creating the first ever cable-free synthesized 12-lead ECG platform designed to give patients the ability to record their symptoms the moment they occur, wherever they are. By providing synthesized, 12-lead ECG data, physicians can quickly assess the symptoms and ensure patients get the care they need in a timely manner. It also eliminates the need for wires, complex setup, or clinical staff, thus allowing synthesized 12-lead ECG signals to be accessible outside of a medical setting.
HeartBeam’s vision is to redefine cardiac care by enabling early detection, proactive monitoring, and informed clinical decisions outside the confines of a traditional medical setting. Its patented approach not only delivers similar, but not identical, accuracy of conventional 12-lead ECGs for arrhythmia detection but also unlocks future capabilities in ischemia detection, AI-assisted analysis, and longitudinal cardiac trend tracking.
The HeartBeam System is now FDA cleared for arrhythmia assessment, following foundational 510(k) clearance granted in December 2024. The company submitted a 510(k) application for its 12-lead ECG synthesis software in January 2025 for arrhythmia assessment. As it approaches commercialization, HeartBeam is executing a multi-phase go-to-market strategy with initial U.S. rollout plans and a focus on high-margin, recurring revenue.
The company is headquartered in Santa Clara, California.
Products
HeartBeam’s flagship product is a credit card-sized, cable-free device designed to capture ECG signals in three non-coplanar directions and transform them into synthesized 12-lead ECGs. This novel form factor integrates a smartphone app, cloud connectivity, and a physician portal, enabling patients to record cardiac events at the moment symptoms occur and physicians to assess and triage in near real time.
The device is supported by an expanding software ecosystem. A key component of this is HeartBeam’s proprietary 12-lead ECG synthesis software, which met its clinical endpoint in the VALID-ECG pivotal study with 93.4% manual diagnostic agreement for arrhythmia assessment. This software is currently under FDA review and is designed to deliver clinical-grade arrhythmia diagnostic capabilities outside of traditional healthcare environments.
In April 2025, HeartBeam announced a strategic partnership with AccurKardia to incorporate its FDA-cleared ECG analysis software, AccurECG(TM), into HeartBeam’s offering. This integration is expected to enhance automated rhythm interpretation, streamline physician workflows, and improve diagnostic speed and accuracy.
Additional form factors are under development, including an on-demand synthesized 12-lead patch with issued patents, intended to serve the extended-wear market segment. These complementary offerings are intended to support chronic disease management and continuous monitoring applications, broadening HeartBeam’s total product ecosystem in the future.
Market Opportunity
HeartBeam is targeting large and growing segments within the $20 billion+ global cardiac monitoring and diagnostics market. According to the company’s own materials, the U.S. concierge care segment alone represents a $500 million serviceable addressable market (“SAM”), comprising approximately 1.5 million patients—500,000 of whom are at elevated cardiac risk. This initial focus provides a strategic entry point for cash-pay and early adoption.
Expanding beyond this niche, HeartBeam identifies a $1.3 billion to $2.6 billion annual opportunity in the broader U.S. direct patient pay market, driven by more than 2.6 million high-income individuals aged 35–74 with elevated cardiac risk. For comparison, more than 2.5 million Oura rings and over 3 million AliveCor Kardia devices have been sold, demonstrating strong consumer willingness to adopt personal cardiac technologies.
HeartBeam’s long-term opportunity is significantly larger. The company estimates that over 20 million people in the U.S. are at high risk for myocardial infarction (“MI”), representing a total addressable market nearly 40 times greater than the concierge segment. Additionally, the company’s on-demand 12-lead patch aims to capture market share in the extended wear and mobile cardiac telemetry (“MCOT”) space, competing with incumbents like iRhythm, Boston Scientific, Philips, and Baxter.
Leadership Team
Robert P. Eno, Chief Executive Officer and Director, brings over 30 years of experience launching disruptive medical technologies and leading commercialization efforts. He has held executive roles at HeartFlow, OptiMedica, NeoGuide Systems, and Avantec Vascular, and holds an MBA and BA from Stanford University.
Branislav Vajdic, PhD, President and Founder, is a seasoned innovator with over three decades of experience in technology and device development. He co-invented flash memory at Intel and led engineering teams responsible for the Pentium processor series. He previously served as CEO of NewCardio and holds a PhD in Electrical Engineering from the University of Minnesota.
Timothy Cruickshank, Chief Financial Officer, has over 15 years of experience in financial and strategic leadership roles. Formerly CFO at ImpediMed, he transformed the company into a SaaS-driven model. He holds an MBA from Keller Graduate School and a BS in Accounting from Syracuse University.
Peter J. Fitzgerald, MD, PhD, Chief Medical Officer, is a Stanford professor emeritus and interventional cardiologist with leadership in over 175 clinical trials and 24 medical startups. He co-founded TriVentures and has advised the FDA for over 20 years.
Ken Persen, Chief Technology Officer, has more than 25 years of experience in cardiac and digital health technology, including founding LIVMOR and leadership roles at Guidant and Cameron Health. He specializes in system design and product engineering for connected cardiac solutions.
For more information, visit the company’s website at 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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