HeartBeam Reports Q4 and Full-Year 2025 Results, Advances Commercialization and Clinical Development

HeartBeam reported progress toward commercialization of its FDA-cleared 12-lead ECG synthesis software, including a limited market launch and first commercial partnership, while advancing clinical studies and AI collaborations.

Miami Metrowire Staff
Healthcare
HeartBeam Reports Q4 and Full-Year 2025 Results, Advances Commercialization and Clinical Development

HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care, reported financial and operational results for the fourth quarter and full year ended Dec. 31, 2025. The company highlighted key milestones following U.S. Food and Drug Administration (FDA) 510(k) clearance of its 12-lead electrocardiogram (ECG) synthesis software in December 2025, including the initiation of a limited market launch targeting concierge and preventive cardiology groups and the securing of its first commercial partnership with ClearCardio.

The company also enrolled initial patients in its ALIGN-ACS pilot study, which evaluates the HeartBeam System for heart attack detection. Additionally, HeartBeam completed a prototype of an extended-wear 12-lead ECG patch and announced a strategic collaboration with the Icahn School of Medicine at Mount Sinai to advance AI-enabled ECG algorithms. To support growth initiatives, the company appointed a new chief commercial officer.

HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-lead ECG synthesis software in December 2025. The company holds over 20 issued patents related to technology enablement. The full press release is available at https://ibn.fm/3KQqG.

Forward-looking statements in this article involve risks and uncertainties as detailed in the company's filings with the Securities and Exchange Commission. The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT.

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