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HeartBeam Advances Toward FDA Clearance for Revolutionary 12-Lead ECG Technology

By FisherVista

TL;DR

HeartBeam's FDA-cleared 3D ECG technology and pending 12-lead software offer a first-mover advantage in portable cardiac monitoring with 24 issued patents protecting the platform.

HeartBeam's 12-lead ECG synthesis software is in final FDA 510(k) review stage with expected clearance by year end and partners with HeartNexus for 24/7 cardiologist review services.

HeartBeam's portable 3D ECG technology enables cardiac monitoring outside medical facilities, improving early detection and directing patients to appropriate care for better health outcomes.

HeartBeam created the first cable-free device that collects ECG signals in 3D and synthesizes them into 12-lead ECGs, transforming how cardiac conditions are detected.

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HeartBeam Advances Toward FDA Clearance for Revolutionary 12-Lead ECG Technology

HeartBeam Inc. (NASDAQ: BEAT) has reported third-quarter 2025 financial results while making substantial progress toward commercializing its innovative 12-lead ECG synthesis software, currently in the final stage of FDA 510(k) review with anticipated clearance expected by year end. The company's advancement represents a potential paradigm shift in cardiac care, enabling comprehensive heart monitoring outside traditional medical settings.

The technology's importance lies in its ability to transform cardiac detection and monitoring through the first-ever cable-free device capable of collecting ECG signals in three dimensions from non-coplanar directions and synthesizing them into a clinical-grade 12-lead ECG. This breakthrough could significantly impact patient care by allowing physicians to identify cardiac health trends and acute conditions while patients remain in their homes or workplaces, potentially reducing emergency room visits and hospitalizations for cardiac events.

HeartBeam is accelerating commercial readiness through strategic partnerships, including a new collaboration with HeartNexus for 24/7 cardiologist review services. This partnership enhances the company's ecosystem by providing professional medical oversight for the data collected by its portable devices. The company's progress is documented in their latest financial reporting available at https://nnw.fm/pnnUx.

Recent scientific validation includes new data presented at both the American Heart Association Scientific Sessions and HRX Live 2025, reinforcing the technology's clinical relevance and potential impact on cardiac care standards. The company has also strengthened its intellectual property position, now holding 24 issued patents globally related to its core technology enablement.

Financially, the company reported third-quarter 2025 research and development expenses of $3.3 million and general and administrative expenses of $2.0 million, resulting in a net loss of $5.3 million. The company maintained cash reserves of $1.9 million as it progresses toward commercialization. Investors can access additional information through the company's newsroom at https://nnw.fm/BEAT.

The technology's potential extends beyond acute care to ongoing cardiac monitoring, representing a significant advancement in telemedicine and remote patient monitoring. With the company's 3D ECG technology already receiving FDA clearance for arrhythmia assessment in December 2024, the pending 12-lead ECG software clearance could complete the platform's capabilities for comprehensive cardiac assessment outside medical facilities.

This development matters because it addresses critical gaps in current cardiac care, particularly for patients who experience symptoms intermittently or in non-clinical settings. The ability to capture professional-grade ECG data during symptomatic episodes could lead to earlier detection of cardiac conditions, more accurate diagnosis, and potentially life-saving interventions. The technology's portability and ease of use could democratize access to advanced cardiac monitoring, benefiting patients in rural areas, those with mobility limitations, and individuals who cannot easily access medical facilities for routine monitoring.

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FisherVista

FisherVista

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