HeartBeam, Inc. is a development stage company, which engages in cardiovascular diagnostic technology. Its electrocardiogram (ECG) collection device provides physicians with cardiac diagnostic information for a patient that is outside of a medical institution. The device sends ECG signals to the patient's smartphone and on to a cloud-based software expert system. The company was founded by Branislav Vajdic in 2015 and is headquartered in Santa Clara, CA.
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- The global wearable cardiac monitoring devices market was valued at USD 2.9 billion in 2025 and is projected to reach USD 10.3 billion by 2036, expanding at a CAGR of 12.1%. - The electrocardiography (ECG) technology segment dominated the market in 2025, accounting for approximately 62.1% of total revenue, driven by its clinical accuracy in detecting arrhythmias and atrial fibrillation. - North America held the largest regional share at 41.2% in 2025, supported by advanced healthcare infrastructure and growing adoption of remote patient monitoring solutions. - Rising prevalence of cardiovascular diseases and cardiac arrhythmias, coupled with growing demand for continuous, real-time cardiac monitoring, is the primary growth driver.
- HeartBeam and Mount Sinai's Icahn School of Medicine announced a strategic collaboration to develop next-generation AI-ECG algorithms for home-based cardiac monitoring. - The partnership leverages HeartBeam's patented 3D ECG technology that captures 12-lead ECG data from patients anywhere, extending cardiac assessment beyond traditional clinical settings. - The collaboration aims to create personalized AI algorithms for wellness applications and clinical assessments, including heart attack risk evaluation, using longitudinal real-world ECG data. - HeartBeam's platform received FDA clearance for arrhythmia assessment in December 2024, positioning the company to expand into new clinical indications and reimbursement pathways.
- HeartBeam received FDA 510(k) clearance for its groundbreaking 12-lead ECG synthesis software following a successful appeal of a prior Not Substantially Equivalent determination. - The credit-card sized device captures heart electrical signals in three dimensions and synthesizes them into a 12-lead ECG representation for at-home arrhythmia assessment. - The company plans a limited commercial launch in Q1 2026 with select cardiology practices and aims to expand into heart attack detection and AI-based screening algorithms. - The technology addresses a key challenge in cardiology by enabling patients to capture clinically meaningful ECG data when symptoms occur outside medical facilities.
- HeartBeam received a Not Substantially Equivalent (NSE) decision from the FDA on its 510(k) submission for 12-lead ECG synthesis software, prompting the company to explore multiple regulatory pathways. - The company's VALID-ECG clinical study met its agreed-upon endpoints, and HeartBeam believes labeling modifications can address the FDA's outstanding concerns. - HeartBeam plans to pursue parallel approaches including an appeal process with a 60-day timeline or resubmission of a new 510(k) application. - The company's 3D ECG technology already received FDA clearance for arrhythmia assessment in December 2024, providing a foundation for continued cardiac monitoring innovation.
- HeartBeam has submitted a 510(k) application to the FDA for its 12-lead ECG synthesis software, designed to assess various cardiac rhythms and arrhythmias. - The submission is supported by data from the VALID-ECG pivotal study, involving 198 patients across five clinical sites, demonstrating clinical equivalence to standard ECGs. - The software synthesizes signals from three directions into a 12-lead ECG, using a personalized transformation matrix, for convenient cardiac monitoring. - Future advancements include AI-based classification algorithms and heart attack detection, aiming to reduce 'symptom to door' times for patients.
