BEATW 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-13

• Our initial product and service offering is the HeartBeam System. The HeartBeam System is the first U.S. Food and Drug Administration (“FDA”) cleared cable-free, ambulatory synthesized 12L ECG that captures the heart’s electrical signals from three dimensions for high-fidelity data collection and ad…

• HeartBeam’s credit card sized 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the additional 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025. During the three months ended March 31, 2025 and March 31, 2026, the …

• We are focused on advancing several key initiatives as part of our growth strategy:

• Limited Launch: On the back of our recent FDA Clearance for the HeartBeam System, we are initiating a market introduction in early 2026, focusing on select concierge and preventive cardiology groups that have proactively signaled strong interest in adopting HeartBeam’s technology. This limited marke…

• In March 2026, the Company announced ClearCardio as its first commercial customer. ClearCardio is a leading preventive cardiology practice that has served thousands of patients through advanced heart health screening and personalized prevention programs. The partnership includes an initial staged ro…

相对上期删除的文字 · 来源:10-Q · 2025-11-13

• The HeartBeam System (previously referred to as “AIMIGOTM”) was granted FDA clearance on December 13, 2024. The HeartBeam System is the first U.S. Food and Drug Administration (“FDA”) cleared cable-free, ambulatory ECG that captures the heart’s electrical signals from three dimensions for high-fidel…

• In January 2025, the Company filed a 510(k) application for the software algorithms that synthesize a 12L ECG from the 3-Lead ECG recorded signal obtained by the HeartBeam System. The software synthesizes these signals into a familiar 12L ECG display, using a personalized transformation matrix. This…

• In April 2025, the VALID-ECG pivotal study results were presented at the Heart Rhythm Society conference. The study evaluated the mean difference in ECG intervals and amplitudes between HeartBeam’s synthesized 12L ECG and a simultaneously collected standard 12L ECG. Intervals and amplitudes are impo…

• The Company is focused on commercial readiness activities, in advance of an anticipated commercial launch that will occur once we receive FDA clearance for our 12L synthesis software.

• The Company initiated an early access program (the “Early Access Program”) for the HeartBeam System. This program is providing the Company with valuable feedback on the user experience, overall workflow and functionality of the system in a real-world setting. We do not anticipate that the Early Acce…