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By: NewMediaWire
September 15, 2025

Curated TLDR

HeartBeam (BEAT) Prepares Innovative ECG Tech for Commercial Launch

LOS ANGELES, CA - September 15, 2025 (NEWMEDIAWIRE) - 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).

  • 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 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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Forward Looking Statements

Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management's control, including the risks set forth under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of the Company's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of the Company's Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law.

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