Curated News
By: NewsRamp Editorial Staff
October 21, 2026
HeartBeam Completes Enrollment in HEADSTART-ACS Study
TLDR
- HeartBeam finished its 486-patient HEADSTART-ACS study early, advancing its 3D ECG toward a pivotal U.S. trial in 2027.
- The HEADSTART-ACS study compares HeartBeam's 3D ECG against standard 12-lead ECGs to detect acute coronary syndrome in 486 patients.
- HeartBeam's portable ECG technology could bring faster heart attack detection to underserved communities, starting with health centers in Indonesia.
- HeartBeam's credit card-sized device captures ECG signals in 3D and synthesizes them into a 12-lead ECG without cables.
Impact - Why it Matters
This news matters because it signals progress toward a portable, patient-friendly alternative to traditional 12-lead ECGs for detecting heart attacks. If validated, HeartBeam’s 3D ECG technology could enable faster, more accessible cardiac monitoring outside hospitals, potentially saving lives through earlier detection. The completion of enrollment in HEADSTART-ACS, combined with the ALIGN-ACS pilot, brings HeartBeam closer to a pivotal U.S. study and eventual regulatory clearance, which could reshape how acute coronary syndrome is diagnosed in emergency and community settings. For investors, the milestone de-risks the clinical pathway and highlights the company’s growing evidence base.
Summary
HeartBeam (NASDAQ: BEAT), a medical technology company developing advanced cardiac monitoring solutions, has completed enrollment ahead of schedule in its HEADSTART-ACS study at the National Cardiovascular Center Harapan Kita in Jakarta, Indonesia. The study enrolled 486 patients to evaluate the diagnostic accuracy of the HeartBeam System in detecting acute coronary syndrome (ACS), including heart attacks, by comparing its three-dimensional electrocardiogram (ECG) technology with standard 12-lead ECGs. Data analysis is underway, with results expected to be presented at a cardiology conference in 2027.
Combined with the 132-patient ALIGN-ACS pilot study, HeartBeam has now enrolled more than 600 patients across its heart attack detection studies, supporting preparations for a pivotal U.S. study planned for the first quarter of 2027. The company is also exploring potential deployment of its portable, credit card-sized technology across community health centers in Indonesia. The HeartBeam System is not currently cleared for heart attack detection, and its use in both studies remains investigational.
HeartBeam is dedicated to transforming the detection and monitoring of critical cardiac conditions. Its cable-free device collects ECG signals in 3D from three non-coplanar directions and synthesizes them into a 12-lead ECG, designed for portable use wherever the patient is. The company’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-lead ECG synthesis software in December 2025. HeartBeam holds over 20 issued patents related to technology enablement. For more information, visit https://ibn.fm/1c6Br.
Source Statement
This curated news summary relied on content distributed by InvestorBrandNetwork (IBN). Read the original source here, HeartBeam Completes Enrollment in HEADSTART-ACS Study
