HeartBeam, Inc.

HeartBeam to Present Results of ALIGN-ACS Study for Heart Attack Assessment at TCT 2026 on November 1, 2026

HeartBeam will present ALIGN-ACS pilot study results comparing its 3D ECG technology to a standard 12-lead ECG for acute coronary syndrome detection at TCT 2026 on November 1. The pilot enrolled 132 chest-pain patients across two sites in Belgrade, Serbia; results will inform the design of a U.S. pivotal study the company anticipates starting in Q1 2027. The heart-attack-assessment indication remains investigational, but the program carries FDA Breakthrough Device Designation and acceptance into the FDA's TAP program.

•4d ago

HeartBeam’s Heart Attack Assessment Technology Accepted into FDA’s Total Product Life Cycle Advisory Program (TAP) 

The FDA has accepted HeartBeam's HeartBeam System into the Total Product Life Cycle Advisory Program (TAP) Pilot for its 3D ECG heart attack assessment technology, awarded ahead of schedule. This follows Breakthrough Device Designation earlier in October, and TAP provides dedicated FDA advisors plus early engagement with payers including CMS, supporting the company's planned pivotal study with patient enrollment anticipated in Q1 2027. HeartBeam sizes its heart attack assessment opportunity at roughly $15 billion within a $40 billion-plus cardiac platform opportunity, though the system is not currently cleared for heart attack detection and TAP participation does not guarantee future authorization or coverage.

•6d ago

HEADSTART-ACS Completes Enrollment Ahead of Schedule, the Largest Heart Attack Detection Study to Date Using HeartBeam Technology

HeartBeam completed enrollment ahead of schedule in its HEADSTART-ACS study, the largest heart attack detection study using its technology, with 486 patients enrolled at Indonesia's National Cardiovascular Center Harapan Kita. Data analysis is underway with results expected at a cardiology conference in 2027; together with the 132-patient ALIGN-ACS pilot, HeartBeam now has clinical experience with more than 600 patients ahead of its U.S. pivotal study planned for Q1 2027. The HeartBeam System is not currently cleared for heart attack detection, so the study is investigational; the Indonesia partnership also signals a potential deployment opportunity across the country's 288-million-person market.

•11d ago

HeartBeam Joins European EXIT-CVD Research Consortium to Advance At-Home ECG Monitoring for Early Detection of Acute Coronary Syndrome (ACS) in High-Risk Patients

HeartBeam has joined the EU-funded EXIT-CVD research consortium alongside Philips, Medtronic, GE HealthCare and other global healthcare leaders, and will lead the HEART-CHECK study, one of the project's 22 clinical studies. HEART-CHECK will evaluate whether HeartBeam's at-home 3D ECG System can help clinicians detect recurrent cardiac events earlier in patients recently discharged after an acute coronary syndrome. HeartBeam's contribution is in-kind, and the System is not CE marked and is investigational in this setting. The consortium comprises 42 partners across 17 countries, 22 studies and more than 14,000 patients, with a total budget of EUR 27.6 million co-funded by the EU Innovative Health Initiative. The company notes FDA recently granted Breakthrough Device Designation for at-home heart attack assessment, and FDA clearance for heart attack assessment remains its priority.

•17d ago

HeartBeam Receives FDA Breakthrough Device Designation for Heart Attack Assessment

The FDA granted HeartBeam Breakthrough Device Designation for its HeartBeam System as a tool for assessing potential heart attacks at home, granted within 30 days of request versus a 60-day statutory window. The designation provides prioritized FDA interaction ahead of a planned multicenter pivotal study and is a prerequisite for expedited Medicare coverage pathways such as the proposed RAPID pathway; HeartBeam has also requested enrollment in the FDA's TAP program. Management sizes the MI assessment opportunity at approximately $15 billion within a $40 billion-plus cardiac platform opportunity, and expects updates on ALIGN-ACS data at TCT and the HEADSTART-ACS study in coming weeks.

•27d ago

HeartBeam Reports Second Quarter 2026 Results

HeartBeam reported second quarter 2026 results with a net loss of $5.0 million, or $0.10 per share, while highlighting the start of its commercial launch and ahead-of-schedule progress in clinical trials. The company strengthened its balance sheet to $8.7 million in cash following an April offering and reduced its net operating cash outflow guidance to below $14.0 million for the full year. Operational milestones included completing enrollment in the ALIGN-ACS pilot study and shipping first orders for the HeartBeam System in four targeted U.S. geographies.

•2mo ago

HeartBeam Awarded New U.S. Patent Expanding Acoustic Sensing and Fluid Monitoring Capabilities of Its Cable-Free ECG Device

HeartBeam was awarded a new U.S. patent that integrates acoustic sensing and thoracic impedance measurement into its cable-free ECG device, effectively adding digital stethoscope and fluid monitoring capabilities. The technology targets the 6.7 million U.S. adults with heart failure by enabling earlier detection of fluid accumulation without invasive procedures, potentially reducing hospitalization costs estimated at $30,000 per patient annually. This issuance brings the company's total issued patents to 26, though the new acoustic and impedance capabilities remain investigational and are not yet FDA cleared.

•3mo ago

HeartBeam Announces New Peer-Reviewed Article Demonstrating Potential to Help Identify Heart Attack Risk at Home

HeartBeam published a peer-reviewed study in JACC: Advances demonstrating that its ECG device, combined with clinical risk factors, can accurately identify heart attack risk. The algorithm achieved an AUC of 86.5% using a single ECG reading and 92.9% when compared against a patient's baseline ECG, significantly outperforming physician panels in false-positive rates. This proof-of-concept supports HeartBeam's planned expansion into acute coronary syndrome detection, a market addressing over 20 million high-risk patients in the U.S., while the company continues its ALIGN-ACS pilot study in Europe.

•4mo ago

HeartBeam Expands Commercial Presence Across Four Key U.S. Markets with Addition of Premier Concierge Practice

HeartBeam announced a commercial agreement with Atelier Health, adding a premier concierge practice in Southern California to its network. This partnership completes HeartBeam's initial launch footprint across New York, Dallas, South Florida, and Southern California, supporting its scalable go-to-market strategy in high-value, direct-pay care environments. The collaboration involves HeartBeam's patented cable-free 3D ECG technology, which allows patients to capture clinical-grade cardiac data at home for arrhythmia assessment.

•5mo ago