FDA 510(k) Clearance Progress
HeartBeam continues to anticipate FDA clearance for their 12-Lead ECG synthesis software by the end of the year, building on their previous FDA clearance received in December 2024.
Partnership with HeartNexus
HeartBeam announced a partnership with HeartNexus to provide on-demand board-certified cardiologist reviews, enhancing the company's commercial readiness.
Successful Clinical Trials
The VALID-ECG pivotal study demonstrated a 93.4% overall diagnostic agreement between HeartBeam's synthesized 12-Lead ECG and a standard 12-Lead ECG for arrhythmia assessment.
Cash Management and Financial Discipline
HeartBeam achieved an 8% decrease in net cash used in operating activities quarter-over-quarter, building on a previous 23% decrease, reflecting strong financial discipline.
Expansion of Intellectual Property
HeartBeam added 3 newly issued patents, bringing the total to 24, and was recognized as a global IP leader in portable cardiac diagnostics.