
HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights, reported financial and operational results for the fourth quarter and full year ended Dec. 31, 2025, highlighting progress toward commercialization following U.S. Food and Drug Administration (“FDA”) 510(k) clearance of its 12-lead electrocardiogram (“ECG”) synthesis software in December 2025. The company has initiated a limited market launch targeting concierge and preventive cardiology groups and secured its first commercial partnership with ClearCardio(TM), while also enrolling initial patients in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection. Additional developments include completion of a prototype extended-wear 12-lead ECG patch, a strategic collaboration with the Icahn School of Medicine at Mount Sinai to advance AI-enabled ECG algorithms and the appointment of a new chief commercial officer to support growth initiatives.
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At a glance
- Company
- HeartBeam, Inc.
- Ticker
- NASDAQ: BEAT
- Announcement
- Earnings
Key figures
- Issued patents
- over 20
Products and programs
About HeartBeam, Inc.
HeartBeam, Inc. is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company is creating the first-ever cable-free device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-lead ECG synthesis software in December 2025(1). The Company holds over 20 issued patents related to technology enablement.
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In brief
HeartBeam reported fourth-quarter and full-year 2025 results and described progress in commercialization and clinical development. The company says it began a limited launch of its 12-lead ECG synthesis software, following FDA clearance in December 2025, with a focus on concierge and preventive cardiology practices. It also secured a commercial partnership with ClearCardio and enrolled initial participants in its ALIGN-ACS pilot study, which is evaluating the HeartBeam System for heart attack detection. Other updates include a prototype of an extended-wear ECG patch, a collaboration with the Icahn School of Medicine at Mount Sinai on AI-enabled ECG algorithms, and the appointment of a chief commercial officer. HeartBeam also noted that its 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and that it holds over 20 issued patents.
Key takeaways
- HeartBeam says it has started a limited commercial launch of its 12-lead ECG synthesis software.
- ClearCardio is the company’s first commercial partner, according to the release.
- Initial patients have enrolled in the ALIGN-ACS pilot study for heart attack detection.
- The company reported an extended-wear ECG patch prototype and an AI-focused collaboration with Mount Sinai.
SEC filings
Earlier from HeartBeam, Inc.
- HeartBeam (NASDAQ: BEAT) Collaborates With Mount Sinai to Advance AI-ECG Algorithm Development
- HeartBeam (NASDAQ: BEAT) Management to Participate in March 2026 Investor and Industry Conferences
- HeartBeam (NASDAQ: BEAT) Enrolls First Patients in ALIGN-ACS Pilot Study for Heart Attack Detection
- HeartBeam (NASDAQ: BEAT) Announces Commercial Partnership With ClearCardio
- HeartBeam (NASDAQ: BEAT) Upgraded to Buy as New Joseph Gunnar Report Raises Price Target