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Posted On: 06/20/2025 4:08:10 PM
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NetworkNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Earns FDA Clearance for First Cable-Free ECG System for Arrhythmia Detection
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.
NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://nnw.fm/BEAT
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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.
NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://nnw.fm/BEAT
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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