Curated News
By: NewsRamp Editorial Staff
November 14, 2025
HeartBeam's 12-Lead ECG Software Nears FDA Clearance in Q3 2025
TLDR
- 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.
Impact - Why it Matters
This development matters because it represents a fundamental shift in cardiac care accessibility. Traditional 12-lead ECGs require bulky equipment and clinical settings, limiting timely detection of heart conditions. HeartBeam's portable, cable-free technology enables remote monitoring and early intervention for conditions like heart attacks and arrhythmias, potentially saving lives by allowing immediate cardiac assessment anywhere. For the millions at risk of cardiovascular disease, this technology could mean faster diagnosis, reduced hospital visits, and more proactive heart health management. The FDA clearance would validate a new standard in telemedicine and remote patient monitoring, addressing critical gaps in current cardiac care infrastructure.
Summary
HeartBeam (NASDAQ: BEAT) has reported significant progress in its third-quarter 2025 results, with the company's groundbreaking 12-lead ECG synthesis software now in the final stage of FDA 510(k) review and anticipated clearance by year end. The medical technology company is advancing commercial readiness through strategic partnerships, including a new collaboration with HeartNexus for 24/7 cardiologist review services that will complement their innovative platform. HeartBeam's technology represents a transformative approach to cardiac care, creating the first-ever cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing them into comprehensive 12-lead ECGs. This platform technology is designed for portable devices that can be used wherever the patient is located, delivering actionable heart intelligence directly to physicians outside traditional medical facilities.
The company's financial results show R&D expenses of $3.3 million and G&A expenses of $2.0 million for the quarter, with a net loss of $5.3 million and cash reserves totaling $1.9 million. Beyond the regulatory progress, HeartBeam has strengthened its position with new scientific data presented at major medical conferences including AHA Scientific Sessions and HRX Live 2025, while expanding its global intellectual property portfolio to 24 issued patents. The company's 3D ECG technology already received FDA clearance for arrhythmia assessment in December 2024, demonstrating the viability of their approach. HeartBeam's comprehensive InvestorBrandNetwork presence and strategic communications through NetworkNewsWire ensure broad market awareness as they approach this critical commercialization phase, with the company scheduled to discuss results and provide a business update during a conference call and webcast on November 13.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, HeartBeam's 12-Lead ECG Software Nears FDA Clearance in Q3 2025
