FDA Grants HeartBeam Breakthrough Device Designation Within 30 Days, Without Marketing Authorization
Key Facts
The U.S. Food and Drug Administration granted HeartBeam’s system Breakthrough Device designation as a potential tool for assessing heart attacks at home, the company announced in October 2026. HeartBeam said the agency issued the designation within 30 days of its request, before the end of the statutory 60-day review period. The step does not mean the device has been cleared for marketing to detect heart attacks. In a subsequent disclosure dated October 21, the company said the system is “not currently cleared to detect heart attacks” and that its use in the HEADSTART-ACS and ALIGN-ACS studies remains investigational. The regulatory path for this use therefore remains tied to completing the studies and aligning with agency requirements.
The FDA says its Breakthrough Devices Program can provide priority review and more frequent communication with the agency during development. Devices granted the designation must still meet rigorous safety and effectiveness standards before receiving marketing authorization. For HeartBeam, the significance of the step is that it opens an interactive regulatory pathway; it does not determine the outcome of the evaluation or grant the right to sell the device for this use. The company said the designation was based on proof-of-concept data presented at the American Heart Association’s scientific sessions in 2025. It also drew on results from the pilot ALIGN-ACS study, which included 134 patients—preliminary evidence within a clinical program that is not yet complete.
In the latest announced clinical progress, the HEADSTART-ACS study was completed after enrolling 486 patients at Indonesia’s National Cardiovascular Center Harapan Kita. HeartBeam said data analysis is underway and that it expects to present the results at a cardiology conference during 2027. The study included patients who arrived at the emergency department with chest pain and underwent a standard 12-lead electrocardiogram alongside the system’s three-dimensional recording. The results of the two tests are compared with each patient’s final discharge diagnosis, according to the company’s description of the study design. The company said the HEADSTART-ACS and ALIGN-ACS studies together enrolled more than 600 patients in research evaluating heart attacks.
ALIGN-ACS included 134 patients with chest pain in the emergency department at two clinical sites in Belgrade, Serbia. Participants underwent a standard 12-lead electrocardiogram and testing with the HeartBeam device, and the results were then compared with the final discharge diagnosis. The company said the study’s full results will be presented at the TCT conference in San Diego from October 31 to November 3, 2026. Data from this pilot study, together with the proof-of-concept data presented in 2025, formed part of the basis on which the agency granted the designation. The company’s pivotal U.S. study is scheduled to begin during the first quarter of 2027, after the company said it expects to seek the agency’s alignment on a multicenter study design and begin enrollment afterward.
The HeartBeam system captures electrical signals from the heart in three non-parallel dimensions, and the company describes it as a credit-card-sized device with no cables. The company already has agency clearances for other uses: its three-dimensional electrocardiogram technology was cleared to assess arrhythmia in December 2024, followed by software for generating a synthetic 12-lead electrocardiogram cleared for the same purpose in December 2025. Those clearances do not cover assessment of heart attacks, the use being tested in the two current studies. HEADSTART-ACS was conducted in collaboration with the Indonesian center, and the company said Indonesia is a strategically important market with a population of 288 million. In trading, BEAT shares closed at $0.3933 on October 23, compared with closes of $0.3981 on October 22, $0.407 on October 21, $0.4108 on October 20 and $0.413 on October 19; this sequence does not establish the reason for the share-price movement.