HeartBeam, Inc. develops medical technology for ambulatory cardiac monitoring, centered on a patented cable-free 3D ECG platform that captures signals from three non-coplanar dimensions and synthesizes a 12-lead ECG. News commonly covers the FDA-cleared HeartBeam System for arrhythmia assessment, limited commercial launch activity, preventive cardiology and concierge practice deployments, AI-ECG collaboration, and development of on-demand patch and heart attack detection initiatives.
Corporate updates also include financial results and common-stock financing used to support commercialization, product development, AI capabilities, working capital, and general corporate purposes.
HeartBeam (NASDAQ: BEAT) has gained acceptance into the FDA’s Total Product Life Cycle Advisory Program Pilot for its heart attack assessment technology. Acceptance follows Breakthrough Device Designation earlier this month for assessing potential heart attacks outside medical settings.
The program provides dedicated FDA advisors and early engagement with payers, patient groups and providers on development, reimbursement and adoption. HeartBeam has held its first meeting with its advisors. The company expects to seek FDA agreement on its multicenter pivotal study design in the coming months and anticipates starting enrollment in Q1 2027. A successful study is intended to support a submission to add heart attack assessment to the system’s indications.
HeartBeam does not currently anticipate needing new hardware. Program participation does not change regulatory requirements or guarantee FDA authorization or coverage.
HeartBeam (NASDAQ: BEAT) completed enrollment ahead of schedule in its HEADSTART-ACS heart attack detection study, enrolling 486 patients in Indonesia. Conducted at National Cardiovascular Center Harapan Kita in Jakarta, the study evaluates diagnostic accuracy for acute coronary syndrome, which includes heart attack. It compares standard 12-lead ECG and HeartBeam 3D ECG results against patients’ final diagnoses at discharge.
Data analysis is underway, with results anticipated for presentation at a cardiology conference in 2027. Alongside the 132-patient ALIGN-ACS pilot study, enrollment across the company’s heart attack detection studies exceeds 600 patients. HeartBeam plans to initiate its U.S. pivotal study in Q1 2027. The system is not currently cleared for heart attack detection, and its use in both studies is investigational.
HeartBeam (BEAT) has joined the European EXIT-CVD research consortium and will lead its HEART-CHECK study of at-home cardiac monitoring. The study will evaluate whether the HeartBeam System can help detect and triage recurrent cardiac events in high-risk patients recently discharged after acute coronary syndrome (ACS). It will assess clinical performance and integration into real-world care.
Led by University Medical Center Groningen and Royal Philips, EXIT-CVD brings together 42 partners across 17 countries, with 22 studies involving more than 14,000 patients and a EUR 27.6 million project budget. HeartBeam will contribute devices and clinical expertise in kind. Its system is not CE marked and is investigational for heart attack assessment; FDA clearance covers arrhythmia assessment only. Earlier this month, the FDA granted the system Breakthrough Device Designation for assessing potential heart attacks at home.
HeartBeam (BEAT) received FDA Breakthrough Device Designation for its system to help physicians assess potential heart attacks at home. The designation provides prioritized FDA review and interaction during development toward potential clearance. It was supported by proof-of-concept data presented in 2025 and findings from the 134-patient ALIGN-ACS pilot study.
HeartBeam expects to seek FDA alignment on a multicenter pivotal study design in the coming months, with enrollment shortly thereafter. A successful study is intended to support a future submission to add heart attack assessment to the system’s indications. The designation also enables pursuit of expedited Medicare coverage pathways; the proposed RAPID pathway would link a proposed coverage determination to clearance of an eligible device. HeartBeam expects ALIGN-ACS presentation and HEADSTART-ACS study updates in the coming weeks.
HeartBeam (BEAT) issued a shareholder letter outlining a strategic shift to prioritize development of its myocardial infarction (heart attack) detection program and 12‑lead ECG patch over scaling commercialization of its existing FDA‑cleared arrhythmia product.
The company will redirect most financial and human resources to clinical validation, algorithm development and regulatory work aimed at a future heart attack assessment indication, citing an internally estimated $15 billion MI opportunity within a broader >$40 billion cardiac platform market. Enrollment in the 134‑patient ALIGN‑ACS pilot study has been completed, and the 500‑patient HEADSTART‑ACS trial has passed 75% enrollment, with an FDA pre‑submission for a pivotal study filed in August.
HeartBeam will continue limited commercialization of its arrhythmia product and advance its 12‑lead patch toward FDA clearance, targeting a ~$2 billion market through strategic commercialization partners rather than building its own large sales infrastructure.
HeartBeam (NASDAQ: BEAT) reported second quarter 2026 results marked by clinical, commercial, and financial milestones. The company completed enrollment of 134 patients in its ALIGN-ACS heart attack detection pilot study ahead of schedule and surpassed 50% enrollment in the 500-patient Indonesian HEADSTART-ACS study, with full ALIGN-ACS results planned for TCT 2026.
HeartBeam finalized a working prototype of its 12-lead ECG extended wear patch and began a 50-patient pilot study, while advancing the initial commercial launch of the HeartBeam System for arrhythmia assessment, signing multiple agreements across four U.S. regions and shipping first orders. Q2 2026 operating expenses were $5.1 million and net loss was $5.0 million. Cash and cash equivalents rose to $8.7 million as of June 30, 2026, supported by an April public offering raising $11.5 million. The company lowered expected full-year 2026 net operating cash outflow to below $14.0 million, extending cash runway further into 2027.
HeartBeam (NASDAQ: BEAT) will host a conference call on Thursday, August 13, 2026 at 4:30 p.m. Eastern time to discuss second quarter 2026 results and provide updates on its ambulatory ECG signal platform strategy. A detailed earnings release will be issued before the call.
Executive Chairman Richard Ferrari, President and Founder Branislav Vajdic, Ph.D., and CFO Timothy Cruickshank will lead the call, with Q&A and an accompanying presentation available via webcast and later on the investor relations site. HeartBeam highlights its FDA-cleared 3D, cable-free ECG technology and over 25 issued patents.
HeartBeam (NASDAQ: BEAT) announced allowance of a new U.S. patent that extends its credit card-sized, cable-free ECG device with acoustic sensing and thoracic impedance capabilities. The patent covers integrating acoustic sensors into the device’s foldable arms to act as a “digital stethoscope” for assessing heart valve function, and adding thoracic impedance measurement via finger and chest electrodes to help detect fluid accumulation relevant to heart failure monitoring, without changing the form factor.
According to HeartBeam, this strengthens its multi-modal ambulatory cardiac sensing platform and brings its global portfolio to 26 issued patents spanning signal acquisition, ECG synthesis algorithms, diagnostic applications, and hardware across the HeartBeam System and its investigational on-demand 12-lead patch.
HeartBeam (NASDAQ: BEAT) completed enrollment ahead of schedule in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection. The study enrolled 120 chest-pain patients across two Serbia sites. Data analysis is underway and results are expected at an upcoming cardiology conference, guiding a planned U.S. pivotal study and a potential FDA submission to expand the system’s indication from arrhythmia to heart attack assessment.
HeartBeam (NASDAQ: BEAT) announced a strategic shift to license its 3D ambulatory ECG signal platform to established partners instead of focusing on direct device sales. A company-wide reorganization aims to enhance global reach, accelerate execution, and create a leaner cost structure, alongside a leadership transition as former CEO Robert Eno moves to a consulting role.
The strategy targets expansion from arrhythmia assessment into heart attack detection, adapts the platform to multiple form factors and channels, and builds on FDA clearance received in December 2025 for its synthesized 12-lead ECG signal for arrhythmia assessment.