HeartBeam Inc. Achieves Clinical Success with 93.4% Diagnostic Agreement in VALID-ECG Study, Advances Toward Commercial Readiness

Reuters
14 May
HeartBeam Inc. Achieves Clinical Success with 93.4% Diagnostic Agreement in VALID-ECG Study, Advances Toward Commercial Readiness

HeartBeam, Inc., a medical technology company focused on cardiac care, has reported its financial and operational results for the first quarter ending March 31, 2025. The company achieved significant milestones towards commercial readiness, particularly with the HeartBeam System. A notable accomplishment was the successful completion of the VALID-ECG pivotal study, which enrolled 198 patients across five US sites for arrhythmia assessment. The study found a 93.4% overall diagnostic agreement, demonstrating that the synthesized 12-lead ECG supports arrhythmia diagnosis comparably to standard 12-lead ECGs. Additionally, HeartBeam engaged in productive discussions with the FDA regarding a 510(k) submission for its innovative 12-lead Electrocardiogram $(ECG.AU)$ synthesis software. The company also entered into a strategic collaboration with AccurKardia to enhance its commercial offering for arrhythmia assessment. Furthermore, HeartBeam expanded its intellectual property portfolio by adding two new US patents, strengthening its position in remote cardiac diagnostics. Management will host a webcast and conference call to discuss these developments, accompanied by a presentation accessible via the company's investor relations website.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Heartbeam Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250513490910) on May 13, 2025, and is solely responsible for the information contained therein.

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