Austin, Texas, United States, June 20th, 2025, FinanceWire
HeartBeam (NASDAQ: BEAT) announced it has received FDA 510(k) clearance for its flagship ECG system, a first-of-its-kind, credit card-sized, cable-free device designed to deliver high-fidelity, three-directional cardiac recordings for arrhythmia evaluation. The clearance marks a major regulatory milestone and accelerates HeartBeam’s plans to improve access to timely, remote cardiac care.
When symptoms arise, patients use the app-guided system to record a 30-second ECG, which is automatically uploaded to the cloud for physician review in the context of medical history. The company will soon launch an Early Access Program to engage early adopters and providers ahead of broader commercialization.
This foundational clearance also sets the stage for future advancements, including 12-lead ECG synthesis, AI-based arrhythmia detection, and remote heart attack risk scoring. HeartBeam’s long-term vision is to revolutionize cardiac care by enabling continuous, predictive insights outside traditional clinical settings.
To view the full press release, visit https://ibn.fm/go8CI
About HeartBeam Inc.
HeartBeam is a medical technology company dedicated to transforming cardiac care by providing powerful cardiac insights wherever the patient is. The company is creating the first-ever cable-free 12-lead ECG capable of capturing the heart’s electrical signals from three dimensions. This platform technology is designed to be used in portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care — all outside of a medical facility, thus redefining the future of cardiac health management. The company holds 13 U.S. and 4 international-issued patents related to technology enablement. For more information, visit www.HeartBeam.com
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