FDA Submission Progress
HeartBeam's 510(k) submission is progressing through active review by the FDA. The company remains optimistic about achieving foundational FDA clearance, which is a major milestone for future submissions.
Innovative Cardiac Care Technology
HeartBeam has developed a cable-free 12-lead ECG using a vector-based approach, capturing high-resolution heart signals. The technology addresses multiple large markets worth over $100 billion annually in the U.S.
Significant Clinical Evidence
HeartBeam has 9 peer-reviewed publications from studies with over 500 patients. Upcoming presentations at the American Heart Association Conference will further demonstrate the technology's potential.
Recognition and Awards
HeartBeam was named Rising Star at the Digital Health Hub Foundation Awards and received a MedTech Breakthrough Award for best new ECG technology solution.
Management Team Expansion
HeartBeam has strengthened its team with new appointments, including Tim Cruickshank as CFO and Lance Myers as Chief AI Officer, positioning the company for commercialization.