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HeartBeam Q3 2025 Results and FDA Review Progress FAQ
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 is developing the first cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing them into a 12-lead ECG, designed for portable use outside medical facilities to detect and monitor cardiac conditions.
The company's 12-lead ECG synthesis software is in the final stage of FDA 510(k) review with anticipated clearance expected by the end of the year.
For Q3 2025, HeartBeam reported R&D expenses of $3.3 million, G&A expenses of $2.0 million, a net loss of $5.3 million, and cash totaling $1.9 million.
HeartBeam has partnered with HeartNexus to provide 24/7 cardiologist review services as part of its commercial readiness acceleration.
The company now holds 24 issued patents globally related to technology enablement, strengthening its competitive position and protecting its innovative 3D ECG technology platform.
HeartBeam will discuss its results and provide a business update during a conference call and webcast on November 13 at 4:30 p.m. ET, with additional information available in the company's newsroom at https://nnw.fm/BEAT.
New scientific data supporting HeartBeam's technology was presented at the AHA Scientific Sessions and HRX Live 2025 conferences.
HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, prior to the current 12-lead ECG synthesis software under review.
The technology enables physicians to identify cardiac health trends and acute conditions outside medical facilities, allowing patients to receive actionable heart intelligence wherever they are and directing them to appropriate care.
The full press release is available at https://nnw.fm/pnnUx, and the latest news and updates relating to BEAT are available in the company's newsroom at https://nnw.fm/BEAT.
Curated from InvestorBrandNetwork (IBN)
