- 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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