Austin, Texas, United States, September 15th, 2025, FinanceWire
Company releases report updating status of proprietary 12-lead ECG synthesis software for arrhythmia assessment. Earlier this year, HeartBeam submitted its software application to the U.S. Food and Drug Administration. Plans will ensure that healthcare providers and patients can seamlessly integrate the HeartBeam system into clinical workflows and home-monitoring routines.
In its most recent quarterly update, HeartBeam (NASDAQ: BEAT) is reporting that the company is on the verge of revolutionizing cardiac diagnostics with its groundbreaking ECG technology. The company is actively preparing for FDA 510(k) clearance of its innovative 12-lead ECG synthesis software for arrhythmia assessment while executing comprehensive commercial readiness plans for a technology that could transform how heart health is monitored both in clinical and home settings (https://ibn.fm/dz7rY).
“In the quarter, we continued to engage in positive and productive discussions with the FDA on the 12-lead ECG synthesis software submission for arrhythmia assessment, and we continue to anticipate clearance by the end of the year. . . . That clearance, together with our foundational clearance, will form…
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