This section highlights FDA-related milestones and regulatory updates for drugs developed by HeartBeam (BEAT).
Over the past two years, HeartBeam has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
HEADSTART-ACS, HeartBeam, and ALIGN-ACS. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
HEADSTART-ACS FDA Regulatory Events
HEADSTART-ACS is a drug developed by HeartBeam for the following indication: in detecting acute coronary syndrome.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HEADSTART-ACS
- Announced Date:
- October 21, 2026
- Indication:
- in detecting acute coronary syndrome
Announcement
HeartBeam, Inc announced that the HEADSTART-ACS study, conducted at the National Cardiovascular Center Harapan Kita in Jakarta, Indonesia, has completed enrollment ahead of schedule.
Read Announcement- Drug:
- HEADSTART-ACS
- Announced Date:
- October 21, 2026
- Indication:
- in detecting acute coronary syndrome
Announcement
HeartBeam, Inc. announced that the study enrolled 486 patients with data analysis underway and the results anticipated to be presented at a cardiology conference in 2027.
Read Announcement
HeartBeam system FDA Regulatory Events
HeartBeam system is a drug developed by HeartBeam for the following indication: For comprehensive arrhythmia assessment.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HeartBeam system
- Announced Date:
- October 5, 2026
- Indication:
- For comprehensive arrhythmia assessment.
Announcement
HeartBeam, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the HeartBeam System as a tool for assessing potential heart attacks at home.
Read Announcement- Drug:
- HeartBeam system
- Announced Date:
- December 16, 2024
- Indication:
- For comprehensive arrhythmia assessment.
Announcement
HeartBeam, Inc announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance of the HeartBeam system for comprehensive arrhythmia assessment announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance of the HeartBeam system for comprehensive arrhythmia assessment..
AI Summary
HeartBeam, Inc recently announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its innovative HeartBeam system, which is designed for comprehensive arrhythmia assessment. This clearance means that the HeartBeam system has met the FDA’s safety and effectiveness standards. The technology can help healthcare providers quickly and accurately detect irregular heart rhythms, leading to more timely and effective treatment. Clinicians now have a new tool that combines modern digital monitoring with established diagnostic practices.
The approval of this system is an important step forward for both patients and medical professionals. With enhanced heart monitoring capabilities, the HeartBeam system could improve patient care by offering a more efficient way to assess and manage arrhythmias. This milestone demonstrates ongoing advances in medical technology that aim to better support early detection and treatment of heart conditions.
Read Announcement
ALIGN-ACS FDA Regulatory Events
ALIGN-ACS is a drug developed by HeartBeam for the following indication: for heart attack detection.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ALIGN-ACS
- Announced Date:
- June 30, 2026
- Indication:
- for heart attack detection
Announcement
HeartBeam, Inc. announced completion of patient enrollment in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection.
AI Summary
HeartBeam, Inc. announced that it has completed patient enrollment in its ALIGN-ACS pilot study, which is testing the HeartBeam System for heart attack detection. This is an important step in the company’s work to expand how the system can be used and to support its broader platform strategy. The study is designed to evaluate whether the technology can help identify heart attacks more effectively.
HeartBeam says this milestone brings it closer to its goal of offering a potentially life-changing tool to more patients as soon as possible. The company believes the results from ALIGN-ACS could help support its long-term plan for an expanded indication for heart attack detection.
Read Announcement
